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 range
18 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.