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.
Treatment: Toripalimab Combined With CAV/IE chemotherapy · CAV/IE alternate chemotherapy — The 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.
Check if I qualifyExtracted 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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