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

NCT03092895 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2026-01-29

Study results available
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Summary

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.

Conditions

  • Advanced Primary Liver Cancer
  • Advanced Biliary Tract Carcinoma

Interventions

BIOLOGICAL

SHR-1210

Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

DRUG

Apatinib

Subjects receive Apatinib orally every day with a dose escalation

DRUG

FOLFOX4

Subjects receive FOLFOX4 treatment every 2 weeks

DRUG

GEMOX

Subjects receive GEMOX treatment every 2 weeks

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03092895 on ClinicalTrials.gov