Clinical trial NCT03167775: Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer
Official title: Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Primary Liver Cancer
Lead sponsor: BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Dalian Holley Kingkong Pharmaceutical Co., Ltd
First posted: 2017-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: DCR and/or 6-months survival rate
timeFrame: 6 months
Secondary outcomes:
measure: ORR
timeFrame: 1year
measure: PFS
timeFrame: 1 year
measure: OS
timeFrame: 3 year
measure: QLQ
timeFrame: 3 year
measure: the rate of incidence of adverse events
timeFrame: 3 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Medical University Cancer Hospital
state: Henan
Study officials:
References: