FOLFOX Plus Lenvatinib Adjuvant Therapy for Hepatocellular Carcinoma Post-Liver Transplantation

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2029

Conditions
Liver CancerLiver Transplant
Interventions
DRUG

FOLFOX4 regimen

FOLFOX4 regimen: Oxaliplatin 85mg/m2 intravenous infusion over 2 hours on Day 1; Leucovorin 400mg/m2 intravenous infusion over 2 hours on Days 1-2; 5-Fluorouracil (5-FU) initially 400mg/m2 intravenous bolus followed by 2400mg/m2 continuous intravenous infusion over 46 hours. Each cycle lasts for 4 weeks, repeated every 4 weeks for a total of 6-8 cycles.

DRUG

lenvatinib

Lenvatinib: For patients with a body weight \<60 kg, the recommended daily dose of lenvatinib is 8 mg (2 capsules of 4 mg each), once daily; for patients with a body weight ≥60 kg, the recommended daily dose of lenvatinib is 12 mg (3 capsules of 4 mg each), once daily. Treatment should be continued until disease progression, intolerable adverse effects, or the end of the study.

Trial Locations (1)

376032

Organ Transplantation Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University,, Guangzhou

All Listed Sponsors
lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER