Study of SHR-1210 Combined With Apatinib in the Treatment of Sarcoma

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT04126993
Phase
PHASE2
Status
Unknown

Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
14 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab, — DRUG
    Camrelizumab+ Apatinib test group: intravenous injection once every three weeks, Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.
  • Apatinib — DRUG
    Apatinib single drug control group: Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.

Study Details

To observe the effectiveness of SHR-1210 (Camrelizumab) combined with apatinib in the treatment of unresectable sarcoma patients with chemotherapy failure. The main observations were progression-free survival (PFS) and progression-free control rate (PFR), followed by objective response rate (ORR) (CR+PR), disease control rate (DCR) (CR+PR+SD), and overall survival (OS). To observe the safety of SHR-1210 (Camrelizumab) combined with apatinib in the treatment of sarcoma

Key Dates

Start date
Jun 1, 2019
Status verified
Sep 2019
Primary completion
Dec 31, 2019
Completion
Dec 31, 2020

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab+ Apatinib test group
    Camrelizumab intravenous injection once every three weeks, Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.
  • Active Comparator: Apatinib single drug control group
    Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Within 2 years ]

Central Contacts

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