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

NCT ID: NCT03167775

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-28
• Study Completion Date: 2019-11-27

Brief Summary

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

Detailed 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

Conditions

Advanced Primary Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Elemene + the best supportive treatment

the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment .

Group Type: EXPERIMENTAL

Elemene Injection/Elemene Oral Emulusion

Intervention Type: DRUG

Interventions

Elemene Injection/Elemene Oral Emulusion

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dalian Holley Kingkong Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: collaborator

BeiJing Yijiayi Medicine Techonoloy Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan Medical University Cancer Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shukui Qin

Role: CONTACT

qinsk@csco.org.cn

025-80864541

Facility Contacts

Huaimin Liu

Role: primary

Other Identifiers

81YY-ZLLL-16-19

Identifier Type: -

Identifier Source: org_study_id