Clinical trial NCT03166553: Clinical Trial of Elemene in Combination With Oxaliplatinin the Treatment of Advanced Primary Liver Cancer
Official title: 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
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: 2017-05-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate and/or 1-year survival rate
timeFrame: 1 year
Secondary outcomes:
measure: Disease control rate(DCR)
timeFrame: 1 year
measure: Progression-free survival(PFS)
timeFrame: 1 year
measure: Overall survival(OS)
timeFrame: 3 year
measure: Quality of Life Questionnaire (QLQ)
timeFrame: 3 year
measure: the rate of incidence of adverse events
timeFrame: 3 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Military Hospital of China
state: Beijing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Medical University Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Xiehe University of Science and Technology Affiliate Tongji Hospital
state: Hubei
city: Jinan
country: China
facility: Jinan Military General Hospital
state: Shandong
city: Qindao
country: China
facility: The Affiliated Hospital of Qindao University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Oriental Hospital
state: Shanghai
Study officials:
References: