Clinical trial · Interventional
Safety and Efficacy of LVD + C-TACE + Tis/Len for Unresectable Right-Liver HCC
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Initially Unresectable Hepatocellular Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Transarterial Chemoembolization(C-TACE) | Procedure | — | UNRESOLVED |
| Liver Venous Deprivation (LVD) | Procedure | — | UNRESOLVED |
| Tislelizumab combined with Lenvatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dual-Conversion Therapy Group
- description
- 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).
- interventionNames
- Procedure: Liver Venous Deprivation (LVD)
- Procedure: Conventional Transarterial Chemoembolization(C-TACE)
- Drug: Tislelizumab combined with Lenvatinib
Primary outcomes (1)
- measure
- Conversion-to-Surgery Rate
- timeFrame
- From enrollment to the end of treatment at 12 weeks
- description
- The proportion of patients who successfully undergo R0 resection after receiving the dual-conversion therapy
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-75 years. * Confirmed HCC (histologically or by AASLD clinical criteria). * Initially unresectable HCC limited to the right liver (due to insufficient FLR or tumor characteristics). * Child-Pugh score ≤ 7 (Class A or early B). * ECOG Performance Status of 0 or 1. * Adequate organ function (marrow, hepatic, and renal). Exclusion Criteria: * Extrahepatic metastasis. * Portal vein tumor thrombus involving the main trunk (Vp4). * Previous systemic therapy for HCC. * Active autoimmune disease or history of organ transplantation. * Contraindications to LVD, TACE, or the study drugs
References
Publications (0)
Data not yet available