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

StatusRecruiting
PhasePhase 3
Started2023-07-01
View on ClinicalTrials.gov ↗

Amendment history

2025-11-25
Study Status, Oversight, Study Design, Arms and Interventions, Outcome Measures, Eligibility v2
Primary completion date2026-07-31→2028-07-31
Completion date2027-07-31→2029-07-31
Enrollment target192→262
Eligibility criteria+1,768 characters
Inclusion Criteria: Age 18-75, male or female; ECOGThe PSclinical scorediagnosis 0-2;conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to BCLC stage C. Child-pugh liver function grading: Grade A or B The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to BCLC stage C Did not received any type of other first-line drugs such as [...] received radiotherapy, freezing or other local treatments); ECOG PS score 0-2; Expected survival ≥ 12 weeks; The function of vital organs m [...] upper limit of normal value (ULN); Total bilirubin (TBIL) ≤ 1. [...] [...]
Secondary endpoints9 to 12 entries
ORR 9-mon PFSR 18-mon OSR
Primary endpoints1 to 2 entries
ORR6-mon PFSR Hepatic Reserve Function Impairment Rate(ICG-15min)
2025-04-24
Study Status, Oversight v1
Re-verified, no change to tracked fields
2023-12-07
Original filing
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.
Trial Details
NCT Number NCT06172205
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions BCLC Stage C Hepatocellular Carcinoma, Chemotherapy Effect
Enrollment 262 participants
Start Date 2023-07-01
Primary Completion 2028-07-31 (estimated)
Study Completion 2029-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-03