NCT07483359

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

Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib and Tislelizumab for Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus: A Prospective, Multicenter, Single-arm Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: First Hospital of China Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective, multicenter, single-arm clinical trial evaluates the efficacy and safety of a triple-combination conversion therapy for patients with initially unresectable hepatocellular carcinoma (HCC) complicated by Vp3 portal vein tumor thrombus (PVTT). The study aims to enroll 38 participants to assess the technical resectability rate (TRR) as the primary endpoint. Participants undergo a 21-day treatment cycle consisting regimens of intravenous Tislelizumab, FOLFOX-based hepatic arterial infusion chemotherapy (HAIC), while receiving daily oral Lenvatinib. This combination is designed to leverage the synergistic effects of high-concentration local chemotherapy and systemic targeted-immunotherapy to induce significant regression of both the tumor burden and the PVTT. The clinical pathway centers on regular response evaluations conducted every two cycles using multimodal radiological imaging. During these intervals, a dual-evaluation mechanism is employed: a Multi-Disciplinary Team (MDT) reviews the clinical and radiological data to guide real-time surgical decision-making, while a Blinded Independent Review Committee (IRC) independently evaluates the scans to formally determine the primary endpoint of technical resectability. This assessment focuses on anatomical feasibility for R0 resection, the adequacy of the future liver remnant, and the successful downstaging of the PVTT. Patients meeting the clinical conversion criteria proceed to curative-intent surgical intervention, followed by a pathological complete response (pCR) assessment. For participants who remain technically unresectable but continue to demonstrate clinical benefit, the HAIC intervention is limited to a maximum of six cycles. In these cases, systemic targeted and immunotherapy are maintained until disease progression, intolerable toxicity, or a maximum treatment duration of 24 months. The study officially concludes upon the earliest occurrence of either: the completion of the protocol-defined one-year overall survival follow-up for the final enrolled participant (including the achievement of the pre-specified data cutoff), or the point at which all surviving participants have experienced definitive disease progression or death and further data collection is no longer required.

Conditions

• Hepatocellular Carcinoma (HCC)
• Portal Vein Tumor Thrombus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-06-01
• Completion: 2028-05-01
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: China