Initially Unresectable Hepatocellular Carcinoma
Conditions
Keywords
Liver Venous Deprivation, Dual-Conversion, Tislelizumab, Lenvatinib, Transarterial Chemoembolization, Liver Resection
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: 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
PROCEDURELiver Venous Deprivation (LVD)
Simultaneous embolization of the right portal vein and right hepatic vein to induce FLR hypertrophy.
PROCEDUREConventional Transarterial Chemoembolization(C-TACE)
Conventional TACE performed using Lipiodol and chemotherapy agents (Epirubicin/Oxaliplatin)
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)
Sponsors
Hong Wu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, single-center, single-arm trial designed to evaluate a "dual-conversion" strategy. All enrolled participants will receive a standardized multimodal intervention consisting of mechanical volume conversion (Liver Venous Deprivation, LVD) and biological conversion (Conventional Transarterial Chemoembolization \[cTACE\] combined with Tislelizumab and Lenvatinib). The study employs a single-group model to assess the safety and the rate of conversion to successful surgical resection in patients with initially unresectable right-sided hepatocellular carcinoma.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion-to-Surgery Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 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. |
| Kinetic Growth Rate (KGR) of FLR | 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. |
| Progression-Free Survival (PFS) | Every 4-8 weeks (up to 3 years). | Time from enrollment to disease progression or death from any cause. |
| Incidence of Treatment-Related Adverse Events (TRAEs) | 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. |
Countries
China
Contacts
CONTACTQingyun Xie, M.D., Ph.D.
CONTACTChang Liu, M.D., Ph.D.
STUDY_CHAIRHong Wu, M.D., Ph.D.
West China Hospital
Outcome results
None listed