RecruitingPhase 2NCT07100392

Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab

Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab: A Randomized, Phase 2 Study.


Sponsor

Fudan University

Enrollment

141 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — TUDCA (a bile acid supplement), camrelizumab (an immunotherapy drug), and regorafenib (a targeted therapy) — for people with advanced liver cancer (hepatocellular carcinoma) that got worse after prior treatment with immunotherapy plus bevacizumab. **You may be eligible if...** - You are 18 or older - You have confirmed advanced liver cancer that cannot be surgically removed - Your cancer progressed after treatment with a PD-1/PD-L1 inhibitor plus bevacizumab - You have at least one measurable tumor - Your liver is functioning reasonably well (Child-Pugh 5–7) - If you have hepatitis B, your viral load is under control with antiviral medication - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - You have had a liver transplant or are on a waiting list - You have significant heart disease or history of serious bleeding in the past 4 weeks - You have had a stroke, deep vein clot, or pulmonary embolism in the past 6 months - You have active HIV - You are pregnant or breastfeeding - You have active autoimmune disease requiring systemic treatment - You have interstitial lung disease (lung scarring) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtauroursodeoxycholic 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.

DRUGCamrelizumab

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.

DRUGRegorafenib

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.


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT07100392


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