Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab
NCT07100392 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141
Last updated 2025-08-17
Summary
To evaluate the efficacy and safety of Tauroursodeoxycholic Acid (TUDCA) plus Camrelizumab and Regorafenib for patients with advanced hepatocellular carcinoma (HCC) who have progressed on prior systemic treatment with Anti-PD1/PD-L1 plus bevacizumab combination.
Conditions
- Hepatocellular Carcinoma (HCC)
Interventions
- DRUG
-
tauroursodeoxycholic acid (TUDCA)
TUDCA (250 mg, twice daily) will be administered orally until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- DRUG
-
Camrelizumab
Camrelizumab will be administered by IV, 200 mg on day 1 of each 14 day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- DRUG
-
Regorafenib 80 mg was given orally once daily on days 1-21 of a 28-day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Sponsors & Collaborators
-
Fudan University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-14
- Primary Completion
- 2027-08-01
- Completion
- 2028-08-01
Countries
- China
Study Locations
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