NCT06172205

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

Infusional FOLFOX Plus Camrelizumab and Apatinib Versus HAIC-FOLFOX Plus Camrelizumab and Apatinib for Hepatocellular Carcinoma of BCLC C Stage: A Multi-center Randomized Phase III Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• BCLC Stage C Hepatocellular Carcinoma
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	intravenous FOLFOX7 plus Camrelizumab and apatinib	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
DRUG	HAIC-FOLFOX plus Camrelizumab and apatinib	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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2028-07-31
• Completion: 2029-07-31
• First posted: 2023-12-15
• Last updated: 2025-12-03

Locations

1 site across 1 country: China