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

BeiJing Yijiayi Medicine Techonoloy

Status

Unknown

Conditions

Advanced Primary Liver Cancer

Treatments

Drug: Elemene

Study type

Interventional

Funder types

Industry

Identifiers

NCT03166553

81YY-ZLLL-16-20

Details and patient eligibility

About

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

Full 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

Enrollment

150 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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