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

Advanced Primary Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03167775
• Other study ID #: 81YY-ZLLL-16-19
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2017
• Last updated: May 24, 2017
• Start date: November 28, 2016
• Est. completion date: November 27, 2019

Study information

• Verified date: May 2017
• Source: BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
• Contact: Shukui Qin
• Phone: 025-80864541
• Email: qinsk[@]csco.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 27, 2019
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 a-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

Related Conditions & MeSH terms

• Advanced Primary Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• Elemene Injection/Elemene Oral Emulusion

Locations

Country	Name	City	State
China	Henan Medical University Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.	Dalian Holley Kingkong Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DCR and/or 6-months survival rate	Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease/	6 months
Secondary	ORR	Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.	1year
Secondary	PFS	Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause	1 year
Secondary	OS	Overrall survival.The time of patient from randomization to death caused by any cause	3 year
Secondary	QLQ	Quality of Life Questionnaire Core 30	3 year
Secondary	the rate of incidence of adverse events	NCI CTC AE 4.03	3 year