HAIC Combined With Camrelizumab Plus Rivoceranib for Advanced Mixed Hepatocellular-cholangiocarcinoma (HCC-CCA)

Sponsor
Fudan University
Study ID
NCT07105748
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mixed Hepatocellular-cholangiocarcinoma

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    Camrelizumab will be administered by IV, 200 mg every 2 weeks.
  • Rivoceranib (Apatinib) — DRUG
    Rivoceranib will be administered by oral 250 mg once daily.
  • HAIC — PROCEDURE
    FOLFOX regimen (oxaliplatin, 85 mg/m2 from hour 0-2 on day 1; leucovorin, 400 mg/m2 from hour 2-3 on day 1; and fluorouracil, 400 mg/m2 bolus at hour 3 on day 1 and 2,400 mg/m2 over 24 hours) via infusion via the hepatic artery. HAIC was repeated once every 4 weeks for up to 6 cycles. Camrelizumab plus rivoceranib will be administered 1-3 days after HAIC.

Study Details

To evaluate HAIC combined with Camrelizumab plus rivoceranib for advanced mixed hepatocellular-cholangiocarcinoma (HCC-CCA).

Key Dates

Start date
Aug 15, 2025
Status verified
Aug 2025
Primary completion
Aug 1, 2027
Completion
Aug 1, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HAIC+Camrelizumab+rivoceranib

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