At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study of SHR-1210 (PD-1 Antibody) in Combination With Apatinib or Chemotherapy (FOLFOX4 or GEMOX) in Subjects With Advanced Primary Liver Cancer（PLC）or Biliary Tract Carcinoma (BTC)
In Brief
A Phase 2 clinical trial evaluating SHR-1210, Apatinib, and 2 other interventions for Advanced Primary Liver Cancer and Advanced Biliary Tract Carcinoma. Completed, enrolled 157 participants across 7 sites.
Detailed 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.
Study Details
Timeline
Interventions
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
Subjects receive Apatinib orally every day with a dose escalation
Subjects receive FOLFOX4 treatment every 2 weeks
Subjects receive GEMOX treatment every 2 weeks