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Monoclonal Antibodies

Sintilimab for Angiosarcoma

Phase 2
Waitlist Available
Led By Vinod Ravi
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histopathologically confirmed unresectable, locally advanced, recurrent or metastatic angiosarcoma
Aged >= 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing sintilimab as a treatment for angiosarcoma. Sintilimab is an immunotherapy that may help the body's immune system attack the cancer.

Who is the study for?
Adults with advanced, metastatic, or recurrent angiosarcoma who have tried at least one chemotherapy and can't undergo more. They must be in relatively good health (ECOG <=1), have a measurable cancer lesion, expected to live at least 12 weeks, and agree to use effective contraception. Excluded are those previously treated with certain immunotherapies or suffering from conditions that could interfere with the trial.Check my eligibility
What is being tested?
The SiARa study is testing Sintilimab's effectiveness on angiosarcoma that has spread or returned after treatment. This phase II trial aims to see if this monoclonal antibody can help the immune system fight cancer by stopping tumor growth and spread.See study design
What are the potential side effects?
Sintilimab may cause immune-related side effects such as inflammation of organs, infusion reactions similar to allergic responses, fatigue, digestive issues like diarrhea or constipation, blood disorders including anemia or clotting problems, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My angiosarcoma cannot be removed by surgery and has spread.
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I am 18 years old or older.
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I am fully active and can carry on all pre-disease activities without restriction.
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My angiosarcoma cannot be removed by surgery and has spread.
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I've had a bad reaction or my cancer got worse after chemotherapy.
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I am 18 years old or older.
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I can provide tissue samples for additional tests.
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I am fully active and can carry on all pre-disease activities without restriction.
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My liver function tests are within the required limits.
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My kidney function is within the required range.
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My blood clotting ability is within the normal range, even if I'm on blood thinners.
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I am using effective birth control and will continue for 6 months after the trial ends.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free rate
Secondary outcome measures
Duration of response
Incidence of adverse events (AEs)
Objective response rate (complete response + partial response)
+3 more

Side effects data

From 2023 Phase 3 trial • 397 Patients • NCT03607539
74%
Anaemia
71%
Neutrophil count decreased
68%
White blood cell count decreased
42%
Platelet count decreased
41%
Aspartate aminotransferase increased
41%
Nausea
41%
Alanine aminotransferase increased
38%
Decreased appetite
33%
Asthenia
29%
Vomiting
27%
Constipation
21%
Pyrexia
20%
Hypoalbuminaemia
14%
Rash
13%
Lymphocyte count decreased
13%
Diarrhoea
12%
Cough
12%
Gamma-glutamyltransferase increased
11%
Insomnia
11%
Hypothyroidism
11%
Hypokalaemia
11%
Hyponatraemia
11%
Proteinuria
11%
Dizziness
10%
Upper respiratory tract infection
10%
Blood glucose increased
9%
Weight increased
8%
Pneumonia
8%
Amylase increased
8%
Blood creatinine increased
8%
Weight decreased
8%
Oedema peripheral
8%
Hypophagia
8%
Hepatic function abnormal
7%
Productive cough
7%
Abdominal distension
6%
Haemoglobin decreased
6%
Blood thyroid stimulating hormone increased
6%
Chest discomfort
6%
Hiccups
6%
Hyperthyroidism
6%
Blood alkaline phosphatase increased
6%
Hypoproteinaemia
6%
Hyperglycaemia
6%
Headache
5%
Tachypnoea
5%
Urinary tract infection
5%
Hypercholesterolaemia
5%
Haematuria
5%
Hypertriglyceridaemia
5%
Dyspnoea
5%
Hypoaesthesia
5%
Back pain
5%
Hypertension
4%
Haemoptysis
4%
Pain in extremity
2%
Pneumonitis
2%
Immune-mediated pneumonitis
1%
Respiratory failure
1%
Thrombocytopenia
1%
Abdominal pain
1%
Upper gastrointestinal haemorrhage
1%
Pleural effusion
1%
Interstitial lung disease
1%
Atrial fibrillation
1%
Cardiac failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sintilimab Combination
Placebo Combination

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (sintilimab)Experimental Treatment2 Interventions
Patients receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue to receive treatment at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sintilimab
2019
Completed Phase 3
~3450

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,939 Previous Clinical Trials
1,774,087 Total Patients Enrolled
Vinod RaviPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

Sintilimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05026736 — Phase 2
Angiosarcoma Research Study Groups: Treatment (sintilimab)
Angiosarcoma Clinical Trial 2023: Sintilimab Highlights & Side Effects. Trial Name: NCT05026736 — Phase 2
Sintilimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05026736 — Phase 2
Angiosarcoma Patient Testimony for trial: Trial Name: NCT05026736 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety measures are in place for individuals receiving Sintilimab treatments?

"Although there is limited evidence of Sintilimab's efficacy, the safety data available has enabled our team to assign it a score of 2 according to Power."

Answered by AI

Is enrollment still open for this research experiment?

"Affirmative. According to the clinicaltrials.gov listing, this trial is currently recruiting individuals who meet its criteria; it was initially posted on August 23rd 2021 and updated most recently in July of 2022. 30 enrollees are sought from one medical centre."

Answered by AI

How many participants is this trial recruiting?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, first published on August 23rd 2021 is actively seeking participants. Approximately 30 individuals must be recruited from one medical centre."

Answered by AI

Does this therapeutic trial bring something new to medicine?

"Since Innovent Biologics (Suzhou) Co. Ltd.'s 2017 Phase 3 trial for Sintilimab, which included 290 research participants, the drug has seen active studies conducted in 86 cities and 10 countries - 136 of them being ongoing as of today. Of these experiments, 132 have already been completed to date."

Answered by AI

Could you enumerate the previous experiments conducted involving Sintilimab?

"Presently, over a hundred clinical studies are underway for Sintilimab with 15 of those in the last stages of their research. Most trials take place in Beijing; however, there exists 228 trial locations across the world."

Answered by AI

Who else is applying?

What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
Colorado
How many prior treatments have patients received?
2

What questions have other patients asked about this trial?

How long would I need to be available in Houston?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I am on second chemotherapy formula with only a predicted 20% probability that it can help. I have really wanted to try an immunotherapy approach and would be thrilled if I could contribute, in some small way, to a new alternative for angiosarcoma patients.
PatientReceived 1 prior treatment
~4 spots leftby Dec 2027