- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00827554
The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma
March 30, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital
A Clinical Randomized Control Trial of Combination TACE With and Without Low-molecular-weight Heparin in Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is a major tumor type worldwide, especially in China as the sequence of hepatitis B and liver cirrhosis.
Activation of the coagulation system occurs commonly in patients with malignancy.
Several studies have suggested that anticoagulant therapy may improve survival in patients with malignancy.
The low molecular weight heparins (LMWHs) lend themselves to such studies because of their effects in experimental models of malignancy and the relative ease of administration compared with unfractionated heparin.
The purpose of the present RCT was to determine whether addition of LMWH to transarterial chemoembolization (TACE) would improve HCC patient outcome compared with TACE alone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
100 patients will be randomly assigned to receive either TACE alone or TACE plus LMWH.
A block of every 4 participants and a stratified randomization according to portal vein cancer emboli will be used to restrict randomization.
LMWH consisted of nadroparin Ca will be given at a dose of 4100 U twice daily during 6 weeks after TACE.
The time to progression(TTP) and overall survival within two years will be used to evaluate the effect of LMWH on HCC.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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ShangHai, Shanghai, China, 200438
- Eastern Hepatobiliary Surgery Hospital
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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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults patients with a diagnosis of HCC which is not amenable to surgical resection, liver transplantation or local ablative therapy
- Without metastasis out of liver
Patients must have at least one tumor lesion that meets both of the following criteria:
- The lesion can be accurately measured in at least one dimension according to RECIST criteria
- The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
- ECOG performance status (PS) <2
- No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy
- Child-Pugh class A or B
- No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
- Ability to understand the protocol and to agree to and sign a written informed consent document -
Exclusion Criteria:
- HBSAg(-),AFP(-).
- prothrombin time prolonged more than 4s.
- blood platelets count less than 50000/L.
- Renal failure requiring dialysis.
- Child-Pugh class C hepatic impairment.
- clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- History of organ allograft.
- Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Pregnant or breast-feeding patients.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LMWH plus TACE
50 HCC patients will be allocated to receive Nadroparin 4100 AXa iu twice daily 3 days after TACE which lasted for 6 weeks
|
Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks
Other Names:
transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres,pharmorubicin 20mg,5-Fu 1g and Carboplatin 150mg。
Other Names:
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Active Comparator: TACE alone
50 HCC patients randomly assigned to receive TACE without LMWH
|
Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks
Other Names:
transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres,pharmorubicin 20mg,5-Fu 1g and Carboplatin 150mg。
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time-to-progression(TTP)
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS)
Time Frame: 1 year
|
1 year
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Progression Free Survival (PFS)
Time Frame: 1 year
|
1 year
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The overall response rate
Time Frame: 1 year
|
1 year
|
bleeding complication rate
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: shen feng, MD, Eastern Hepatobiliary Surgery Hospital
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
December 1, 2008
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
January 21, 2009
First Submitted That Met QC Criteria
January 21, 2009
First Posted (Estimate)
January 22, 2009
Study Record Updates
Last Update Posted (Estimate)
April 1, 2016
Last Update Submitted That Met QC Criteria
March 30, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Nadroparin
Other Study ID Numbers
- EHBH-RCT-2008-011
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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