Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC

PHASE3RecruitingINTERVENTIONAL
Enrollment

540

Participants

Timeline

Start Date

October 31, 2023

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2030

Conditions
Hepatocellular CarcinomaChemotherapy EffectChemotherapeutic Toxicity
Interventions
DRUG

Oxaliplatin,calcium folinic acid, levofolinic acid, 5-FU

Hepatic arterial infusion chemotherapy with (oxaliplatin 135mg/m2 over 3hrs, calcium folinic acid 400mg/m2 or levofolinic acid 200mg/ m2 over 1.5hrs, 5-FU 400mg/m2 over 2hrs, 5-FU 2400mg/m2 over 46hrs,every 4 weeks)

DRUG

Concurrent Lenvatinib

Lenvatinib 8mg/day combined with the HAIC from the first cycle

DRUG

Concurrent PD-1 antibody

PD-1 antibody which is approved by authorities for HCC treatment combined with the HAIC from the first cycle (dosage and frequency according to instructions)

DRUG

Sequential Lenvatinib

Lenvatinib 8mg/day combined with the HAIC from the third cycle for those patients who do not achieve complete response (CR)

DRUG

Sequential PD-1 antibody

PD-1 antibody which is approved by authorities for HCC treatment combined with the HAIC from the third cycle for those patients who do not achieve complete response (CR) (dosage and frequency according to instructions)

Trial Locations (1)

510060

RECRUITING

SUN Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
collaborator

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

OTHER

collaborator

Affiliated Hospital of Guangdong Medical University

OTHER

collaborator

First People's Hospital of Foshan

OTHER

lead

Sun Yat-sen University

OTHER