NCT07100392

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase 2, open-label, randomized, three-arm study designed to evaluate the efficacy and safety of Regorafenib in Combination With Either Camrelizumab monotherapy or Camrelizumab plus Tauroursodeoxycholic Acid (TUDCA) in participants 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

Type	Name	Description
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	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.

Timeline

• Start date: 2025-08-14
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2025-08-03
• Last updated: 2025-08-17

Locations

1 site across 1 country: China