Clinical Trial of Elemene Injection/Elemene Oral Emulsion in Combination With Systematic Chemotherapy Including Oxaliplatin in the First -Line Treatment of Advanced Primary Liver Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 10
- 主要终点
- Objective response rate and/or 1-year survival rate
研究概览
简要总结
Clinical Trial of Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin in the First -line treatment of advanced primary liver cancer
详细描述
Patients with advanced primary liver cancer will be enrolled in the trial , then separated randomly into two group. One group treated with the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin , another group treated with Systematic Chemotherapy including Oxaliplatin. The purpose of the study is to evaluate the effect and safety of the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin in the First -line treatment of advanced primary liver cancer
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 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 cancer in 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
- •didn't have any systematic treatment including systematic chemotherapy and molecular targeted therapy
- •According to RECIST V1.1，1at least has one measurable lesions
- •ECOG Score ≤1
- •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>=80×10^9/L. Biochemical test：a. ALB>=28g/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 a adjuvant therapy using Oxaliplatin within 6 months
- •Patients have other anti-cancer treatment ， including α-IFN，Arsenious Acid Injection and other Traditional Chinese Medicine Patent Prescription for treating cancer
- •Patients blood pressure need to be controled(Systolic blood pressure>150mmHg , Diastolic blood pressure>90mmHg), Congestive heart failure , Unstable angina pectoris , New angina pectoris , and have no Myocardial infarction within 6months
- •Patients with severe acute infection and cann't be controled , Chronic suppurative infection , body temperature>=39℃ ， Pleural effusion（medium and large） combined with infection
- •Patients with central nervous system metastasis and has symptoms
- •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
- •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 +Oxaliplatin
the group treated with the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin
干预措施: Elemene (Drug)
结局指标
主要结局
Objective response rate and/or 1-year survival rate
时间窗: 1 year
Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.
次要结局
- Progression-free survival(PFS)(1 year)
- Disease control rate(DCR)(1 year)
- Quality of Life Questionnaire (QLQ)(3 year)
- Overall survival(OS)(3 year)
- the rate of incidence of adverse events(3 year)