What side effects are associated with this type of intervention?

Treatments for angiosarcoma similar to Sintilimab, which are monoclonal antibodies and immune checkpoint inhibitors, commonly cause immune-related adverse events (irAEs) such as skin rash, colitis, hepatitis, thyroid dysfunction, and pneumonitis. Severe side effects can include myocarditis and neurological toxicities. Other common side effects include fatigue, fever, and infusion-related reactions.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for angiosarcoma that are directly comparable to sintilimab. However, immunotherapy drugs such as pembrolizumab and nivolumab, which are monoclonal antibodies targeting the PD-1/PD-L1 pathway, have been approved for various cancers and work by enhancing the immune system's ability to attack cancer cells. These drugs are similar in mechanism to sintilimab and represent a broader category of treatments that interfere with tumor cell growth and spread by modulating the immune response.

What other types of research exist?

Promising alternatives to Sintilimab for Angiosarcoma patients include Pembrolizumab and Nivolumab, both of which are monoclonal antibodies that have shown efficacy in various cancers by enhancing the immune system's attack on tumor cells. Additionally, Avelumab and Durvalumab are other potential options, given their similar mechanisms of action and ongoing research in different cancer types.

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Monoclonal Antibodies

Sintilimab for Angiosarcoma

Q: What is the mechanism of action of this treatment?

Common treatments for angiosarcoma, such as the monoclonal antibody sintilimab, work by enhancing the immune system's ability to attack cancer cells and by interfering with the growth and spread of tumors. These mechanisms are particularly important for angiosarcoma patients because the disease is typically aggressive and resistant to standard treatments. By leveraging the body's own immune response, these therapies offer a promising approach to controlling the disease and improving patient outcomes.

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

Serum creatinine =< 1.5 x ULN or calculated creatinine clearance rate (Ccr) >= 50 mL/min by Cockcroft-Gault formula

Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN in subjects without hepatic metastasis; ALT and AST =< 5 x ULN in subjects with hepatic metastasis, gamma-glutamyl transferase (GGT) =< 10 x ULN

Must not have

Received treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug that specifically targets T-cell co-stimulation or immune checkpoint pathways

Subjects with bone metastases at risk of paraplegia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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 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.

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.

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 kidney function is within the required range.

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My liver function tests are within the required limits.

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My angiosarcoma cannot be removed by surgery and has spread.

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I am fully active and can carry on all pre-disease activities without restriction.

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My blood clotting ability is within the normal range, even if I'm on blood thinners.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with specific drugs that target the immune system.

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My cancer has spread to my bones, risking paralysis.

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I have a known history of primary immunodeficiency.

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I have active tuberculosis in my lungs.

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I do not have any serious infections that need treatment.

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My high blood pressure is not controlled even with treatment.

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I haven't had any serious GI issues like perforation or abnormal connections within the last 6 months, except for procedures like gastrostomy.

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I am taking corticosteroids for my lung condition.

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I have had an organ or stem cell transplant from another person.

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I have severe liver issues like cirrhosis or hepatic encephalopathy.

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I have heart failure symptoms or uncontrolled heart rhythm problems.

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I am currently pregnant or breastfeeding.

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I do not have a current bowel blockage or a history of major bowel diseases or surgeries.

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I have active hepatitis B or C with specific viral load levels.

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I had radiation for symptom relief on a specific area within the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free rate

Secondary study objectives

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

Weight increased

Pneumonia

Amylase increased

Blood creatinine increased

Weight decreased

Oedema peripheral

Hypophagia

Hepatic function abnormal

Abdominal distension

Productive cough

Haemoglobin decreased

Blood thyroid stimulating hormone increased

Chest discomfort

Hiccups

Hyperthyroidism

Blood alkaline phosphatase increased

Hypoproteinaemia

Hyperglycaemia

Headache

Tachypnoea

Urinary tract infection

Hypertriglyceridaemia

Hypercholesterolaemia

Haematuria

Dyspnoea

Hypoaesthesia

Back pain

Hypertension

Haemoptysis

Pain in extremity

Immune-mediated pneumonitis

Pneumonitis

Respiratory failure

Thrombocytopenia

Abdominal pain

Upper gastrointestinal haemorrhage

Pleural effusion

Interstitial lung disease

Atrial fibrillation

Cardiac failure

100%

80%

60%

40%

20%

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

2021

Completed Phase 3

~3370

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for angiosarcoma, such as the monoclonal antibody sintilimab, work by enhancing the immune system's ability to attack cancer cells and by interfering with the growth and spread of tumors. These mechanisms are particularly important for angiosarcoma patients because the disease is typically aggressive and resistant to standard treatments. By leveraging the body's own immune response, these therapies offer a promising approach to controlling the disease and improving patient outcomes.

Anti-angiogenic therapy for high-grade glioma.The medical management of pancreatic cancer: a review.