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
Sponsors and collaborators
First Hospital of China Medical University
Lead sponsor
Liaoning Cancer Hospital & Institute
Collaborator
The Affiliated Hospital of Yanbian University
Collaborator