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Status unknownNCT03166553Updated May 25, 2017

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

An interventional study of Elemene in Advanced Primary Liver Cancer, sponsored by BeiJing Yijiayi Medicine Techonoloy Co., Ltd.. Status unknown at 10 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-25.

Sponsored by BeiJing Yijiayi Medicine Techonoloy Co., Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2016, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Advanced Primary Liver Cancer
03

In context

Lead sponsor

BeiJing Yijiayi Medicine Techonoloy Co., Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Elemene +Oxaliplatin

    the group treated with the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin

    Drug: Elemene

  • No intervention
    Oxaliplatin

    the group treated with Systematic Chemotherapy including Oxaliplatin

Interventions

  • Also known as: Oxaliplatin

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. 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

    Time frame: 1 year

  3. Overall survival(OS)

    Overall survival.The time of patient from randomization to death caused by any cause

    Time frame: 3 year

  4. Quality of Life Questionnaire (QLQ)

    Quality of Life Questionnaire Core 30

    Time frame: 3 year

  5. the rate of incidence of adverse events

    NCI CTC AE 4.03

    Time frame: 3 year

07

Study locations

1 of 10 sites recruiting
  • 302 Military Hospital of China
    Beijing, Beijing Municipality 100039, China
    Not yet recruiting
    • Yinying Lu · Contact
  • The First Hospital of Lanzhou University
    Lanzhou, Gansu 730000, China
    Not yet recruiting
    • Da Zhao · Contact
  • The First Hospital of Hebei Medical University
    Shijiazhuang, Hebei 050000, China
    Recruiting
    • Yonghui An · Contact
  • Harbin Medical University Cancer Hospital
    Harbin, Heilongjiang 150000, China
    Not yet recruiting
    • Yuxian Bai · Contact
  • Henan Medical University Cancer Hospital
    Zhengzhou, Henan 450000, China
    Not yet recruiting
    • Huaimin Liu · Contact
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430000, China
    Not yet recruiting
    • Xianglin Yuan · Contact
  • Xiehe University of Science and Technology Affiliate Tongji Hospital
    Wuhan, Hubei 43000, China
    Not yet recruiting
    • Tao Zhang · Contact
  • Jinan Military General Hospital
    Jinan, Shandong 250000, China
    Not yet recruiting
    • Baochen Wang · Contact
  • The Affiliated Hospital of Qindao University
    Qindao, Shandong 266000, China
    Not yet recruiting
    • Wensheng Qiu · Contact
  • Shanghai Oriental Hospital
    Shanghai, Shanghai Municipality 200000, China
    Not yet recruiting
    • Jin Li · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03166553
Lead sponsor
BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
Collaborators
Dalian Holley Kingkong Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
May 25, 2017
Start date
Nov 28, 2016
Primary completion
May 28, 2019 (estimated)
Completion
Nov 27, 2019 (estimated)
Last update
May 25, 2017

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Elemene

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