Sintilimab for the Treatment of Locally Advanced, Metastatic, or Recurrent Angiosarcoma, the SiARa Cancer Study

Stopped early · Phase 2

Conditions studied: Locally Advanced Angiosarcoma, Metastatic Angiosarcoma, Recurrent Angiosarcoma

In brief

This phase II trial evaluates the effect of sintilimab in treating patients with angiosarcoma that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other places in the body (metastatic), or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sintilimab may help to control angiosarcoma.

Key facts

Study ID

NCT05026736

Run by

M.D. Anderson Cancer Center

People needed

6

Starts

2021-08-23

Expected to finish

2025-08-12

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histopathologically confirmed unresectable, locally advanced, recurrent or metastatic angiosarcoma
• Intolerant to or progressed on at least one line of systemic chemotherapy. Patient ineligible for cytotoxic chemotherapy are eligible
• Aged >= 18
• Can provide archival or fresh tissues for optional correlative analysis
• Have at least one measurable lesion as per RECIST version (v)1.1
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1
• Absolute neutrophil count (ANC) >= 1.0 x 10\^9/L
• Platelet (PLT) count >= 75 x 10\^9/L
• Hemoglobin (HGB) >= 8.0 g/dL
• Total bilirubin (TBIL) =< 1.5 x upper limit of normal (ULN)
• 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
• Urine protein < 2+ from random sample or < 1 g from 24-hour urine collection
• Serum creatinine =< 1.5 x ULN or calculated creatinine clearance rate (Ccr) >= 50 mL/min by Cockcroft-Gault formula
• Adequate coagulation function, defined as international normalized ratio (INR) =< 1.5 or prothrombin time (PT) =< 1.5 x ULN; if the subject is receiving anticoagulant therapy, the results of coagulation tests need to be within the acceptable range for anticoagulants
• Expected survival >= 12 weeks
• Subject (female subjects of childbearing age or male subjects whose partners are of childbearing age) must take effective contraceptive measures during the entire course of the trial and until 180 days after the last dose
• Signed the informed consent form (ICF) and be able to comply with the scheduled follow-up visits and related procedures required in the protocol

You may not qualify if…

• 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
• Enrolled in another interventional clinical study for angiosarcoma, unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study
• Received palliative radiation therapy for local lesion within 2 weeks prior to the first dose
• Received systemic treatment with anti-cancer indications or immunomodulators (including thymosins, interferons, and interleukins) within 2 weeks prior to the first dose of study treatment
• Received systemic immunosuppressants within 2 weeks prior to first dose, excluding local use of glucocorticoids administered by nasal, inhaled, or other routes, and systemic glucocorticoids at physiological doses (no more than 10 mg/day of prednisone or equivalents), or glucocorticoids to prevent allergies to contrast media
• Received a live attenuated vaccine within 4 weeks prior to the first dose of study treatment or be scheduled to receive live attenuated vaccine during the study period
• Note: Seasonal inactivated influenza virus vaccines within 4 weeks prior to the first dose of study treatment are permitted, but attenuated influenza vaccines are not
• Received major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment or is scheduled to receive major surgery during the course of the trial
• Any toxicity (excluding alopecia, events that are not clinically significant, or asymptomatic laboratory abnormalities) due to prior anti-tumor therapy that has not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 grade 0 or 1 prior to the first dose of study treatment
• Known symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis. Subjects with brain metastases who have received prior treatment can be enrolled if the disease is stable (no imaging evidence of progressive disease [PD] for at least 4 weeks prior to the first dose of study treatment), there is no evidence of new brain metastases or progression of the existing metastatic lesion(s) upon repeated imaging, and corticosteroids have not been required for at least 14 days prior to the first dose of study treatment. Patients with carcinomatous meningitis are ineligible, regardless of whether the disease is clinically stable or not
• Subjects with bone metastases at risk of paraplegia
• Known active autoimmune disease requiring treatment or previous disease history within 2 years (subjects with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment, hypothyroidism only requiring thyroid replacement, or type I diabetes only requiring insulin can be enrolled)
• Known history of primary immunodeficiency diseases
• Known active pulmonary tuberculosis
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
• Human immunodeficiency virus (HIV)-infected subjects (positive anti-HIV antibody)
• Active or poorly controlled serious infections that require systemic therapy
• Symptomatic congestive heart failure (New York Heart Association [NYHA] class II-IV) or symptomatic or poorly controlled arrhythmia
• Uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) despite of standard treatment
• Any arterial thromboembolic event within 6 months prior to enrollment, including myocardial infarction, unstable angina, cerebrovascular accident, or transient cerebral ischemic attack
• Significant malnutrition, such as those requiring continuous parenteral nutrition >= 7 days; excluding those having received intravenous treatment for malnutrition for more than 4 weeks before the first dose of study treatment
• History of clinically significant deep venous thrombosis, pulmonary embolism, or other serious thromboembolic events within 3 months prior to enrollment (implantable port or catheter-related thrombosis or incidental pulmonary embolism [PE] detected on scan without symptoms or superficial venous thrombosis are not considered as "serious" thromboembolisms)
• Uncontrolled metabolic disorders, non-malignant organ or systemic diseases, or cancer-related secondary diseases that may lead to higher medical risks and/or survival evaluation uncertainties
• Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis with Child-Pugh class B or C
• Bowel obstruction or history of the following diseases: inflammatory bowel disease, extensive bowel resection (partial colectomy or extensive small intestine resection accompanied with chronic diarrhea), Crohn's disease, or ulcerative colitis

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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