A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03092895
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Biliary Tract Carcinoma
  • Advanced Primary Liver Cancer

Eligibility Criteria

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

Interventions

  • SHR-1210 — BIOLOGICAL
    Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
  • Apatinib — DRUG
    Subjects receive Apatinib orally every day with a dose escalation
  • FOLFOX4 — DRUG
    Subjects receive FOLFOX4 treatment every 2 weeks
  • GEMOX — DRUG
    Subjects receive GEMOX treatment every 2 weeks

Study Details

This an open-label，Non-Randominzed Phase 2 study to evaluate the Safety and Tolerability of SHR-1210 in combination with Apatinib or chemotherapy (FOLFOX4 or GEMOX regimen) in subjects with Advanced PLC.or BTC Participants with advanced PLC who failed or intolerable to prior systemic therapy will be treated with SHR-1210 plus Apatinib; Participants with advanced PLC or BTC who have never received prior systemic therapy will be treated with SHR-1210 plus FOLFOX4 or GEMOX regimen.

Key Dates

Start date
Apr 24, 2017
Status verified
Apr 2022
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021

Study Design

Enrollment
157 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-1210+Apatinib(Arm A）
  • Experimental: SHR-1210+FOLFOX4 or GEMOX regimen(Arm B）

Primary Outcome Measure

The Safety and Tolerability [ Time Frame: Up to approximately 4 years ]

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