Trials / Completed
CompletedNCT03092895
A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 157 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-04-24
- Primary completion
- 2021-03-31
- Completion
- 2021-03-31
- First posted
- 2017-03-28
- Last updated
- 2026-01-29
- Results posted
- 2026-01-29
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03092895. Inclusion in this directory is not an endorsement.