Toripalimab Combined With CAV/IE Regimen

Sponsor
Sun Yat-sen University
Study ID
NCT04589741
Phase
PHASE2
Status
Recruiting
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Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
14 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Toripalimab Combined With CAV/IE chemotherapy — DRUG
    CAV/IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg/m2 D1 + VCR 1.4mg/m2 D1 and scheme 2: IFO 1.5g/m2 D1-5 + vp-16 90mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks; The patients were treated with toripalimab (240mg, 6ml) intravenously every 3 weeks; If doxorubicin has reached the upper limit or reduced cardiac toxicity, liposome adriamycin (50mg/m2) or IE regimen can be used For all subjects with disease control (CR+PR+SD), a maximum of 8-10 cycles of treatment is allowed. If doxorubicin reaches the upper limit or to reduce cardiotoxicity, liposomal doxorubicin (35 mg/m² for age ≥60; 40 mg/m² for age \<60) or the IE regimen may be used as an alternative. After completing 8-10 cycles, treatment group subjects with disease control may undergo 1:1 randomization to toripalimab 240 mg IV maintenance or discontinuing treatment until progression or intolerance.
  • CAV/IE alternate chemotherapy — DRUG
    CAV/IE alternate chemotherapy (regimen1: CTX 1.2mg/m2 D1 + ADM 50mg/m2 D1 + VCR 1.4mg/m2 D1 and regimen2: IFO 1.5g/m2 D1-5 + VP-16 90mg/m2 D1-5, IV drip), regimen 1 and 2 were performed alternately, with a cycle of 3 weeks. Patiens with disease control (CR+PR+SD) and tolerable adverse reactions were treated continuously with a maximum of 8-10 cycles. If doxorubicin has reached the upper limit or reduced cardiac toxicity, liposome adriamycin (≥ 60 years old: 35mg/m2, \< 60 year old: 40mg/m2) or IE regimen can be used. The study was completed when the researchers considered that the patients were not suitable for continuous medication or the efficacy evaluation was disease progression (PD). No other anti-tumor treatment can be carried out during the treatment.

Study Details

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.

Key Dates

First listed
Oct 19, 2020
Start date
Oct 23, 2020
Status verified
Jun 2026
Primary completion
Jan 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: toripalimab combined with CAV/IE regimen
    toripalimab combined with CAV/IE regimen in patients with advanced or unresectable bone and soft tissue sarcomas who failed standard treatment
  • Placebo Comparator: CAV/IE chemotherapy alone
    CAV/IE chemotherapy alone in patients with advanced or unresectable bone and soft tissue sarcomas who failed standard treatment

Primary Outcome Measure

Progression-free survival, PFS [ Time Frame: Up to 24 months ]

Central Contacts

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