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OncoMatch/Clinical Trials/NCT04589754

Adriamycin and Ifosfamide Combined With Sintilimab

Is NCT04589754 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sintilimab plus chemotherapy and Adriamycin-based chemotherapy for soft tissue sarcoma.

Phase 2RecruitingSun Yat-sen UniversityNCT04589754Data as of May 2026

Treatment: Sintilimab plus chemotherapy · Adriamycin-based chemotherapyThe aim of this study was to explore the efficacy and safety of adriamycin and ifosfamide combined with sintilimab versus chemotherapy in the treatment of advanced or unresectable soft tissue sarcoma.

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Extracted eligibility criteria

Cancer type

Sarcoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: anti-PD-1 therapy

Patients who had previously received anti-PD-1 / PD-L1 antibody therapy

Cannot have received: anti-PD-L1 therapy

Patients who had previously received anti-PD-1 / PD-L1 antibody therapy

Cannot have received: systemic anti-tumor therapy

Systemic anti-tumor therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks prior to the trial drug treatment) was planned within 4 weeks before enrollment or during the study period

Cannot have received: extended field radiotherapy

Over extended field radiotherapy (ef-rt) was performed within 4 weeks before admission

Cannot have received: limited field radiotherapy

limited field radiotherapy (rfrt) was performed within 2 weeks before grouping

Cannot have received: other clinical trial anti-tumor drugs

Patients who participated in other clinical trials of anti-tumor drugs within 28 days before enrollment

Lab requirements

Blood counts

Hemoglobin (HB) ≥ 90g/L; ANC ≥ 1.5 × 10^9/L; Platelet (PLT) ≥ 80 × 10^9/L

Kidney function

Serum creatinine (CR) ≤ 1.5x ULN or creatinine clearance rate (CCR) ≥ 60 ml/min

Liver function

Total bilirubin (TBIL) ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN (≤ 5x ULN with liver metastasis)

Cardiac function

Left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%)

Blood routine examination standard ... Hemoglobin (HB) ≥ 90g / L; The absolute value of neutrophil (ANC) ≥ 1.5 × 109 / L; Platelet (PLT) ≥ 80 × 109 / L. Biochemical examination ... TBIL ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN (≤ 5x ULN with liver metastasis); Serum creatinine (CR) ≤ 1.5x ULN or CCR ≥ 60ml / min; Doppler ultrasound evaluation: LVEF ≥ lower limit of normal value (50%).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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