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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03166553
Recruitment Status : Unknown
Verified May 2017 by BeiJing Yijiayi Medicine Techonoloy Co., Ltd..
Recruitment status was:  Recruiting
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Sponsor:
Collaborator:
Dalian Holley Kingkong Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.

Brief 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

Condition or disease Intervention/treatment Phase
Advanced Primary Liver Cancer Drug: Elemene Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One group treated with the Elemene Injection/Elemene Oral Emulusion in Combination with Systematic Chemotherapy including Oxaliplatin , another group treated with Systematic Chemotherapy including Oxaliplatin.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 28, 2016
Estimated Primary Completion Date : May 28, 2019
Estimated Study Completion Date : November 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
Drug Information available for: Oxaliplatin

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 Name: Oxaliplatin

No Intervention: Oxaliplatin
the group treated with Systematic Chemotherapy including Oxaliplatin



Primary Outcome Measures :
  1. Objective response rate and/or 1-year survival rate [ Time Frame: 1 year ]
    Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.


Secondary Outcome Measures :
  1. Disease control rate(DCR) [ Time Frame: 1 year ]
    Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease.

  2. Progression-free survival(PFS) [ Time Frame: 1 year ]
    Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause

  3. Overall survival(OS) [ Time Frame: 3 year ]
    Overall survival.The time of patient from randomization to death caused by any cause

  4. Quality of Life Questionnaire (QLQ) [ Time Frame: 3 year ]
    Quality of Life Questionnaire Core 30

  5. the rate of incidence of adverse events [ Time Frame: 3 year ]
    NCI CTC AE 4.03



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166553


Contacts
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Contact: Shukui Qin 025-80864541 qinsk@csco.org.cn

Locations
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China, Beijing
302 Military Hospital of China Not yet recruiting
Beijing, Beijing, China, 100039
Contact: Yinying Lu         
China, Gansu
The First Hospital of Lanzhou University Not yet recruiting
Lanzhou, Gansu, China, 730000
Contact: Da Zhao         
China, Hebei
The First Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Yonghui An         
China, Heilongjiang
Harbin Medical University Cancer Hospital Not yet recruiting
Harbin, Heilongjiang, China, 150000
Contact: Yuxian Bai         
China, Henan
Henan Medical University Cancer Hospital Not yet recruiting
Zhengzhou, Henan, China, 450000
Contact: Huaimin Liu         
China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Xianglin Yuan         
Xiehe University of Science and Technology Affiliate Tongji Hospital Not yet recruiting
Wuhan, Hubei, China, 43000
Contact: Tao Zhang         
China, Shandong
Jinan Military General Hospital Not yet recruiting
Jinan, Shandong, China, 250000
Contact: Baochen Wang         
The Affiliated Hospital of Qindao University Not yet recruiting
Qindao, Shandong, China, 266000
Contact: Wensheng Qiu         
China, Shanghai
Shanghai Oriental Hospital Not yet recruiting
Shanghai, Shanghai, China, 200000
Contact: Jin Li         
Sponsors and Collaborators
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
Dalian Holley Kingkong Pharmaceutical Co., Ltd
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Responsible Party: BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
ClinicalTrials.gov Identifier: NCT03166553    
Other Study ID Numbers: 81YY-ZLLL-16-20
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Oxaliplatin
Antineoplastic Agents