Trial Outcomes & Findings for A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC (NCT NCT03764293)
NCT ID: NCT03764293
Last Updated: 2024-02-06
Results Overview
OS was defined as the time from randomization to death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
543 participants
Primary outcome timeframe
Up to approximately 3 years
Results posted on
2024-02-06
Participant Flow
Participant milestones
| Measure |
Camrelizumab+Rivoceranib Arm
Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.
Camrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.
|
Sorafenib Arm
Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.
|
|---|---|---|
|
Overall Study
STARTED
|
272
|
271
|
|
Overall Study
Treated
|
272
|
269
|
|
Overall Study
COMPLETED
|
230
|
249
|
|
Overall Study
NOT COMPLETED
|
42
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC
Baseline characteristics by cohort
| Measure |
Camrelizumab+Rivoceranib Arm
n=272 Participants
Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.
Camrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.
|
Sorafenib Arm
n=271 Participants
Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.
|
Total
n=543 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 Years
|
191 participants
n=99 Participants
|
210 participants
n=107 Participants
|
401 participants
n=206 Participants
|
|
Age, Customized
>=65 Years
|
81 participants
n=99 Participants
|
61 participants
n=107 Participants
|
142 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
227 Participants
n=99 Participants
|
230 Participants
n=107 Participants
|
457 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
226 Participants
n=99 Participants
|
224 Participants
n=107 Participants
|
450 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
44 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 3 yearsOS was defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Camrelizumab+Rivoceranib Arm
n=272 Participants
Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.
Camrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.
|
Sorafenib Arm
n=271 Participants
Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.
|
|---|---|---|
|
Overall Survival (OS)
|
22.1 months
Interval 19.1 to 27.2
|
15.2 months
Interval 13.0 to 18.5
|
PRIMARY outcome
Timeframe: Up to approximately 3 yearsPFS was defined as the time from randomization to the first occurrence of progressive disease (PD) by tumor image evaluation or death from any cause whichever occurs first as determined by BIRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions and the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Camrelizumab+Rivoceranib Arm
n=272 Participants
Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.
Camrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.
|
Sorafenib Arm
n=271 Participants
Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.
|
|---|---|---|
|
Progression-free Survival (PFS) Evaluated by the Blinded Independent Review Committee (BIRC) Based on RECIST v1.1
|
5.6 months
Interval 5.5 to 7.4
|
3.7 months
Interval 3.1 to 3.7
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsORR defined as the percentage of subjects with complete response (CR) or partial response (PR) evaluated by the BIRC or investigator based on RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Overall Response (OR)=CR+PR.
Outcome measures
| Measure |
Camrelizumab+Rivoceranib Arm
n=272 Participants
Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.
Camrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.
|
Sorafenib Arm
n=271 Participants
Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
25 percentage of participants
Interval 20.0 to 31.0
|
6 percentage of participants
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsDCR defined as the percentage of subjects with complete response, partial response or stable disease (SD) ≥ 8 weeks evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Camrelizumab+Rivoceranib Arm
n=272 Participants
Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.
Camrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.
|
Sorafenib Arm
n=271 Participants
Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
78 percentage of participants
Interval 73.0 to 83.0
|
54 percentage of participants
Interval 48.0 to 60.0
|
SECONDARY outcome
Timeframe: Up to approximately 3 yearsDOR defined as time from the date of first record of objective response (CR or PR) to the first occurrence of radiological progression or death, whichever comes first, evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Camrelizumab+Rivoceranib Arm
n=272 Participants
Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.
Camrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.
|
Sorafenib Arm
n=271 Participants
Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.
|
|---|---|---|
|
Duration of Response (DOR)
|
14.8 months
Interval 8.4 to
NA=the 75-percentile DOR is not reached and hence the upper limit of the 95% CI of the median DOR is not estimable due to a lot of censoring and not enough disease progressions/events.
|
9.2 months
Interval 5.3 to
NA=the 75-percentile DOR is not reached and hence the upper limit of the 95% CI of the median DOR is not estimable due to a lot of censoring and not enough disease progressions/events.
|
Adverse Events
Camrelizumab+Rivoceranib Arm
Serious events: 114 serious events
Other events: 268 other events
Deaths: 34 deaths
Sorafenib Arm
Serious events: 49 serious events
Other events: 262 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Camrelizumab+Rivoceranib Arm
n=272 participants at risk
Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.
Camrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.
|
Sorafenib Arm
n=269 participants at risk
Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.
|
|---|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
4.4%
12/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
4/272 • Up to approximately 3 years
|
1.5%
4/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Ascites
|
1.5%
4/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
3/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
3/272 • Up to approximately 3 years
|
0.74%
2/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.74%
2/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.74%
2/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.74%
2/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Gastriculcer
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Immune-mediated pancreatitis
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
4.4%
12/272 • Up to approximately 3 years
|
0.74%
2/269 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
3.7%
10/272 • Up to approximately 3 years
|
1.5%
4/269 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.74%
2/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal neoplasm
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.37%
1/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral neoplasm
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
10/272 • Up to approximately 3 years
|
0.74%
2/269 • Up to approximately 3 years
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
8/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Investigations
Blood bilirubin increased
|
2.9%
8/272 • Up to approximately 3 years
|
0.74%
2/269 • Up to approximately 3 years
|
|
Investigations
Platelet count decreased
|
1.8%
5/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.74%
2/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Investigations
Bilirubin conjugated increased
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Investigations
Neutrophil count decreased
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Investigations
White blood cell count decreased
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
1.5%
4/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
1.1%
3/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.1%
3/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Bile duct stone
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Hepatic failure
|
0.37%
1/272 • Up to approximately 3 years
|
0.74%
2/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Liver injury
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Nervous system disorders
Hepatic encephalopathy
|
3.7%
10/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Nervous system disorders
Cerebral infarction
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Nervous system disorders
Loss of consciousness
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Nervous system disorders
Myasthenic syndrome
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/272 • Up to approximately 3 years
|
0.74%
2/269 • Up to approximately 3 years
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Infections and infestations
Urinary tract infection
|
1.1%
3/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Infections and infestations
COVID-19
|
0.74%
2/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Infections and infestations
Sepsis
|
0.74%
2/272 • Up to approximately 3 years
|
0.74%
2/269 • Up to approximately 3 years
|
|
Infections and infestations
Abdominal sepsis
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Infections and infestations
Diverticulitis
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Infections and infestations
Erysipelas
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Infections and infestations
Periodontitis
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Infections and infestations
Peritonitis
|
0.37%
1/272 • Up to approximately 3 years
|
0.74%
2/269 • Up to approximately 3 years
|
|
Infections and infestations
Peritonitis bacterial
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/272 • Up to approximately 3 years
|
0.74%
2/269 • Up to approximately 3 years
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Infections and infestations
Febrile infection
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/272 • Up to approximately 3 years
|
0.74%
2/269 • Up to approximately 3 years
|
|
General disorders
Pyrexia
|
1.5%
4/272 • Up to approximately 3 years
|
0.74%
2/269 • Up to approximately 3 years
|
|
General disorders
Death
|
0.74%
2/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.74%
2/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
General disorders
Asthenia
|
0.37%
1/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
General disorders
Pain
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.74%
2/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.74%
2/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.74%
2/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
3/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.37%
1/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.37%
1/272 • Up to approximately 3 years
|
0.74%
2/269 • Up to approximately 3 years
|
|
Cardiac disorders
Cardiac failure
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Cardiac disorders
Coronary artery disease
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Immune system disorders
Reactive capillary endothelial proliferation
|
1.5%
4/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Renal and urinary disorders
Haematuria
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Renal and urinary disorders
Proteinuria
|
0.37%
1/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.1%
3/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Vascular disorders
Circulatory collapse
|
0.37%
1/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Vascular disorders
Hypertension
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Vascular disorders
Hypotension
|
0.37%
1/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.37%
1/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Eye disorders
Ulcerative keratitis
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Psychiatric disorders
Affective disorder
|
0.37%
1/272 • Up to approximately 3 years
|
0.00%
0/269 • Up to approximately 3 years
|
Other adverse events
| Measure |
Camrelizumab+Rivoceranib Arm
n=272 participants at risk
Camrelizumab+rivoceranib arm: Rivoceranib 250 mg orally, QD, within 30 minutes after a meal, continuously.
