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

May 23, 2017 updated by: BeiJing Yijiayi Medicine Techonoloy Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the rate of incidence of adverse events
Time Frame: 3 year
NCI CTC AE 4.03
3 year
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.
1 year
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
1 year
Overall survival(OS)
Time Frame: 3 year
Overall survival.The time of patient from randomization to death caused by any cause
3 year
Quality of Life Questionnaire (QLQ)
Time Frame: 3 year
Quality of Life Questionnaire Core 30
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dalian Holley Kingkong Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 81YY-ZLLL-16-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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