RecruitingPhase 2NCT04589741

Toripalimab Combined With CAV/IE Regimen

A Multicenter, Randomized, Parallel-controlled Phase II Study of Toripalimab Combined With CAV/IE Regimen Versus Chemotherapy Alone in Patients With Advanced or Unresectable Bone and Soft Tissue Sarcoma Who Have Failed Standard Treatment

Sponsor

Sun Yat-sen University

Enrollment

134 participants

Start Date

Oct 23, 2020

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma

Summary

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.

Eligibility

Min Age: 14 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study combines an immunotherapy drug called toripalimab with two chemotherapy regimens (CAV and IE) for people with advanced or inoperable bone and soft tissue sarcomas (a type of cancer that starts in connective tissues) that have not responded to standard treatment. **You may be eligible if...** - You have an advanced or inoperable soft tissue or bone sarcoma confirmed by biopsy - Standard treatments have failed or there is no standard treatment for your type - You have at least one measurable tumor on imaging - You are between 14 and 70 years old - Your overall health and function level is acceptable **You may NOT be eligible if...** - Your cancer is a type specifically excluded (such as well-differentiated liposarcoma, gastrointestinal stromal tumor, or malignant mesothelioma) - You have no measurable tumor on imaging - Your overall health is too poor to tolerate treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab Combined With CAV/IE chemotherapy

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.

DRUGCAV/IE alternate chemotherapy

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.