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
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Hong Wu
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Conversion-to-Surgery Rate
Overview
Brief Summary
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
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).
Intervention: Liver Venous Deprivation (LVD) (Procedure)
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).
Intervention: Conventional Transarterial Chemoembolization(C-TACE) (Procedure)
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).
Intervention: Tislelizumab combined with Lenvatinib (Drug)
Outcomes
Primary Outcomes
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
- 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).)
Investigators
Hong Wu
Vice President of West China Hospital, Sichuan University
West China Hospital