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

Advanced Primary Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03166553
• Other study ID #: 81YY-ZLLL-16-20
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2017
• Last updated: May 23, 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 Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin in the First -line treatment of advanced primary liver cancer

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 27, 2019
• Est. primary completion date: May 28, 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 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 a-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

Related Conditions & MeSH terms

• Advanced Primary Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• Elemene

Locations

Country	Name	City	State
China	302 Military Hospital of China	Beijing	Beijing
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Jinan Military General Hospital	Jinan	Shandong
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The Affiliated Hospital of Qindao University	Qindao	Shandong
China	Shanghai Oriental Hospital	Shanghai	Shanghai
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Xiehe University of Science and Technology Affiliate Tongji Hospital	Wuhan	Hubei
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	Objective response rate and/or 1-year survival rate	Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.	1 year
Secondary	Disease control rate(DCR)	Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease.	1 year
Secondary	Progression-free survival(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	Overall survival(OS)	Overall survival.The time of patient from randomization to death caused by any cause	3 year
Secondary	Quality of Life Questionnaire (QLQ)	Quality of Life Questionnaire Core 30	3 year
Secondary	the rate of incidence of adverse events	NCI CTC AE 4.03	3 year