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

Sponsor
Fudan University
Study ID
NCT07100392
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tauroursodeoxycholic acid (TUDCA) — DRUG
    TUDCA (250 mg, twice daily) will be administered orally until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
  • Camrelizumab — DRUG
    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.
  • Regorafenib — 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.

Study Details

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.

Key Dates

Start date
Aug 14, 2025
Status verified
Aug 2025
Primary completion
Aug 1, 2027
Completion
Aug 1, 2028

Study Design

Enrollment
141 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TUDCA+Camrelizumab+Regorafenib
    TUDCA+Camrelizumab+Regorafenib
  • Active Comparator: Camrelizumab+Regorafenib
    Camrelizumab+Regorafenib
  • Active Comparator: Regorafenib
    Regorafenib

Primary Outcome Measure

Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [ Time Frame: max 24 months ]

Central Contacts

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