Safety and Efficacy of LVD + C-TACE + Tis/Len for Unresectable Right-Liver HCC

Official title

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.

Overview

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.

Detailed description

For patients with large right-sided HCC, resection is often precluded by insufficient future liver remnant (FLR) or high biological aggressiveness. This trial utilizes:

1. Mechanical Conversion: LVD (simultaneous portal and hepatic vein embolization) to trigger rapid FLR hypertrophy. 2. Biological Conversion: cTACE combined with systemic therapy (Tislelizumab + Lenvatinib) to control tumor growth and reduce tumor stage.

Patients will undergo "Dual-Conversion" therapy and be assessed for surgical resectability every 3-6 weeks. Success is defined as achieving R0 resection with a safe FLR-to-body weight ratio.

Interventions

• Procedure Liver Venous Deprivation (LVD)
  Simultaneous embolization of the right portal vein and right hepatic vein to induce FLR hypertrophy.
• Procedure Conventional Transarterial Chemoembolization(C-TACE)
  Conventional TACE performed using Lipiodol and chemotherapy agents (Epirubicin/Oxaliplatin)
• Drug Tislelizumab combined with Lenvatinib
  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)

Primary outcome measures

• Conversion-to-Surgery Rate [Time frame: From enrollment to the end of treatment at 12 weeks]

Secondary outcome measures (4)

• Objective Response Rate (ORR) [Time frame: Every 4-8 weeks (up to 3 years)]
• Kinetic Growth Rate (KGR) of FLR [Time frame: 3-4 weeks post-LVD.]
• Progression-Free Survival (PFS) [Time frame: Every 4-8 weeks (up to 3 years).]
• Incidence of Treatment-Related Adverse Events (TRAEs) [Time frame: From the first dose until 30 days after the last treatment (up to 2 years).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• West China Hospital, Sichuan University — Chengdu

Identifiers

NCT: NCT07480382 · iDUCONVER-001 · Approval No. 2025-1082

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