Regorafenib Plus Sintilimab vs. Regorafenib as the Second-line Treatment for HCC
NCT04718909 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166
Last updated 2022-11-10
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).
Conditions
- Hepatocellular Carcinoma Non-resectable
Interventions
- DRUG
-
Regorafenib + sintilimab
Regorafenib: 160 mg p.o. qd for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off). Sintilimab: 200mg i.v. q3w.
- DRUG
-
160 mg p.o. qd for 3 weeks of every 4 week cycle.
Sponsors & Collaborators
-
ZhuHai Hospital
collaborator OTHER -
Shenzhen People's Hospital
collaborator OTHER -
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
collaborator OTHER -
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
collaborator OTHER -
Second Affiliated Hospital of Nanchang University
collaborator OTHER -
The First People's Hospital of Zhaoqing
collaborator UNKNOWN -
Fifth Affiliated Hospital, Sun Yat-Sen University
collaborator OTHER -
Cancer Hospital of Guangxi Medical University
collaborator OTHER -
Jiangmen Central Hospital
collaborator OTHER -
Third Affiliated Hospital, Sun Yat-Sen University
collaborator OTHER -
Peking University Shenzhen Hospital
collaborator OTHER -
Jieyang People's Hospital
collaborator OTHER -
Shantou Central Hospital
collaborator OTHER -
Yuebei People's Hospital
collaborator OTHER -
Zhaoqing Gaoyao People's Hospital
collaborator UNKNOWN -
Second Affiliated Hospital of Guangzhou Medical University
lead OTHER
Principal Investigators
-
Kangshun Zhu, Dr. · Second Affiliated Hospital of Guangzhou Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-09
- Primary Completion
- 2023-07-08
- Completion
- 2023-12-31
Countries
- China
Study Locations
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