Clinical Trial of Elemene in Combination With Oxaliplatinin the Treatment of Advanced Primary Liver Cancer
- Registration Number
- NCT03166553
- Lead Sponsor
- BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elemene +Oxaliplatin Elemene the group treated with the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin
- Primary Outcome Measures
Name Time Method Objective response rate and/or 1-year survival rate 1 year Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.
- Secondary Outcome Measures
Name Time Method Progression-free survival(PFS) 1 year Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause
Disease control rate(DCR) 1 year Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease.
Quality of Life Questionnaire (QLQ) 3 year Quality of Life Questionnaire Core 30
Overall survival(OS) 3 year Overall survival.The time of patient from randomization to death caused by any cause
the rate of incidence of adverse events 3 year NCI CTC AE 4.03
Trial Locations
- Locations (10)
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Jinan Military General Hospital
🇨🇳Jinan, Shandong, China
Henan Medical University Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The Affiliated Hospital of Qindao University
🇨🇳Qindao, Shandong, China
302 Military Hospital of China
🇨🇳Beijing, Beijing, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Shanghai Oriental Hospital
🇨🇳Shanghai, Shanghai, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Xiehe University of Science and Technology Affiliate Tongji Hospital
🇨🇳Wuhan, Hubei, China