Camrelizumab 200 mg IV infusion, over 30 minutes, Q2W. The interval between two doses should not be less than 12 days.
|
Sorafenib Arm
n=269 participants at risk
Sorafenib arm: Sorafenib 400 mg orally, BID, in a fasted state (at least 1 hour before or 2 hours after a meal), continuously.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.1%
71/272 • Up to approximately 3 years
|
17.8%
48/269 • Up to approximately 3 years
|
|
Endocrine disorders
Hypothyroidism
|
21.7%
59/272 • Up to approximately 3 years
|
7.4%
20/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
33.1%
90/272 • Up to approximately 3 years
|
42.4%
114/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Nausea
|
16.5%
45/272 • Up to approximately 3 years
|
8.2%
22/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
13.2%
36/272 • Up to approximately 3 years
|
6.7%
18/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.8%
32/272 • Up to approximately 3 years
|
5.6%
15/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Vomiting
|
11.0%
30/272 • Up to approximately 3 years
|
6.7%
18/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
10.7%
29/272 • Up to approximately 3 years
|
12.3%
33/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Constipation
|
8.8%
24/272 • Up to approximately 3 years
|
7.4%
20/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Gingival bleeding
|
7.7%
21/272 • Up to approximately 3 years
|
5.9%
16/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Ascites
|
6.2%
17/272 • Up to approximately 3 years
|
5.9%
16/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
17/272 • Up to approximately 3 years
|
3.7%
10/269 • Up to approximately 3 years
|
|
Gastrointestinal disorders
Toothache
|
5.1%
14/272 • Up to approximately 3 years
|
3.0%
8/269 • Up to approximately 3 years
|
|
General disorders
Fatigue
|
25.0%
68/272 • Up to approximately 3 years
|
12.6%
34/269 • Up to approximately 3 years
|
|
General disorders
Pyrexia
|
16.5%
45/272 • Up to approximately 3 years
|
11.9%
32/269 • Up to approximately 3 years
|
|
General disorders
Asthenia
|
13.6%
37/272 • Up to approximately 3 years
|
8.6%
23/269 • Up to approximately 3 years
|
|
General disorders
Oedema peripheral
|
9.2%
25/272 • Up to approximately 3 years
|
1.5%
4/269 • Up to approximately 3 years
|
|
Immune system disorders
Reactive capillary endothelial proliferation
|
29.0%
79/272 • Up to approximately 3 years
|
0.37%
1/269 • Up to approximately 3 years
|
|
Infections and infestations
Upper respiratory tract infection
|
9.6%
26/272 • Up to approximately 3 years
|
5.6%
15/269 • Up to approximately 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
65.4%
178/272 • Up to approximately 3 years
|
50.9%
137/269 • Up to approximately 3 years
|
|
Investigations
Alanine aminotransferase increased
|
56.6%
154/272 • Up to approximately 3 years
|
42.8%
115/269 • Up to approximately 3 years
|
|
Investigations
Platelet count decreased
|
50.7%
138/272 • Up to approximately 3 years
|
39.0%
105/269 • Up to approximately 3 years
|
|
Investigations
Blood bilirubin increased
|
48.2%
131/272 • Up to approximately 3 years
|
41.6%
112/269 • Up to approximately 3 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
32.4%
88/272 • Up to approximately 3 years
|
29.7%
80/269 • Up to approximately 3 years
|
|
Investigations
White blood cell count decreased
|
29.0%
79/272 • Up to approximately 3 years
|
17.8%
48/269 • Up to approximately 3 years
|
|
Investigations
Neutrophil count decreased
|
28.7%
78/272 • Up to approximately 3 years
|
12.3%
33/269 • Up to approximately 3 years
|
|
Investigations
Weight decreased
|
24.6%
67/272 • Up to approximately 3 years
|
26.0%
70/269 • Up to approximately 3 years
|
|
Investigations
Blood alkaline phosphatase increased
|
23.2%
63/272 • Up to approximately 3 years
|
20.8%
56/269 • Up to approximately 3 years
|
|
Investigations
Bilirubin conjugated increased
|
19.5%
53/272 • Up to approximately 3 years
|
19.3%
52/269 • Up to approximately 3 years
|
|
Investigations
