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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Hospital of China Medical University

About this trial

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.

Eligibility criteria

Qualifiers

Voluntarily sign the written informed consent form.

Age 18 to 80 years (inclusive), male or female.

Histologically or cytologically confirmed Hepatocellular Carcinoma (HCC) according to the "Clinical Practice Guideline for Primary Liver Cancer (2024 Edition)," and evaluated by a Multi-Disciplinary Team (MDT) as initially unresectable.

No prior systemic anti-tumor therapy (including targeted therapy, immunotherapy, and systemic chemotherapy).

Disqualifiers

History of other active malignancies within 5 years (except for adequately treated basal cell carcinoma of the skin or papillary thyroid cancer).

Evidence of extrahepatic metastasis confirmed by chest, abdomen, and pelvis CT and/or MRI scans.

Presence of clinically significant ascites.

History of hepatic encephalopathy.

Trial design

Treatments tested in this trial

  • HAIC + Tislelizumab +lenvatinib

Treatment groups

38 Participants
are divided into 1 treatment group

Sponsors and collaborators

First Hospital of China Medical University

Lead sponsor

Liaoning Cancer Hospital & Institute

Collaborator

The Affiliated Hospital of Yanbian University

Collaborator