NCT04589741

Toripalimab Combined With CAV/IE Regimen

An Open, Multicenter, Randomized, Phase II Study of Toripalimab Combined With CAV/IE Regimen in Patients With Advanced or Unresectable Bone and Soft Tissue Sarcomas Who Failed Standard Treatment

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

At present, there are many clinical trials of chemotherapy drugs combined with anti-PD-1 antibody in the treatment of tumor, but the clinical study of CAV/IE chemotherapy combined with anti-PD-1 antibody in the treatment of advanced or non resectable bone and soft tissue sarcoma has not been started, and the related research is still in the blank state. In view of the above problems, to observe and evaluate the efficacy and safety of CAV/IE chemotherapy combined with toripalimab versus CAV/IE chemotherapy alone in the treatment of advanced or non resectable bone and soft tissue sarcoma patients, so as to provide more treatment options for patients with advanced or non resectable bone and soft tissue sarcoma.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Toripalimab 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 After 6 courses of treatment, patients with disease control (CR + PR + SD) and tolerable adverse reactions were treated continuously. 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.
DRUG	CAV/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.

Timeline

• Start date: 2020-10-23
• Primary completion: 2025-01-30
• Completion: 2026-06-30
• First posted: 2020-10-19
• Last updated: 2024-01-09

Locations

1 site across 1 country: China