Toripalimab Combined With CAV/IE Regimen

PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

October 23, 2020

Primary Completion Date

January 30, 2025

Study Completion Date

June 30, 2026

Conditions
Soft Tissue Sarcoma
Interventions
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."

Trial Locations (1)

Unknown

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER