Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- DCR and/or 6-months survival rate
研究概览
简要总结
Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer
详细描述
Patients with advanced primary liver cancer will be enrolled in the trial , then the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment .The purpose of the study is to evaluate the effect and safety of the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment in the treatment of advanced primary liver cancer
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old，No limit on gender
- •Patients who are confirmed Locally advanced or metastatic primary liver cancerin accordance with the clinical diagnostic criteria , or by pathological histology or cytology examination, Patients who are unable to accept surgery,radiofrequency ablation、TACE and local therapy ，orLocal treatment progress failed
- •have systematic treatment before( including systematic chemotherapy and/or molecular targeted therapy) , but the treatment was unsuccessed and the tumor progress
- •According to RECIST V1.1，1at least has one measurable lesions
- •ECOG Score ≤2
- •Patients who have primary liver cancer with Child - Pugh liver function grade rating A or better B(score<=7)
- •Laboratory inspection basically meets the following requirements： Blood test：a. Hb>=90g/L(without blood transfusion within 14 days), b. ANC>=1.5×10^9/L, c. PLT>=60×10^9/L. Biochemical test：a. ALB>=29g/L(without blood transfusion within 14 days), b. ALT and AST <=5ULN, c. TBIL<=2ULN, d. Cr<=1.5ULN. Blood Coagulation function:PT<=ULN+6seconds.
- •Life expectancy of at least 3 months
- •Subjects join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
排除标准
- •Patients have other anti-cancer treatment ， including α-IFN，Arsenious Acid Injection and other Traditional Chinese Medicine Patent Prescription for treating cancer
- •In the past or at the same time,patients were diagnosed with other malignant tumor which have not been cured. As for skin basal cell carcinoma and cervical carcinoma in situ,they can be excepted
- •Patients with severe acute infection and cann't be controled , Chronic suppurative infection , body temperature>=39℃ ， Pleural effusion（medium and large） combined with infection
- •Women who is pregnant or during breast feeding and not willing to contraception during the test
- •Coagulation dysfunction(PT>16 seconds ， APTT>43 seconds , TT>21 seconds , Fib<2g/L) , With bleeding tendency or the presence of vital organ thrombosis (lung, brain) is receiving thrombolytic or anticoagulant therapy
- •With a mental illness, or has a history of drugs abuse
- •Patients accepted any experimental drugs in the past 4 weeks
- •Other reasons the researchers think not suitable
研究组 & 干预措施
Elemene + the best supportive treatment
the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment .
干预措施: Elemene Injection/Elemene Oral Emulusion (Drug)
结局指标
主要结局
DCR and/or 6-months survival rate
时间窗: 6 months
Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease/
次要结局
- ORR(1year)
- PFS(1 year)
- OS(3 year)
- the rate of incidence of adverse events(3 year)
- QLQ(3 year)