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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Conversion-to-Surgery Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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).
干预措施: 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).
干预措施: 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).
干预措施: Tislelizumab combined with Lenvatinib (Drug)
结局指标
主要结局
Conversion-to-Surgery Rate
时间窗: 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
次要结局
- 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).)
研究者
Hong Wu
Vice President of West China Hospital, Sichuan University
West China Hospital