Sintilimab for Angiosarcoma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunosuppressants, Immunomodulators

Disqualifiers: Autoimmune, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 31

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of sintilimab in treating angiosarcoma, a rare and aggressive cancer that can spread to nearby tissues, lymph nodes, or other parts of the body. Sintilimab is an immunotherapy treatment that uses monoclonal antibodies to help the immune system target and attack cancer cells, potentially stopping their growth and spread. This study suits individuals with angiosarcoma that cannot be removed by surgery, has returned after treatment, or has spread, and who have tried other chemotherapy options without success. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot have received certain treatments like systemic immunosuppressants or anti-cancer drugs within 2 weeks before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that sintilimab is likely to be safe for humans?

Research has shown that sintilimab has undergone testing in various studies to assess its safety in people. One study found no serious side effects linked to the treatment, indicating good safety. However, another study identified some serious side effects, such as tiredness and low blood cell counts, though these were less common. Previous research indicates that sintilimab is generally well-tolerated, meaning most people can take it without major problems. The treatment has already received approval for other conditions in some regions, suggesting its safety. Overall, sintilimab appears safe for many people, though some may experience side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Sintilimab is unique because it is an immune checkpoint inhibitor specifically targeting the PD-1 protein, which plays a role in preventing the immune system from attacking cancer cells. Unlike traditional treatments for angiosarcoma, which often include chemotherapy and radiation, sintilimab aims to boost the body's natural immune response to fight the cancer. Researchers are particularly excited about sintilimab because it offers a promising new mechanism of action that could potentially improve outcomes for patients with angiosarcoma, a rare and aggressive cancer.

What evidence suggests that sintilimab might be an effective treatment for angiosarcoma?

Research has shown that sintilimab, which participants in this trial will receive, may help treat angiosarcoma. In studies, about 4 out of 10 patients who used sintilimab experienced tumor shrinkage or disappearance. Additionally, the treatment prevented cancer progression in about 7 out of 10 patients. These findings suggest that sintilimab could be a promising option for managing angiosarcoma. ^{1 4 6 7 8}

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.

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.

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?

Group I: Treatment (sintilimab) Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05026736

Study Details | NCT05026736 | Sintilimab for the Treatment ... This phase II trial evaluates the effect of sintilimab in treating patients with angiosarcoma that has spread to nearby tissue or lymph nodes (locally ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9793899/

Efficacy and safety of sintilimab plus doxorubicin in ... Results: A total of 38 patients (20 men and 18 women) were enrolled in this study. The overall ORR was 39.5%, disease control rate was 71.1%, ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)03346-5/pdf

1735P Sintilimab plus anlotinib in patients with advanced ... Conclusions: Despite the failure to meet the predetermined level, Nivolumab exhibited efficacy in a subset of cutaneous angiosarcoma patients refractory to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10850283/

Cadonilimab plus anlotinib effectively relieve rare cardiac ... In the cases of cardiac angiosarcoma (AS) documented here, the combination therapy of cadonilimab and anlotinib produced favorable results.

5. sciencedirect.com sciencedirect.com/science/article/pii/S095980492400844X

The challenge of running trials in advanced angiosarcoma The efficacy in AS was similar to that observed in STS in general with an overall response rate (ORR) of 25 %, m- progression free survival (PFS) of 4.9 months ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11337792/

Real-world efficacy, safety data and predictive clinical ... However, the objective response rate (ORR) ranges only from 5 to 20%, with a poor median progression-free survival (mPFS) of 4.2 months [3].

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10570390/

Safety and clinical efficacy of sintilimab (anti-PD-1) in pediatric ... Sintilimab did not show a dose (1-10 mg/kg)-dependent safety profile. Treatment-related severe adverse events (SAEs) did not occur. Two TRAEs ...

8. spandidos-publications.com spandidos-publications.com/10.3892/ol.2025.14986

Research progress of sintilimab in the treatment of cancer ... The present review provides some data on its long-term effects and safety. For example, in a phase III clinical study in patients with advanced ...