Trial Outcomes & Findings for Hepatic Artery Infusion Chemotherapy (HAIC) Plus Durvalumab for Advanced Hepatocellular Carcinoma (NCT NCT04945720)
NCT ID: NCT04945720
Last Updated: 2026-02-25
Results Overview
Percentage of patients who survived one year after inclusion
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
one year
Results posted on
2026-02-25
Participant Flow
Recruitment for this open-label, single-arm, phase 2 study was conducted at Sun Yat-sen University Cancer Center. Main inclusion criteria included a diagnosis of HCC, the presence of Vp3 or Vp4 PVTT, the presence of at least one measurable lesion, no prior systemic treatment, liver function classified as Child-Pugh class A-B7, ECOG performance status of 0-1, and adequate organ function.
Patients with hepatocellular carcinoma and Vp3-4 portal vein tumor thrombus were screened at Sun Yat-sen University Cancer Center according to protocol-defined inclusion and exclusion criteria. After providing written informed consent, all eligible patients were assigned to the single treatment arm and received study treatment.
Participant milestones
| Measure |
Study Group
All enrolled patients received durvalumab in combination with hepatic arterial infusion chemotherapy (HAIC) using a FOLFOX regimen. In each 21-day cycle, patients received HAIC with oxaliplatin 130 mg/m2, leucovorin 200 mg/m2, and fluorouracil 400 mg/m2 bolus followed by 2,400 mg/m2 continuous infusion over 46 hours on days 1-3. Durvalumab 1,120 mg was administered intravenously on day 7 (+/-2). HAIC-FOLFOX was continued for up to 8 cycles or until intolerance or investigator-determined unsuitability for further chemotherapy. Thereafter, patients without progression could continue durvalumab monotherapy at 1,500 mg intravenously every 28 days as maintenance treatment until radiologic disease progression, unacceptable toxicity, withdrawal of consent, or death, whichever occurred first. Tumor assessments were performed with contrast-enhanced abdominal CT or MRI and chest CT every 6-8 weeks according to RECIST v1.1; responses required confirmation at a subsequent assessment.
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|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hepatic Artery Infusion Chemotherapy（HAIC） Plus Durvalumab
n=30 Participants
The therapeutic scheme was modified FOLFOX6 regimens including oxaliplatin (130 mg/m2 infusion for 3 hours on day 1), leucovorin (200 mg/m2 from hour 3 to 5 on day 1) and Fluorouracil (400 mg/m2 in bolus, and then 2,400 mg/m2 continuous infusion 46 hours). All chemo-drugs were given by HAI.Patients received anti-PD-L1 agents will begin no earlier than 7 days following the first HAIC procedure. Anti-PD-L1 agents were used intravenously at the standard dose: Durvalumab was given every 3 weeks during HAIC treatment (Q3W) and every 4 weeks after HAIC treatment (Q4W).
|
|---|---|
|
Age, Continuous
|
50 year
n=30 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: All participants who received at least one dose of study treatment were included in the analysis population for this outcome.
Percentage of patients who survived one year after inclusion
Outcome measures
| Measure |
Study Group
n=30 Participants
All enrolled patients received durvalumab in combination with hepatic arterial infusion chemotherapy (HAIC) using a FOLFOX regimen. In each 21-day cycle, patients received HAIC with oxaliplatin 130 mg/m2, leucovorin 200 mg/m2, and fluorouracil 400 mg/m2 bolus followed by 2,400 mg/m2 continuous infusion over 46 hours on days 1-3. Durvalumab 1,120 mg was administered intravenously on day 7 (+/-2). HAIC-FOLFOX was continued for up to 8 cycles or until intolerance or investigator-determined unsuitability for further chemotherapy. Thereafter, patients without progression could continue durvalumab monotherapy at 1,500 mg intravenously every 28 days as maintenance treatment until radiologic disease progression, unacceptable toxicity, withdrawal of consent, or death, whichever occurred first. Tumor assessments were performed with contrast-enhanced abdominal CT or MRI and chest CT every 6-8 weeks according to RECIST v1.1; responses required confirmation at a subsequent assessment.
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|---|---|
|
One-Year Overall Survival Rate
|
16 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All participants who received at least one dose of study treatment were included in the analysis population for this outcome.
Progression free survival is defined as the interval from treatment initiation to either disease progression or death from any cause)
Outcome measures
| Measure |
Study Group
n=30 Participants
All enrolled patients received durvalumab in combination with hepatic arterial infusion chemotherapy (HAIC) using a FOLFOX regimen. In each 21-day cycle, patients received HAIC with oxaliplatin 130 mg/m2, leucovorin 200 mg/m2, and fluorouracil 400 mg/m2 bolus followed by 2,400 mg/m2 continuous infusion over 46 hours on days 1-3. Durvalumab 1,120 mg was administered intravenously on day 7 (+/-2). HAIC-FOLFOX was continued for up to 8 cycles or until intolerance or investigator-determined unsuitability for further chemotherapy. Thereafter, patients without progression could continue durvalumab monotherapy at 1,500 mg intravenously every 28 days as maintenance treatment until radiologic disease progression, unacceptable toxicity, withdrawal of consent, or death, whichever occurred first. Tumor assessments were performed with contrast-enhanced abdominal CT or MRI and chest CT every 6-8 weeks according to RECIST v1.1; responses required confirmation at a subsequent assessment.
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|---|---|
|
Progression Free Survival
|
9.0 month
Interval 4.5 to 12.2
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All participants who received at least one dose of study treatment were included in the analysis population for this outcome.
