A Randomized, Controlled Study to Evaluate the Efficacy and Significant of the Anti-virus Therapy for the Unresectable Hepatitis B Virus-related Primary Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- time-to-progression(TTP)
研究概览
简要总结
This study is working to research the efficacy and significant of the anti-virus therapy in the unresectable Hepatitis B virus (HBV) related primary liver cancer(PLC) so as to establish treatment standards of anti-virus therapy in PLC.
详细描述
primary liver cancer(PLC)is one of the world's most common malignancies, especially in East-Asian countries.Hepatitis B virus (HBV) infection is associated with 70-90% of PLC cases in China. PLC can develop during any stage of the natural course of chronic HBV infection and anti-virus therapy should be considered during the management of PLC. However, there is no definite guide on when or how to practice the anti-virus therapy, especially in unresectable or inoperable PLC. Because of these facts, research on the significant of the anti-virus therapy in the HBV-related PLC is urgently needed.
200 patients will be randomly assigned to anti-virus therapy group and control gruop.The time to progression(TTP) and overall survival within two years will be used to evaluate the effect of anti-virus therapy on PLC.
The aim of this study is to research the efficacy and significant of the anti-virus therapy in the unresectable HBV-related PLC so as to establish treatment standards of anti-virus therapy in PLC.
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
- •Identify patients with PLC in accordance with the clinical diagnostic criteria of PLC.Patients with PLC shall be diagnosed with or without pathology. It is not appropriate to perform liver resection operation.
- •serum positive HBsAg≥6 months.
- •Criteria of liver function: Child A or B level, serum total bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 10 times the upper limit of normal value.
- •hemoglobin≥8.5g/dl, PT-INR≤2.3 or PT>6 seconds of normal value.
- •No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
- •Patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent.
排除标准
- •Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction, which may affect the treatment of liver cancer.
- •Patients with other diseases which may affect the treatment mentioned here.
- •Patients with medical history of other malignant tumors.
- •Subjects participating in other clinical trials.
- •Women in pregnancy and breast-feeding.
研究组 & 干预措施
anti-virus therapy
100 HCC patients will be allocated to receive anti-virus therapy.
干预措施: Entecavir (Drug)
conventional therapy
100 patients will undergo conventional therapy
干预措施: conventional therapy (Drug)
结局指标
主要结局
time-to-progression(TTP)
时间窗: 1,2 and 3 years
次要结局
- Overall survival (OS)(1,2 and 3 years)
- The overall response rate(1,2 and 3 years)
研究者
ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospotal
Eastern Hepatobiliary Surgery Hospital