Blood bilirubin unconjugated increased
|
14.7%
40/272 • Up to approximately 3 years
|
12.3%
33/269 • Up to approximately 3 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
14.0%
38/272 • Up to approximately 3 years
|
13.8%
37/269 • Up to approximately 3 years
|
|
Investigations
Lymphocyte count decreased
|
10.7%
29/272 • Up to approximately 3 years
|
8.6%
23/269 • Up to approximately 3 years
|
|
Investigations
Amylase increased
|
10.3%
28/272 • Up to approximately 3 years
|
4.8%
13/269 • Up to approximately 3 years
|
|
Investigations
Blood thyroid stimulating hormone increased
|
9.6%
26/272 • Up to approximately 3 years
|
3.0%
8/269 • Up to approximately 3 years
|
|
Investigations
Total bile acids increased
|
9.2%
25/272 • Up to approximately 3 years
|
4.1%
11/269 • Up to approximately 3 years
|
|
Investigations
Urinary occult blood positive
|
9.2%
25/272 • Up to approximately 3 years
|
4.5%
12/269 • Up to approximately 3 years
|
|
Investigations
Lipase increased
|
8.1%
22/272 • Up to approximately 3 years
|
4.8%
13/269 • Up to approximately 3 years
|
|
Investigations
Occult blood positive
|
8.1%
22/272 • Up to approximately 3 years
|
7.4%
20/269 • Up to approximately 3 years
|
|
Investigations
Electrocardiogram QT prolonged
|
7.0%
19/272 • Up to approximately 3 years
|
3.7%
10/269 • Up to approximately 3 years
|
|
Investigations
Blood creatinine increased
|
5.9%
16/272 • Up to approximately 3 years
|
2.6%
7/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
30.9%
84/272 • Up to approximately 3 years
|
23.0%
62/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.3%
58/272 • Up to approximately 3 years
|
17.1%
46/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.5%
45/272 • Up to approximately 3 years
|
12.6%
34/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
34/272 • Up to approximately 3 years
|
8.2%
22/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.8%
32/272 • Up to approximately 3 years
|
5.6%
15/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
9.6%
26/272 • Up to approximately 3 years
|
17.8%
48/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.4%
20/272 • Up to approximately 3 years
|
3.0%
8/269 • Up to approximately 3 years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.0%
11/272 • Up to approximately 3 years
|
5.6%
15/269 • Up to approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.2%
36/272 • Up to approximately 3 years
|
8.2%
22/269 • Up to approximately 3 years
|
|
Nervous system disorders
Headache
|
14.3%
39/272 • Up to approximately 3 years
|
2.6%
7/269 • Up to approximately 3 years
|
|
Nervous system disorders
Dizziness
|
7.4%
20/272 • Up to approximately 3 years
|
2.2%
6/269 • Up to approximately 3 years
|
|
Psychiatric disorders
Insomnia
|
5.1%
14/272 • Up to approximately 3 years
|
4.5%
12/269 • Up to approximately 3 years
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
136/272 • Up to approximately 3 years
|
30.5%
82/269 • Up to approximately 3 years
|
|
Renal and urinary disorders
Haematuria
|
14.0%
38/272 • Up to approximately 3 years
|
6.7%
18/269 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
31/272 • Up to approximately 3 years
|
5.2%
14/269 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
9.6%
26/272 • Up to approximately 3 years
|
1.9%
5/269 • Up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
15/272 • Up to approximately 3 years
|
3.0%
8/269 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
37.1%
101/272 • Up to approximately 3 years
|
60.6%
163/269 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.8%
51/272 • Up to approximately 3 years
|
20.4%
55/269 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
21/272 • Up to approximately 3 years
|
4.8%
13/269 • Up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.5%
4/272 • Up to approximately 3 years
|
19.3%
52/269 • Up to approximately 3 years
|
|
Vascular disorders
Hypertension
|
69.9%
190/272 • Up to approximately 3 years
|
43.9%
118/269 • Up to approximately 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER