Infusional FOLFOX Plus Camrelizumab and Apatinib vs HAIC-FOLFOX Plus Camrelizumab and Apatinib for Advanced HCC
NCT06172205 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 262
Last updated 2025-12-03
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
- 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.
Sponsors & Collaborators
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-01
- Primary Completion
- 2028-07-31
- Completion
- 2029-07-31
Countries
- China
Study Locations
More Related Trials
-
HAIC of FOLFOX Plus Sorafenib vs HAIC of FOLFIRINOX Plus Sorafenib for Advcanced HCC
NCT03812783 ·Status: UNKNOWN ·Phase: PHASE2
-
Systemic Chemotherapy With FOLFOX Plus Atezolizumab & Bevacizumab for Patients With Advanced HCC Who Previously Received Atezolizumab & Bevacizumab
NCT07192185 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma
NCT06363825 ·Status: RECRUITING ·Phase: PHASE2
-
Camrelizumab in Combination With Apatinib in Advanced ICC: A Single-arm Phase II Study
NCT04454905 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of the Application of HAIC in Advanced HCC Previously Treated With ICIs and Antiangiogenic Agents
NCT05718492 ·Status: RECRUITING ·Phase: NA
-
A Trial of Hepatic Arterial Infusion Combined With Apatinib and Camrelizumab for C-staged Hepatocellular Carcinoma in BCLC Classification
NCT04191889 ·Status: RECRUITING ·Phase: PHASE2
-
HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC
NCT03468231 ·Status: UNKNOWN ·Phase: PHASE3
-
Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb HCC
NCT05062837 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Evaluation Effectiveness and Safety of (cTACE or DEB-TACE + FOLFOX Regimen HAIC) Combined With Camrelizumab and Apatinib Mesylas in the Treatment of Advanced Hepatocellular Carcinoma
NCT04479527 ·Status: UNKNOWN ·Phase: PHASE2
-
Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE
NCT03722498 ·Status: WITHDRAWN ·Phase: PHASE2
-
Sorafenib Alone Versus Sorafenib Combined With HAIC for Advanced HCC
NCT02774187 ·Status: COMPLETED ·Phase: PHASE3
-
FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial
NCT06201065 ·Status: RECRUITING ·Phase: PHASE3
-
A Single-arm Clinical Study of HAIC Combined With Apatinib and Camrelizumab in the Treatment of Unresectable MTM HCC
NCT05839197 ·Status: RECRUITING ·Phase: PHASE2
-
HAIC Combined With Donafenib Tosilate and Toripalimab for Unresectable HCC
NCT05493332 ·Status: UNKNOWN ·Phase: PHASE2
-
Hepatic Artery Infusion Chemotherapy for Unresectable Hepatocelluar Carcinoma Who Failed to Systemic Therapy
NCT04994236 ·Status: UNKNOWN ·Phase: PHASE2
-
HAIC With One-day FOLFOX vs. HAIC With Two-day FOLFOX for Unresectable HCC: a Non-inferiority Study
NCT05476432 ·Status: RECRUITING ·Phase: PHASE3
-
Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib in Advanced Hepatocellular Carcinoma
NCT03164382 ·Status: COMPLETED ·Phase: PHASE3
-
HAIC Plus A+T for Patients With High-risk HCC: a Single-arm Phase 2 Trial
NCT05886465 ·Status: UNKNOWN ·Phase: PHASE2
-
Hepatic Artery Infusion Chemotherapy Plus Donafenib in Patients With Hepatocellular Carcinoma After Surgery
NCT04962958 ·Status: UNKNOWN ·Phase: PHASE2
-
Phase 2 Study of Sorafenib Plus HAIC of FOLFOX vs. Sorafenib Plus HAIC of OXA for Advanced HCC
NCT03812770 ·Status: UNKNOWN ·Phase: PHASE2
-
HAIC Versus TACE for Large and Unresectable Hepatocellular Carcinoma Staged BCLC A/B
NCT03048123 ·Status: COMPLETED ·Phase: PHASE2
-
Adjuvant Chemotherapy With FOLFOX in HCC Patients After Resection
NCT02738697 ·Status: UNKNOWN ·Phase: PHASE3
-
HAIC Combined Withzoledronic Acid for the Prevention of Bone Metastases in Advanced HCC
NCT05866172 ·Status: UNKNOWN ·Phase: PHASE3
-
A Trial of Conversion Treatment of HAIC Combined With Camrelizumab and Apatinib for Unresected Hepatocellular Carcinoma
NCT05099848 ·Status: COMPLETED ·Phase: PHASE2
-
Transarterial Infusion of PD-1 Antibody Plus TACE-HAIC for Unresectable HCC: a Single-arm, Phase 2 Clinical Trial
NCT04814030 ·Status: UNKNOWN ·Phase: PHASE2