Adriamycin and Ifosfamide Combined With Sintilimab

Sponsor
Sun Yat-sen University
Study ID
NCT04589754
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

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

Interventions

  • Sintilimab plus chemotherapy — DRUG
    AI regimen chemotherapy (ADM 50 mg / m2, D1 + IFO 2.5 g / m2, D1-3, IV drip) was used for 3 weeks; CAV / IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg / m2 D1 + VCR 1.4mg/m2 D1 and regimen 2: IFO 1.5g/m2 D1-5 + VP-16 100mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks; sintilimab (10ml; 100mg) was administered intravenously every 3 weeks.
  • Adriamycin-based chemotherapy — DRUG
    AI regimen chemotherapy (ADM 50 mg / m2, D1 + IFO 2.5 g / m2, D1-3, IV drip) was used for 3 weeks; CAV / IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg / m2 D1 + VCR 1.4mg/m2 D1 and regimen 2: IFO 1.5g/m2 D1-5 + VP-16 100mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks.

Study Details

The aim of this study was to explore the efficacy and safety of adriamycin and ifosfamide combined with sintilimab versus chemotherapy in the treatment of advanced or unresectable soft tissue sarcoma.

Key Dates

First listed
Oct 19, 2020
Start date
Jul 26, 2021
Status verified
Dec 2023
Primary completion
Dec 30, 2025
Completion
Jul 30, 2026

Study Design

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

Arms

  • Experimental: Sintilimab plus chemotherapy
    Adriamycin and ifosfamide combined with sintilimab in the treatment of advanced or unresectable soft tissue sarcoma
  • Placebo Comparator: Adriamycin-based chemotherapy
    Adriamycin-based chemotherapy in the treatment of advanced or unresectable soft tissue sarcoma

Primary Outcome Measure

Overall response rate, ORR [ Time Frame: up to 24 months ]

Central Contacts

Related Studies