drugset / Trial / NCT04718909
Regorafenib Plus Sintilimab vs. Regorafenib as the Second-line Treatment for HCC
Phase 2
Unknown
166 enrolled
Second Affiliated Hospital of Guangzhou Medical University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University · collabCancer Hospital of Guangxi Medical University · collabCancer Institute and Hospital, Chinese Academy of Medical Sciences · collabFifth Affiliated Hospital, Sun Yat-Sen University · collabFirst People's Hospital of Zhaoqing · collabJiangmen Central Hospital · collabJieyang People's Hospital · collabPeking University Shenzhen Hospital · collabSecond Affiliated Hospital of Nanchang University · collabShantou Central Hospital · collabShenzhen People's Hospital · collabThird Affiliated Hospital, Sun Yat-Sen University · collabYuebei People's Hospital · collabZhaoqing Gaoyao People's Hospital · collabZhuHai Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is conducted to evaluate the efficacy and safety of regorafenib plus sintilimab compared with regorafenib alone as the second-line treatment for patients with unresectable hepatocellullar carcinoma (HCC).
Timeline
- Start
- 2021-01-09
- Primary completion
- 2023-07-08
- Completion
- 2023-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Regorafenib | Small molecule | 160 mg | Oral |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |