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RECRUITING
NCT06333561

HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.

Official title: Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2021-01-01

Completion Date

2025-12-30

Last Updated

2025-02-06

Healthy Volunteers

No

Interventions

PROCEDURE

Hepatic arterial infusion chemotherapy

Hepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2.

DRUG

Lenvatinib

12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day

DRUG

Tislelizumab

200mg intravenously every 3 weeks

DRUG

Toripalimab

240mg intravenously every 3 weeks

DRUG

Sintilimab

200mg intravenously every 3 weeks

DRUG

Camrelizumab

200mg intravenously every 3 weeks

Locations (1)

Chinese PLA General hospital

Beijing, Beijing Municipality, China