The Combination of Sintilimab and AI (Doxorubicin, ADM/Ifosfamide, IFO) for the First Line Treatm… (NCT04356872) | Clinical Trial Compass
UnknownPhase 2
The Combination of Sintilimab and AI (Doxorubicin, ADM/Ifosfamide, IFO) for the First Line Treatment of Select Type of Metastatic/Unresectable Soft Tissue Sarcoma
China45 participantsStarted 2020-04-08
Plain-language summary
This is a phase II trial to explore the feasibility of PD-1 immune check point inhibitor, sintilimab, in combination of stand of care chemotherapy in first-line treatment of selected soft tissue sarcoma.
Who can participate
Age range
18 Years – 75 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:
* Men and women aged 18-75 years;
* Provide written informed consent;
* Local advanced or metastatic unresectable sarcoma;
* Histologically confirmed undifferentiated pleomorphic sarcoma, synovial sarcoma, de-differentiated liposarcoma and myxoid liposarcoma;
* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale;
* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
* Life span expectation over 3 months
* Absolute neutrophil count (ANC) ≥1,500/mcL (within 7 days of treatment initiation) ；
* Hemoglobin ≥9 g/dL (within 7 days of treatment initiation) ；
* Platelets ≥ 90,000/mcL (within 7 days of treatment initiation) ；
* Serum creatinine ≤ 1.5 X upper limit of normal (ULN) or creatinine clearance \[CrCl\]) ≥ 50 mL/min for subject with creatinine levels (within 7 days of treatment initiation) ；
* Serum total bilirubin ≤ 1.5 X ULN (within 7 days of treatment initiation) ；
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 X ULN or =\< 5 X ULN for subjects with liver metastases (within 7 days of treatment initiation)；
Exclusion Criteria:
* Prior systemic therapy for advanced and metastatic disease, except adjuvant treatment（not received anthracycline）replase over 6 months;
* Received any testing anti-cancer drugs within four weeks of treatment initiation…
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.