The percentage of patients who achieved a complete or partial response at some point in their life
Outcome measures
| Measure |
Study Group
n=30 Participants
All enrolled patients received durvalumab in combination with hepatic arterial infusion chemotherapy (HAIC) using a FOLFOX regimen. In each 21-day cycle, patients received HAIC with oxaliplatin 130 mg/m2, leucovorin 200 mg/m2, and fluorouracil 400 mg/m2 bolus followed by 2,400 mg/m2 continuous infusion over 46 hours on days 1-3. Durvalumab 1,120 mg was administered intravenously on day 7 (+/-2). HAIC-FOLFOX was continued for up to 8 cycles or until intolerance or investigator-determined unsuitability for further chemotherapy. Thereafter, patients without progression could continue durvalumab monotherapy at 1,500 mg intravenously every 28 days as maintenance treatment until radiologic disease progression, unacceptable toxicity, withdrawal of consent, or death, whichever occurred first. Tumor assessments were performed with contrast-enhanced abdominal CT or MRI and chest CT every 6-8 weeks according to RECIST v1.1; responses required confirmation at a subsequent assessment.
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|---|---|
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Objective Response Rate
|
16 Participants
|
Adverse Events
Study Group
Serious events: 8 serious events
Other events: 30 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Study Group
n=30 participants at risk
All enrolled patients received durvalumab in combination with hepatic arterial infusion chemotherapy (HAIC) using a FOLFOX regimen. In each 21-day cycle, patients received HAIC with oxaliplatin 130 mg/m2, leucovorin 200 mg/m2, and fluorouracil 400 mg/m2 bolus followed by 2,400 mg/m2 continuous infusion over 46 hours on days 1-3. Durvalumab 1,120 mg was administered intravenously on day 7 (+/-2). HAIC-FOLFOX was continued for up to 8 cycles or until intolerance or investigator-determined unsuitability for further chemotherapy. Thereafter, patients without progression could continue durvalumab monotherapy at 1,500 mg intravenously every 28 days as maintenance treatment until radiologic disease progression, unacceptable toxicity, withdrawal of consent, or death, whichever occurred first. Tumor assessments were performed with contrast-enhanced abdominal CT or MRI and chest CT every 6-8 weeks according to RECIST v1.1; responses required confirmation at a subsequent assessment.
|
|---|---|
|
Gastrointestinal disorders
diarrhea
|
3.3%
1/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Gastrointestinal disorders
gastrointestinal bleeding
|
13.3%
4/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Gastrointestinal disorders
ascites
|
3.3%
1/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Respiratory, thoracic and mediastinal disorders
pulmonitis
|
3.3%
1/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
3.3%
1/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
Other adverse events
| Measure |
Study Group
n=30 participants at risk
All enrolled patients received durvalumab in combination with hepatic arterial infusion chemotherapy (HAIC) using a FOLFOX regimen. In each 21-day cycle, patients received HAIC with oxaliplatin 130 mg/m2, leucovorin 200 mg/m2, and fluorouracil 400 mg/m2 bolus followed by 2,400 mg/m2 continuous infusion over 46 hours on days 1-3. Durvalumab 1,120 mg was administered intravenously on day 7 (+/-2). HAIC-FOLFOX was continued for up to 8 cycles or until intolerance or investigator-determined unsuitability for further chemotherapy. Thereafter, patients without progression could continue durvalumab monotherapy at 1,500 mg intravenously every 28 days as maintenance treatment until radiologic disease progression, unacceptable toxicity, withdrawal of consent, or death, whichever occurred first. Tumor assessments were performed with contrast-enhanced abdominal CT or MRI and chest CT every 6-8 weeks according to RECIST v1.1; responses required confirmation at a subsequent assessment.
|
|---|---|
|
Blood and lymphatic system disorders
hypoalbuminemia
|
76.7%
23/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Blood and lymphatic system disorders
reduced hemoglobin
|
73.3%
22/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
70.0%
21/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Blood and lymphatic system disorders
leukopenia
|
70.0%
21/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Blood and lymphatic system disorders
neutropenia
|
66.7%
20/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Hepatobiliary disorders
elevated AST
|
56.7%
17/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Infections and infestations
fever
|
56.7%
17/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Gastrointestinal disorders
pain abdominal
|
53.3%
16/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Hepatobiliary disorders
elevated total bilirubin
|
46.7%
14/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Hepatobiliary disorders
elevated ALT
|
40.0%
12/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
General disorders
nausea
|
36.7%
11/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
General disorders
vomiting
|
33.3%
10/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Blood and lymphatic system disorders
elevated INR
|
30.0%
9/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Gastrointestinal disorders
abdominal distension
|
26.7%
8/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Skin and subcutaneous tissue disorders
rash
|
26.7%
8/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Gastrointestinal disorders
diarrhea
|
23.3%
7/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Gastrointestinal disorders
ascites
|
23.3%
7/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Gastrointestinal disorders
constipation
|
13.3%
4/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Skin and subcutaneous tissue disorders
pruritus
|
13.3%
4/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
General disorders
weight reduction
|
13.3%
4/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Nervous system disorders
backache
|
10.0%
3/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Blood and lymphatic system disorders
gingival bleeding
|
10.0%
3/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Gastrointestinal disorders
hiccup
|
10.0%
3/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Nervous system disorders
dizziness
|
6.7%
2/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Renal and urinary disorders
elevated creatinine
|
6.7%
2/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
6.7%
2/30 • From enrollment through 30 days after the last study treatment, up to 18 months, an average of 9 months.
Adverse events were monitored throughout treatment, and safety profiles were evaluated with event severity graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place