Infusional FOLFOX Plus Camrelizumab and Apatinib vs HAIC-FOLFOX Plus Camrelizumab and Apatinib for Advanced HCC

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT06172205
Phase
PHASE3
Status
Recruiting
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Conditions

  • BCLC Stage C Hepatocellular Carcinoma
  • Chemotherapy Effect

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • intravenous FOLFOX7 plus Camrelizumab and apatinib — DRUG
    Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle. Camrelizumab 200mg infusion on D1 for every 21 days Apatinib 250mg，po，qd for every 21 days
  • HAIC-FOLFOX plus Camrelizumab and apatinib — DRUG
    2-h infusion of oxaliplatin at 85 mg/m2 ,a 2-3-h administration of leucovorin at 200 mg/m2 , Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h. Camrelizumab (200 mg intravenously, commencing in 7 days after the first HAIC cycle and repeated every 21 days) and apatinib (250 mg daily, taken orally, beginning in 7 days after the initial HAIC cycle). Camrelizumab 200mg infusion on D1 for every 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 intravenous FOLFOX plus Camrelizumab and apatinib versus HAIC-FOLFOX plus Camrelizumab and apatinib for BCLC C stage hepatocellular carcinoma.

Key Dates

Start date
Jul 1, 2023
Status verified
Nov 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

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

Arms

  • Experimental: Infusional FOLFOX
    Infusional mFOLFOX7 plus Camrelizumab and apatinib
  • Active Comparator: HAIC-FOLFOX
    HAIC-FOLFOX plus Camrelizumab and apatinib

Primary Outcome Measure

6-mon PFSR [ Time Frame: up to approximately 3 years ]

Central Contacts

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