Camrelizumab, Apatinib Plus HAIC Versus Camrelizumab and Apatinib for HCC With Portal Vein Invasion: a Randomized Trial

Sponsor
Sun Yat-sen University
Study ID
NCT05198609
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • FOLFOX-HAIC — PROCEDURE
    Hepatic arterial infusion of oxaliplatin (85mg/m2,IA,day 1, hour 0-2), fluorouracil (400mg/m2,IA,day 1, hour 3), leucovorin (400mg/m2, IV,day 1, hour 2-3) and fluorouracil (2400mg/m2, IA, hour 3-23) repeated every 4 weeks for a total of six times
  • Camrelizumab — DRUG
    Camrelizumab was administered 200mg intravenously for 30-60 minutes every 2 weeks, and the maximum cumulative duration of Camrelizumab is 2 years. The shortest time interval between two administrations should not be less than 12 days.
  • Apatinib — DRUG
    Apatinib was administered orally 250mg once per day

Study Details

Compare the efficacy and safety of camrelizumab, apatinib plus FOLFOX-HAIC and camrelizumab plus apatinib in hepatocellular carcinoma with portal vein invasion.

Key Dates

Start date
Jan 17, 2022
Status verified
Jan 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

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

Arms

  • Experimental: Camrelizumab, Apatinib Plus FOLFOX-HAIC
  • Active Comparator: Camrelizumab and Apatinib

Primary Outcome Measure

Overall survival [ Time Frame: 2 months ]

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