Trial Outcomes & Findings for Sintilimab for the Treatment of Locally Advanced, Metastatic, or Recurrent Angiosarcoma, the SiARa Cancer Study (NCT NCT05026736)
NCT ID: NCT05026736
Last Updated: 2026-07-21
Results Overview
A patient was considered as a responder to the treatment if he/she had no confirmed progressive disease determined by RECIST 1.1 after 9 cycles of therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addtion, the sum must also demonstrate an absolute increaase of at least 5 mm. (Note: the appearmance of one or more new lesions is also considered progression).
TERMINATED
PHASE2
6 participants
Nine cycles of therapy (Each cycle consists of a 21-day period)
2026-07-21
Participant Flow
Participant milestones
| Measure |
Treatment (Sintilimab)
Participants receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Treatment (Sintilimab)
Participants receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Progression of disease
|
2
|
|
Overall Study
Drug supply exhausted
|
2
|
Baseline Characteristics
Sintilimab for the Treatment of Locally Advanced, Metastatic, or Recurrent Angiosarcoma, the SiARa Cancer Study
Baseline characteristics by cohort
| Measure |
Treatment (Sintilimab)
n=6 Participants
Participants receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Nine cycles of therapy (Each cycle consists of a 21-day period)Population: Patients who had at least one post treatment tumor assessment
A patient was considered as a responder to the treatment if he/she had no confirmed progressive disease determined by RECIST 1.1 after 9 cycles of therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addtion, the sum must also demonstrate an absolute increaase of at least 5 mm. (Note: the appearmance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Treatment (Sintilimab)
n=6 Participants
Participants receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Rate at 9 Cycles
|
67 Percentage of participants
Interval 20.0 to 90.0
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: Patients who had at least one post treatment tumor assessment
Objective response rate is defined as percentage of participants who have achieved a complete response or particial response per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1). Complete response is defined as disapperance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response is defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Treatment (Sintilimab)
n=6 Participants
Participants receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Objective Response Rate (Complete Response + Partial Response)
|
50 Percentage of participants
Interval 12.0 to 88.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients who have achieved a complete response or a partial response
Duration of response (DOR) was measured from the time measurement criteria were first met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded on study). Using RECIST v1.1, CR is 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. PR is defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD is defined as a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearmance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Treatment (Sintilimab)
n=3 Participants
Participants receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Duration of Response
|
22.3 months
Interval 19.7 to 24.8
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients who had at least one post treatment tumor assessment
Progression-free survival is defined as the time from treatment onset to either disease progression or death from any cause, or discontinuation of treatment for any reason, whichever occurs first
Outcome measures
| Measure |
Treatment (Sintilimab)
n=6 Participants
Participants receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression Free Survival
|
NA months
Interval 1.25 to
Not Reached due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 3 yearsOverall survival is defined as the time from treatment onset to death
Outcome measures
| Measure |
Treatment (Sintilimab)
n=6 Participants
Participants receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
NA months
Interval 6.83 to
Not Reached due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Nine cycles of therapy (Each cycle consists of a 21-day period)Population: Patients who had at least one post treatment tumor assessment
Stable disease for 9 cycles is defined as proportion of patients whose stable disease last for at least 9 cycles.
Outcome measures
| Measure |
Treatment (Sintilimab)
n=6 Participants
Participants receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Stable Disease for 9 Cycles
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
SECONDARY outcome
Timeframe: Up to 90 days after the last dose, approximately 34 monthsAdverse events were evaluated according to NCI CTCAT v5.0
Outcome measures
| Measure |
Treatment (Sintilimab)
n=6 Participants
Participants receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Adverse Events
Overall Treatment-emergent adverse events
|
6 Participants
|
|
Adverse Events
Treatment-related adverse events
|
5 Participants
|
Adverse Events
Treatment (Sintilimab)
Serious adverse events
| Measure |
Treatment (Sintilimab)
n=6 participants at risk
Participants receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Spinal Fracture, Grad 3,
|
16.7%
1/6 • Up to 3 years
|
|
Blood and lymphatic system disorders
Device related infection, Grad 3
|
16.7%
1/6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea, Grad 3,
|
16.7%
1/6 • Up to 3 years
|
Other adverse events
| Measure |
Treatment (Sintilimab)
n=6 participants at risk
Participants receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
General disorders
Flu like symptoms Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
Investigations
Hypoalbuminemia Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
Hypothyroidism
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
|
General disorders
Hypothyroidism Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Tonsilitis
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
COVID-19 Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
Insomnia Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Left hip/Left Leg Discomfort
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
L shoulder/LUE Discomfort
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 3 • Up to 3 years
|
|
Investigations
Neutrophil Count Decreased Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
Non-Cardiac Chest Pain
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Pain In the Mouth
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Left Knee Pain
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Investigations
Platelet Count Decreased
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
|
Renal and urinary disorders
Abnormal Urinalysis
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Investigations
Serum Amylase Increased
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Investigations
Serum Amylase Increased Grade 3
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin Lesion R Calf Discomfort
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin Rash to the Left Index Finger
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Spinal Fracture Grade 3
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Investigations
TSH Increased
|
33.3%
2/6 • Number of events 5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection Grade 3
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
Urinary Tract Infection Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Weight Loss
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Investigations
WBC Decreased
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea Grade 2
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea Grade 3
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
Ear Pain
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Epstein-Barr Virus
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
Eye Disorders- Other, specify
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
Fatigue
|
83.3%
5/6 • Number of events 8 • Up to 3 years
|
|
Investigations
Blood Bilirubin Increased Grade 2
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Chest Tightness
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Cardiac disorders
Increase in QTc Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
General disorders
Fatigue Grade 2
|
66.7%
4/6 • Number of events 4 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Investigations
Creatinine Increased
|
50.0%
3/6 • Number of events 9 • Up to 3 years
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
|
Investigations
Creatinine Increased Grade 2
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 5 • Up to 3 years
|
|
Investigations
Alanine Aminotransferase Increased
|
33.3%
2/6 • Number of events 4 • Up to 3 years
|
|
General disorders
Allergic Reaction Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Number of events 3 • Up to 3 years
|
|
Blood and lymphatic system disorders
Anemia Grade 2
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
3/6 • Number of events 4 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia Grade 3
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Investigations
Blood Bilirubin Increased
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
Additional Information
Vinod Ravi, MD
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place