Clinical Trial of Elemene in Combination With Oxaliplatinin the Treatment of Advanced Primary Liver Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Advanced Primary Liver Cancer

Intervention / Treatment
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* Drug: Elemene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group treated with the Elemene Injection/Elemene Oral Emulusion in Combination with Systematic Chemotherapy including Oxaliplatin , another group treated with Systematic Chemotherapy including Oxaliplatin.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elemene +Oxaliplatin<br>the group treated with the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin | Drug: Elemene<br> <br> * Other names: Oxaliplatin;|
| No Intervention: Oxaliplatin<br>the group treated with Systematic Chemotherapy including Oxaliplatin | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate and/or 1-year survival rate | Objective response rate.The proportion of patients who had a best response rating of complete response and partial response. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate(DCR) | Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease. | 1 year | 
| Progression-free survival(PFS) | Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause | 1 year | 
| Overall survival(OS) | Overall survival.The time of patient from randomization to death caused by any cause | 3 year | 
| Quality of Life Questionnaire (QLQ) | Quality of Life Questionnaire Core 30 | 3 year | 
| the rate of incidence of adverse events | NCI CTC AE 4.03 | 3 year |