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

NCT06333561 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Feng Duan, MD · Chinese PLA General Hospital

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2024-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT06333561 on ClinicalTrials.gov