Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07480382

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Initially Unresectable Hepatocellular Carcinoma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

  • Mechanical Conversion: LVD (simultaneous portal and hepatic vein embolization) to trigger rapid FLR hypertrophy.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liver Venous Deprivation (LVD)

Procedure

Simultaneous embolization of the right portal vein and right hepatic vein to induce FLR hypertrophy.

Conventional Transarterial Chemoembolization(C-TACE)

Procedure

Conventional TACE performed using Lipiodol and chemotherapy agents (Epirubicin/Oxaliplatin)

Tislelizumab combined with Lenvatinib

Drug

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 outcomes

  1. Conversion-to-Surgery Rate

    Time frame: From enrollment to the end of treatment at 12 weeks

    The proportion of patients who successfully undergo R0 resection after receiving the dual-conversion therapy

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Every 4-8 weeks (up to 3 years)

    Proportion of patients achieving Complete Response (CR) or Partial Response (PR) based on mRECIST and RECIST 1.1 criteria.

  2. Kinetic Growth Rate (KGR) of FLR

    Time frame: 3-4 weeks post-LVD.

    Volume increase of the Future Liver Remnant (FLR) per week (mL/week) measured by CT-based 3D reconstruction post-LVD.

  3. Progression-Free Survival (PFS)

    Time frame: Every 4-8 weeks (up to 3 years).

    Time from enrollment to disease progression or death from any cause.

  4. Incidence of Treatment-Related Adverse Events (TRAEs)

    Time frame: From the first dose until 30 days after the last treatment (up to 2 years).

    Frequency and severity of adverse events graded by CTCAE v5.0, including TACE/LVD-related complications and immune/target-related toxicities.

Other outcomes

  1. Correlation of Potential Biomarkers with Therapeutic Outcomes (Exploratory Strategy)

    Time frame: Baseline, during treatment cycles, and post-surgery (up to 3 years).

    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.

  2. Pathological Response and Tissue Biomarker Signatures

    Time frame: At the time of surgical resection (up to 12 months).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chang Liu, M.D., Ph.D.

CONTACT

[email protected]

+86-18581575861

Qingyun Xie, M.D., Ph.D.

CONTACT

[email protected]

+8618608070908

Sponsors and collaborators

Lead sponsor

Hong Wu

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.