Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer

BeiJing Yijiayi Medicine Techonoloy

Status

Unknown

Conditions

Advanced Primary Liver Cancer

Treatments

Drug: Elemene Injection/Elemene Oral Emulusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT03167775

81YY-ZLLL-16-19

Details and patient eligibility

About

Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer

Full 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

Enrollment

30 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 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