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Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus

NCT07483359 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-03-19

No results posted yet for this study

Summary

Patients with hepatocellular carcinoma (HCC) complicated by Vp3 portal vein tumor thrombus (PVTT) face a poor prognosis and are typically ineligible for surgical resection. This prospective study evaluates a conversion therapy regimen-utilizing a combination of FOLFOX-HAIC, Lenvatinib, and Tislelizumab-designed to induce significant regression of both the tumor burden and the PVTT. The primary objective is to determine the Technical Resectability Rate (TRR), assessing the potential for this triple-combination therapy to downstage initially unresectable disease to a state suitable for curative-intent R0 surgical resection.

Conditions

  • Hepatocellular Carcinoma (HCC)
  • Portal Vein Tumor Thrombus

Interventions

COMBINATION_PRODUCT

HAIC + Tislelizumab +lenvatinib

Tislelizumab: 200 mg administered intravenously each 21-day cycle. FOLFOX-HAIC: Administered every 21 days for up to a maximum of 6 cycles. The regimen consists of Oxaliplatin 85 mg/m², Leucovorin 400 mg/m², and 5-Fluorouracil 2500 mg/m² given as a continuous hepatic arterial infusion over 46-48 hours. Lenvatinib: Administered orally once daily on a continuous basis. Dosing is weight-adjusted: 12 mg/day for patients weighing ≥60 kg, and 8 mg/day for patients weighing \<60 kg.

Sponsors & Collaborators

  • Liaoning Cancer Hospital & Institute

    collaborator OTHER

  • The Affiliated Hospital of Yanbian University

    collaborator OTHER

  • First Hospital of China Medical University

    lead OTHER

Principal Investigators

  • Kai Li, MD, PhD · First Hospital of China Medical University

  • Haibo Shao, MD, PhD · First Hospital of China Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-06-30
Completion
2028-05-31

Countries

  • China

Study Locations

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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 NCT07483359 on ClinicalTrials.gov