Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 主要终点
- Overall survival rate
研究概览
简要总结
HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic and extrahepatic portal branches participated in the study. Patients were randomized allocated in liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered to patients twice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18～70 years of age (Male and Female).
- •Clinical diagnosis of advanced hepatocellular carcinoma who could accept liver transplantation
- •Patients who had unresectable HCC >5 cm and no metastasis in lungs and bones were eligible to participate in this study. Tumor involvement in the intrahepatic and extrahepatic portal branches was not considered to be an exclusion criterion.
- •No prior chemotherapy, radiation therapy, targeted therapy or other kind of biological treatment within 4 weeks.
- •Provide written informed consent
排除标准
- •Metastasis in lungs and bones
- •Invasion in main vescular.
- •Contraindications of liver transplantation
- •Contraindications of operation of other organ system
- •Hypersensitivity to adenovirus, GCV or similar drugs
- •Accept clinical trials of other drugs
- •Immunological deficit
- •Active pregnancy
- •Unable or unwilling to sign informed consents
研究组 & 干预措施
LT+ADV-TK
Liver transplantation and double-dose ADV-TK/ganciclovir administration The first ADV-TK dose was administered before closing the peritoneal layer; the second ADV-TK dose was administered 2 months after LT; ganciclovir was slowly administered 36 hours after LT and twice daily for 14 days.
干预措施: ADV-TK (Drug)
LT+ADV-TK
Liver transplantation and double-dose ADV-TK/ganciclovir administration The first ADV-TK dose was administered before closing the peritoneal layer; the second ADV-TK dose was administered 2 months after LT; ganciclovir was slowly administered 36 hours after LT and twice daily for 14 days.
干预措施: LT (Procedure)
LT+ADV-TK
Liver transplantation and double-dose ADV-TK/ganciclovir administration The first ADV-TK dose was administered before closing the peritoneal layer; the second ADV-TK dose was administered 2 months after LT; ganciclovir was slowly administered 36 hours after LT and twice daily for 14 days.
干预措施: ganciclovir (Drug)
LT
Orthotopic liver transplantation
干预措施: LT (Procedure)
结局指标
主要结局
Overall survival rate
时间窗: up to 3-year
Recurrence-free survival rate
时间窗: up to 3-year
次要结局
未报告次要终点
研究者
Ding Ma
Director of the Laboratory of Tumor invasion and metastasis
Huazhong University of Science and Technology