Actively Recruiting
Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab
Led by Fudan University · Updated on 2025-08-17
141
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent.
- Age 18 years or older at study entry.
- Diagnosed with locally advanced, metastatic, or unresectable hepatocellular carcinoma confirmed by biopsy or clinical criteria.
- Disease progression after prior treatment with anti-PD1/PD-L1 plus bevacizumab.
- At least one measurable tumor lesion not previously treated or showing progression after prior local therapy.
- Child-Pugh liver score between 5 and 7 and ECOG performance status of 0 to 2.
- If chronic hepatitis B infection is present, viral load must be under 100 IU/mL and on antiviral therapy per guidelines.
- Life expectancy of at least 12 weeks.
- Adequate blood counts and organ function as specified.
- Negative pregnancy test within 7 days before starting trial for women of childbearing potential.
- Willingness and ability to follow study procedures and contraceptive measures throughout the study.
You will not qualify if you...
- Diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Listed for liver transplantation or having advanced liver disease.
- History of cardiac disease or significant gastrointestinal bleeding within 4 weeks before treatment.
- Thrombotic or embolic events within 6 months prior to treatment, except segmental portal vein thrombosis.
- Presence of a second primary cancer, except treated basal skin cancer or cervical carcinoma in situ.
- Immunocompromised status, including HIV infection.
- Participation in another investigational drug study within 30 days or 7 half-lives of prior trial drug.
- Conditions interfering with study evaluation or safety, including interstitial lung disease, HBV/HCV coinfection, pancreatitis, active tuberculosis or other active infections, organ transplant history, immunodeficiency, recent systemic steroids or immunosuppressants, active autoimmune diseases (with exceptions), recent live vaccines, or CNS metastases without meeting specific criteria.
- Use of medications interfering with study drugs.
- Receipt of other cancer treatments except protocol therapy at study start.
- Use of any investigational product within 28 days before study entry.
- Pregnant or breastfeeding women or patients of reproductive potential not using highly effective contraception.
- History of non-compliance or inability to provide informed consent.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
P
Peng Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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