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Advanced Primary Liver CancerNCT03167775

Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer

A study testing Elemene Injection/Elemene Oral Emulusion in people with Advanced Primary Liver Cancer, run by BeiJing Yijiayi Medicine Techonoloy Co., Ltd. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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 Emulusion in Combination With the Best Supportive Treatment in the 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 Injection/Elemene Oral Emulusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
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 cancerin 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
  • have systematic treatment before( including systematic chemotherapy and/or molecular targeted therapy) , but the treatment was unsuccessed and the tumor progress
  • According to RECIST V1.1，1at least has one measurable lesions
  • ECOG Score ≤2
  • Patients who have primary liver cancer with Child - Pugh liver function grade rating A or better B(score<=7)
Show all 9Show fewer
  • 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>=60×10^9/L. Biochemical test：a. ALB>=29g/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 other anti-cancer treatment ， including α-IFN，Arsenious Acid Injection and other Traditional Chinese Medicine Patent Prescription for treating cancer
  • 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
  • Patients with severe acute infection and cann't be controled , Chronic suppurative infection , body temperature>=39℃ ， Pleural effusion（medium and large） combined with infection
  • 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

1 site in 1 country.

Shukui Qin contact

025-80864541

qinsk@csco.org.cn

China1 site, 1 recruiting

  • Henan Medical University Cancer Hospital

    Zhengzhou, Henan, 450000

    Huaimin Liu

    Recruiting

Other trials in China

About this study

Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer

Read the detailed description

Patients with advanced primary liver cancer will be enrolled in the trial , then the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment .The purpose of the study is to evaluate the effect and safety of the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment in the treatment of advanced primary liver cancer

Being tested
Elemene Injection/Elemene Oral Emulusion

What participants receive

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

  • Elemene Injection/Elemene Oral EmulusionDrug

Study groups in NCT03167775
Study groupRoleWhat they receive
Elemene + the best supportive treatmentExperimentalthe patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment .
Receives: Drug: Elemene Injection/Elemene Oral Emulusion

What is being measured

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

  1. DCR and/or 6-months survival rate

    Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease/

    Measured: 6 months

Secondary outcomes (5)

  1. ORR

    Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.

    Measured: 1year

  2. 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. OS

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

    Measured: 3 year

  4. 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 posted30 May 2017
  2. Study start28 Nov 2016
  3. Primary completion27 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
Not applicable
Intervention model
Single group
Model description
the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03167775
Sponsor's protocol ID
81YY-ZLLL-16-19
Status last verified
May 2017
First submitted
22 May 2017
Last updated
30 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Elemene Injection/Elemene Oral Emulusion in people with Advanced Primary Liver Cancer, run by BeiJing Yijiayi Medicine Techonoloy Co., Ltd. at 1 site 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 8 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 30 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 1 site 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?

DCR and/or 6-months survival rate (time frame: 6 months). 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 NCT03167775.

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 30 May 2017.

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