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Advanced Primary Liver CancerNCT03166553

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

A study testing Elemene in people with Advanced Primary Liver Cancer, run by BeiJing Yijiayi Medicine Techonoloy Co., Ltd. at 10 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Primary Liver Cancer
What is being tested?
Elemene
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
10 sitesChina
Study dates
28 Nov 2016to 27 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

10 sites in 1 country.

Shukui Qin contact

025-80864541

qinsk@csco.org.cn

10 sites in 1 country

China10 sites, 10 recruiting

  • 302 Military Hospital of China

    Beijing, Beijing Municipality, 100039

    Yinying Lu

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Yuxian Bai

    Not yet recruiting

  • Jinan Military General Hospital

    Jinan, Shandong, 250000

    Baochen Wang

    Not yet recruiting

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Da Zhao

    Not yet recruiting

  • The Affiliated Hospital of Qindao University

    Qindao, Shandong, 266000

    Wensheng Qiu

    Not yet recruiting

  • Shanghai Oriental Hospital

    Shanghai, Shanghai Municipality, 200000

    Jin Li

    Not yet recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Yonghui An

    Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Xianglin Yuan

    Not yet recruiting

  • Xiehe University of Science and Technology Affiliate Tongji Hospital

    Wuhan, Hubei, 43000

    Tao Zhang

    Not yet recruiting

  • Henan Medical University Cancer Hospital

    Zhengzhou, Henan, 450000

    Huaimin Liu

    Not yet recruiting

Other trials in China

About this study

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 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

Being tested
Elemene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElemeneDrug

    Also called Oxaliplatin

Study groups in NCT03166553
Study groupRoleWhat they receive
Elemene +OxaliplatinExperimentalthe group treated with the Elemene Injection/Elemene Oral Emulsion in Combination with Systematic Chemotherapy including Oxaliplatin
Receives: Drug: Elemene
OxaliplatinNo interventionthe group treated with Systematic Chemotherapy including Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (5)

  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.

    Measured: 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

    Measured: 1 year

  3. Overall survival(OS)

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

    Measured: 3 year

  4. Quality of Life Questionnaire (QLQ)

    Quality of Life Questionnaire Core 30

    Measured: 3 year

  5. the rate of incidence of adverse events

    NCI CTC AE 4.03

    Measured: 3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2017
  2. Study start28 Nov 2016
  3. Primary completion28 May 2019 (estimated)
  4. Study completion27 Nov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03166553
Sponsor's protocol ID
81YY-ZLLL-16-20
Status last verified
May 2017
First submitted
22 May 2017
Last updated
25 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Elemene in people with Advanced Primary Liver Cancer, run by BeiJing Yijiayi Medicine Techonoloy Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shukui Qin (025-80864541, qinsk@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate and/or 1-year survival rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03166553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.

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Clinical Trial NCT03166553 | AzTrials