Sintilimab for Angiosarcoma
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests sintilimab, an immunotherapy drug, in patients with advanced, metastatic, or recurrent angiosarcoma. Sintilimab helps the immune system recognize and attack cancer cells, aiming to control the disease.
Who Is on the Research Team?
Vinod Ravi, M.D.
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
I am using effective birth control and will continue for 6 months after the trial ends.
I've had a bad reaction or my cancer got worse after chemotherapy.
The amount of protein in your urine needs to be low.
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Exclusion Criteria
If unsure about my eligibility, I will contact the sponsor with my full medical history.
I have been treated with specific drugs that target the immune system.
I have been on IV nutrition for less than 4 weeks due to severe malnutrition.
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Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive sintilimab intravenously every 21 days for up to 24 months
24 months
1 visit every 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 years
Follow-up at 30 and 90 days, then every 60 days
What Are the Treatments Tested in This Trial?
Interventions
- Sintilimab
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (sintilimab)Experimental Treatment2 Interventions
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Trials
3,107
Recruited
1,813,000+
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