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

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 of Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin in the First -line treatment of advanced primary liver cancer

Study Overview

• Status: Unknown
• Conditions: Advanced Primary Liver Cancer
• Intervention / Treatment: Drug: Elemene

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shukui Qin; Phone Number: 025-80864541; Email: qinsk@csco.org.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Not yet recruiting
      • 302 Military Hospital of China
      • Contact: Yinying Lu
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Not yet recruiting
      • The First Hospital of Lanzhou University
      • Contact: Da Zhao
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The First Hospital Of Hebei Medical University
      • Contact: Yonghui An
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Not yet recruiting
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Not yet recruiting
      • Henan Medical University Cancer Hospital
      • Contact: Huaimin Liu
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Not yet recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 43000
      • Not yet recruiting
      • Xiehe University of Science and Technology Affiliate Tongji Hospital
  • Shandong
    • Jinan, Shandong, China, 250000
      • Not yet recruiting
      • Jinan Military General Hospital
      • Contact: Baochen Wang
    • Qindao, Shandong, China, 266000
      • Not yet recruiting
      • The Affiliated Hospital of Qindao University
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Not yet recruiting
      • Shanghai Oriental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elemene +Oxaliplatin; the group treated with the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin	Drug: Elemene; Other Names: Oxaliplatin
No Intervention: Oxaliplatin; the group treated with Systematic Chemotherapy including Oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of incidence of adverse events	NCI CTC AE 4.03	3 year
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
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
Overall survival(OS)	Overall survival.The time of patient from randomization to death caused by any cause	3 year
Quality of Life Questionnaire (QLQ)	Quality of Life Questionnaire Core 30	3 year

Collaborators and Investigators

• Sponsor: BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
• Collaborators: Dalian Holley Kingkong Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2016
• Primary Completion (Anticipated): May 28, 2019
• Study Completion (Anticipated): November 27, 2019

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 25, 2017

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: 81YY-ZLLL-16-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO