Sintilimab for Angiosarcoma

Recruiting in Palo Alto (17 mi)

Overseen byVinod Ravi, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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.

+14 more

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.

+28 more

Participant Groups

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.

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.