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

• Status: Unknown status
• Trial end date: 2019-11-27
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
• Collaborator: Dalian Holley Kingkong Pharmaceutical Co., Ltd
• Treatments: Oxaliplatin

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