NCT03313596Unknown3 期
Multicenter Randomized Controlled Trial of Adenovirus-mediated Adjuvant Gene Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 11
- 主要终点
- Progression-free survival, PFS
研究概览
简要总结
Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 65 years of age (Male and Female).
- •Clinical diagnosis of advanced primary hepatocellular carcinoma who could accept liver transplantation.
- •Patients who had unresectable HCC with single tumor diameter > 5 cm and ≤ 10cm; or numbers of multiple tumors >3 and ≤ 5, and the total length of foci diameter ≤ 15 cm.
- •Serum AFP ≤ 10000 ng/ml before liver transplantation.
- •Child-pugh A-B.
- •No metastasis in extrahepatic main vescular and extrahepatic lymph node detected during the operation and no metastasis of other organs.
- •Provide written informed consent before screening.
排除标准
- •Metastasis in extrahepatic organs.
- •HCC with Invasion in extrahepatic main vescular and extrahepatic organs.
- •Contraindications of operation of other organ system.
- •Hypersensitivity to adenovirus, GCV or similar drugs.
- •Serious obstacle of the mechanism of coagulation, hemorrhagic tendency, and abnormal coagulation (≥50%).
- •Plan to accept clinical trials of other antitumor drugs.
- •Immunological deficit.
- •HBsAg(+) and HBcAb(+) donor.
- •Unsuitable participate assessed by investigator.
研究组 & 干预措施
LT-only
Active Comparator
patients received orthotopic LT and subsequent immunosuppression therapy
干预措施: LT (Procedure)
LT+ADV-TK
Experimental
ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy
干预措施: ADV-Tk (Drug)
LT+ADV-TK
Experimental
ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy
干预措施: LT (Procedure)
结局指标
主要结局
Progression-free survival, PFS
时间窗: 2-year
PFS was measured from the day of liver transplantation to objective recurrence (MRI or CT) or HCC-related death, whichever occurred first.
次要结局
- Overall survival, OS(2-year)
- Time of the tumor progression,TTP(2-year)
- Median overall survival time(2-year)
研究者
Ding Ma
Director
Huazhong University of Science and Technology
研究点 (11)
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