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OncoMatch/Clinical Trials/NCT04589741

Toripalimab Combined With CAV/IE Regimen

Is NCT04589741 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Toripalimab Combined With CAV/IE chemotherapy and CAV/IE alternate chemotherapy for soft tissue sarcoma.

Phase 2RecruitingSun Yat-sen UniversityNCT04589741Data as of May 2026

Treatment: Toripalimab Combined With CAV/IE chemotherapy · CAV/IE alternate chemotherapyThe aim of this study was to investigate the efficacy and safety of CAV/IE chemotherapy combined with toripalimab versus CAV/IE chemotherapy alone in the treatment of patients with advanced or unresectable bone and soft tissue sarcomas who failed in standard treatment.

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Extracted eligibility criteria

Cancer type

Sarcoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard treatment

the standard treatment failed or there was no standard treatment

Cannot have received: anti-PD-1 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: radiation therapy

Over extended field radiotherapy was performed within 4 weeks before admission or limited field radiotherapy was performed within 2 weeks before grouping

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; ALT and AST ≤ 5x ULN with liver metastasis

Cardiac function

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

Blood routine examination standard ... Hemoglobin (HB) ≥ 90g / L; ANC ≥ 1.5 × 10^9 / L; Platelet (PLT) ≥ 80 × 10^9 / L. ... Total bilirubin (TBIL) ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN; ALT and AST ≤ 5x ULN with liver metastasis ... Serum creatinine (CR) ≤ 1.5x ULN or creatinine clearance rate (CCR) ≥ 60ml / min ... Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value (50%).

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

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