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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Initially Unresectable Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: Liver Venous Deprivation (LVD); Procedure: Conventional Transarterial Chemoembolization(C-TACE); Drug: Tislelizumab combined with Lenvatinib

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qingyun Xie, M.D., Ph.D.; Phone Number: +8618608070908; Email: xieqingyun@stu.scu.edu.cn
• Study Contact Backup: Name: Chang Liu, M.D., Ph.D.; Phone Number: +86-18581575861; Email: drliuchang@wchscu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 614000
      • West China Hospital, Sichuan University
      • Contact: Chang Liu, M.D., Ph.D.; Phone Number: +86-18581575861; Email: drliuchang@wchscu.cn
      • Contact: Qingyun Xie, M.D., Ph.D.; Phone Number: 18608070908; Email: xieqingyun@stu.scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dual-Conversion Therapy Group; 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).

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Proportion of patients achieving Complete Response (CR) or Partial Response (PR) based on mRECIST and RECIST 1.1 criteria.	Every 4-8 weeks (up to 3 years)
Kinetic Growth Rate (KGR) of FLR	Volume increase of the Future Liver Remnant (FLR) per week (mL/week) measured by CT-based 3D reconstruction post-LVD.	3-4 weeks post-LVD.
Progression-Free Survival (PFS)	Time from enrollment to disease progression or death from any cause.	Every 4-8 weeks (up to 3 years).
Incidence of Treatment-Related Adverse Events (TRAEs)	Frequency and severity of adverse events graded by CTCAE v5.0, including TACE/LVD-related complications and immune/target-related toxicities.	From the first dose until 30 days after the last treatment (up to 2 years).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Potential Biomarkers with Therapeutic Outcomes (Exploratory Strategy)	Analysis of the correlation between potential biomarkers (including circulating tumor DNA [ctDNA], immune cell subsets, cytokines in peripheral blood, and radiomics features) and objective response (ORR), conversion success, and survival outcomes.	Baseline, during treatment cycles, and post-surgery (up to 3 years).
Pathological Response and Tissue Biomarker Signatures	Evaluation of pathological tumor changes (e.g., Ki-67, CD34) and exploratory single-cell sequencing in resected tumor and paratumoral tissues to identify biological signatures associated with "Dual-Conversion" efficacy.	At the time of surgical resection (up to 12 months).

Collaborators and Investigators

• Sponsor: Hong Wu
• Investigators: Study Chair: Hong Wu, M.D., Ph.D., West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 14, 2026
• First Submitted That Met QC Criteria: March 14, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Lenvatinib; Tislelizumab; Transarterial Chemoembolization; Liver Resection; Liver Venous Deprivation; Dual-Conversion
• Additional Relevant MeSH Terms: lenvatinib
• Other Study ID Numbers: iDUCONVER-001; Approval No. 2025-1082 (Other Identifier: Ethics Committee on Biomedical Research, West China Hospital of Sichuan University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared.
• IPD Sharing Time Frame: Beginning 6 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author [xieqingyun@stu.scu.edu.cn]. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No