Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:11 AM
Study NCT ID:
NCT07483359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus
Sponsor:
First Hospital of China Medical University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONV3RSION
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: