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.
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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).
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.
Single group
HAIC + Tislelizumab +lenvatinib
Combination productTislelizumab: 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.
Technical Resectability Rate (TRR)
The percentage of participants whose disease converts from initially unresectable to technically resectable, as evaluated by a Blinded Independent Review Committee (IRC) based on multimodal radiological imaging. The criteria for successful conversion include the anatomical feasibility of achieving an R0 resection, the adequacy of the future liver remnant (FLR), and the successful downstaging of the Vp3 portal vein tumor thrombus (PVTT).
1-Year Overall Survival (OS) Rate
The percentage of participants who remain alive at 12 months from the date of the first dose of study treatment.
Progression-Free Survival (PFS) per RECIST v1.1
Time from the first dose of study treatment to the first documented objective disease progression, as assessed by the IRC using RECIST v1.1 criteria, or death from any cause, whichever occurs first.
Progression-Free Survival (PFS) per mRECIST
Time from the first dose of study treatment to the first documented objective disease progression, as assessed by the IRC using modified RECIST (mRECIST) criteria for hepatocellular carcinoma, or death from any cause, whichever occurs first.
Time to Progression (TTP) per RECIST v1.1
Time from the first dose of study treatment to the first documented objective disease progression, as assessed by the IRC using RECIST v1.1 criteria.
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First Hospital of China Medical University
Lead sponsor
Liaoning Cancer Hospital & Institute
Collaborator
The Affiliated Hospital of Yanbian University
Collaborator
