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| ID | Type | Description | Link |
|---|---|---|---|
| Approval No. 2025-1082 | Other Identifier | Ethics Committee on Biomedical Research, West China Hospital of Sichuan University |
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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.
For patients with large right-sided HCC, resection is often precluded by insufficient future liver remnant (FLR) or high biological aggressiveness. This trial utilizes:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual-Conversion Therapy Group | Experimental | Patients receive a combination of LVD, cTACE, Tislelizumab, and Lenvatinib. • Interventions:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver Venous Deprivation (LVD) | Procedure | Simultaneous embolization of the right portal vein and right hepatic vein to induce FLR hypertrophy. |
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| 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 |
| 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 |
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingyun Xie, M.D., Ph.D. | Contact | +8618608070908 | xieqingyun@stu.scu.edu.cn | |
| Chang Liu, M.D., Ph.D. | Contact | +86-18581575861 | drliuchang@wchscu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hong Wu, M.D., Ph.D. | West China Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | 614000 | China |
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared.
Beginning 6 months and ending 36 months following article publication.
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.
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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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.
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| Conventional Transarterial Chemoembolization(C-TACE) | Procedure | Conventional TACE performed using Lipiodol and chemotherapy agents (Epirubicin/Oxaliplatin) |
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| 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) |
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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). |
| 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). |