Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in 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 Emulusion in Combination With the Best Supportive Treatment in the 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 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

Official Title
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Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer

Conditions
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Advanced Primary Liver Cancer

Intervention / Treatment
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* Drug: Elemene Injection/Elemene Oral Emulusion


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 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. Exclusion Criteria: 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

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
Intervention Model: Single Group Assignment
Interventional Model Description: the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elemene + the best supportive treatment<br>the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment . | Drug: Elemene Injection/Elemene Oral Emulusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DCR and/or 6-months survival rate | Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease/ | 6 months | 

Secondary Outcome Measures

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