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 range18 Years – 75 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:
* 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…