A Study of SHR-1210 Plus Apatinib in Patients With Soft Tissue Sarcoma

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03711279
Phase
PHASE2
Status
Terminated

Conditions

  • Sarcoma

Eligibility Criteria

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

Interventions

  • SHR-1210 plus Apatinib — DRUG
    SHR-1210 200 mg q3w+ Apatinib 500 mg qd
  • ADM plus IFO or IFO alone — DRUG
    ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w；if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used.

Study Details

The main purpose of this study is to evaluate the efficacy of SHR-1210 plus Apatinib versus AMD plus IFO in participants with soft tissue sarcoma.

Key Dates

Start date
Nov 22, 2018
Status verified
Jul 2023
Primary completion
Jun 21, 2021
Completion
Jun 21, 2021

Study Design

Enrollment
99 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-1210 plus Apatinib
  • Active Comparator: ADM plus IFO or IFO alone

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. ]

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