NCT05412589

mFOLFOX7 Plus Camrelizumab and Apatinib for Advanced HCC

Intravenous mFOLFOX7 Plus Camrelizumab and Apatinib for CNLC Stage III Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (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 prospective, one-arm, phase II clinical study of intravenous mFOLFOX6 plus Camrelizumab combined with apatinib for CNLC stage III hepatocellular carcinoma

Detailed description

The combination of anti-angiogenesis and immune checkpoint blockade showed promising outcomes for advanced HCC. Hepatic artery infusion chemotherapy （HAIC） combined with apatinib and camrelizumab could augment treatment efficacy in preliminary study. But HAIC had disadvantages such as technical limitations, expensive cost and poor patient comfort. In the present study, we aimed to investigate the efficacy and safety of Venous Infusion Chemotherapy（VIC） plus camrelizumab and apatinib for CNLC stage Ⅲ HCC.

Conditions

• Stage III Hepatocellular Cancer (CNLC Staging)

Interventions

Type	Name	Description
DRUG	mFOLFOX7+Camrelizumab+Apatinib	Drug: Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Drug: Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle. Drug: Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle. Drug: Camrelizumab 200mg infusion on D1 for every 21 days Drug: Apatinib 250mg，po，qd for every 21 days

Timeline

• Start date: 2022-06-10
• Primary completion: 2025-07-31
• Completion: 2026-07-31
• First posted: 2022-06-09
• Last updated: 2024-07-31

Locations

1 site across 1 country: China