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

NCT05198609 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2026-01-21

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

  • First People's Hospital of Foshan

    collaborator OTHER

  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER

  • Affiliated Hospital of Guangdong Medical University

    collaborator OTHER

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-17
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05198609 on ClinicalTrials.gov