OncoMatch/Clinical Trials/NCT04589741
Toripalimab Combined With CAV/IE Regimen
Is NCT04589741 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Sarcoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT04589741 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 therapy, systemic anti-tumor therapy, radiation therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger and at least 14 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages