- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03167775
Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer
May 24, 2017 updated by: BeiJing Yijiayi Medicine Techonoloy Co., Ltd.
Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best Supportive Treatment in the Treatment of Advanced Primary Liver Cancer
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- 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
- Name: Shukui Qin
- Phone Number: 025-80864541
- Email: qinsk@csco.org.cn
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450000
- Recruiting
- Henan Medical University Cancer Hospital
-
Contact:
- Huaimin Liu
-
-
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
Ages Eligible for Study
16 years to 73 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 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)
- 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.
Exclusion Criteria:
- 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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Elemene + the best supportive treatment
the patients will be treated with the Elemene Injection/Elemene Oral Emulusion in Combination with the best supportive treatment .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DCR and/or 6-months survival rate
Time Frame: 6 months
|
Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease/
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: 1year
|
Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.
|
1year
|
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
|
OS
Time Frame: 3 year
|
Overrall survival.The time of patient from randomization to death caused by any cause
|
3 year
|
QLQ
Time Frame: 3 year
|
Quality of Life Questionnaire Core 30
|
3 year
|
the rate of incidence of adverse events
Time Frame: 3 year
|
NCI CTC AE 4.03
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
November 28, 2016
Primary Completion (Anticipated)
May 27, 2019
Study Completion (Anticipated)
November 27, 2019
Study Registration Dates
First Submitted
May 22, 2017
First Submitted That Met QC Criteria
May 24, 2017
First Posted (Actual)
May 30, 2017
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 24, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81YY-ZLLL-16-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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