Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC

Sponsor
Linhui Peng
Study ID
NCT07267806
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chemotherapy Effect
  • Hepato Cellular Carcinoma (HCC)

Eligibility Criteria

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

Interventions

  • Infusional mFOLFOX7 plus Camrelizumab and apatinib — DRUG
    Oxaliplatin 85mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on Dand then 2400mg/m2 for 46h of each 21 day cycle. this chemotherapy regimen should be administered for a maximum of 6 cycles. Camrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days.
  • Camrelizumab and apatinib — DRUG
    Camrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days.

Study Details

This is a multi-center randomized phase III clinical study of first-line Camrelizumab and Apatinib with or without intravenous FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma (HCC).

Key Dates

Start date
Oct 31, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2032

Study Design

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

Arms

  • Experimental: Infusional FOLFOX
    Infusional mFOLFOX7 plus Camrelizumab and apatinib
  • Active Comparator: Excluding FOLFOX
    Camrelizumab and Apatinib

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: up to approximately 3 years ]

Central Contacts

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