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ACTIVE NOT RECRUITING
NCT05198609
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

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

Official title: Camrelizumab, Apatinib Plus Hepatic Arterial Infusion Chemotherapy Versus Camrelizumab and Apatinib for Hepatocellular Carcinoma With Portal Vein Invasion: a Randomized, Open-label, Multicentre Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2022-01-17

Completion Date

2026-07-01

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

PROCEDURE

FOLFOX-HAIC

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

DRUG

Camrelizumab

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.

DRUG

Apatinib

Apatinib was administered orally 250mg once per day

Locations (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China