Sintilimab for the Treatment of Locally Advanced, Metastatic, or Recurrent Angiosarcoma, the SiAR… (NCT05026736) | Clinical Trial Compass
TerminatedPhase 2
Sintilimab for the Treatment of Locally Advanced, Metastatic, or Recurrent Angiosarcoma, the SiARa Cancer Study
Stopped: PI request, \<75% participation
United States6 participantsStarted 2021-08-23
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 childbear…