A Prospective, Single-Center, Single-Arm Trial to Validate the Safety and Efficacy of "Dual-Conversion" Therapy With Liver Venous Deprivation (LVD), Conventional Transarterial Chemoembolization (cTACE), Tislelizumab, and Lenvatinib for Initially Unresectable Hepatocellular Carcinoma in the Right Liver.
Sponsor study identifier
Secondary identifiers
OTHER · Ethics Committee on Biomedical Research, West China Hospital of Sichuan University
interventional
30
1 country
1
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study evaluates a novel "Dual-Conversion" strategy (mechanical volume conversion via LVD plus biological conversion via cTACE, Tislelizumab, and Lenvatinib) for patients with initially unresectable right-sided hepatocellular carcinoma (HCC). The primary goal is to assess the rate of successful conversion to R0 resection and the safety profile of this multi-modal approach.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 14, 2026
Actual (reported)March 18, 2026
Actual (reported)April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Conversion-to-Surgery Rate
The proportion of patients who successfully undergo R0 resection after receiving the dual-conversion therapy
From enrollment to the end of treatment at 12 weeks
Objective Response Rate (ORR)
Every 4-8 weeks (up to 3 years)
Kinetic Growth Rate (KGR) of FLR
3-4 weeks post-LVD.
Progression-Free Survival (PFS)
Every 4-8 weeks (up to 3 years).
Incidence of Treatment-Related Adverse Events (TRAEs)
From the first dose until 30 days after the last treatment (up to 2 years).
Correlation of Potential Biomarkers with Therapeutic Outcomes (Exploratory Strategy)
Baseline, during treatment cycles, and post-surgery (up to 3 years).
Pathological Response and Tissue Biomarker Signatures
At the time of surgical resection (up to 12 months).
Patients receive a combination of LVD, cTACE, Tislelizumab, and Lenvatinib. • Interventions: * Procedure: Liver Venous Deprivation (LVD) Simultaneous embolization of the right portal vein and right hepatic vein to induce FLR hypertrophy. * Procedure: cTACE Conventional TACE performed using Lipiodol and chemotherapy agents (Epirubicin/Oxaliplatin). * Drug: Tislelizumab 200 mg administered intravenously every 3 weeks (Q3W). * Drug: Lenvatinib 8 mg (for weight \<60 kg) or 12 mg (for weight ≥60 kg) orally once daily (QD).
Simultaneous embolization of the right portal vein and right hepatic vein to induce FLR hypertrophy.
Conventional TACE performed using Lipiodol and chemotherapy agents (Epirubicin/Oxaliplatin)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Tislelizumab combined with Lenvatinib
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordWest China Hospital, Sichuan University
Chengdu, Sichuan, 614000, China
Hong Wu, M.D., Ph.D.
West China Hospital
First Submitted
March 14, 2026
First Posted
March 18, 2026
Study Start
Tislelizumab 200 mg administered intravenously every 3 weeks (Q3W) + 8 mg (for weight \<60 kg) or 12 mg (for weight ≥60 kg) orally once daily (QD)
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April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 18, 2026
Record last verified: 2026-03
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared.
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Source: ClinicalTrials.gov.
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