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The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 22, 2009
Last Update Posted: April 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital
January 21, 2009
January 22, 2009
April 1, 2016
December 2008
August 2011   (Final data collection date for primary outcome measure)
time-to-progression(TTP) [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00827554 on ClinicalTrials.gov Archive Site
  • The overall response rate [ Time Frame: 1 year ]
  • Overall survival (OS) [ Time Frame: 1 year ]
  • bleeding complication rate [ Time Frame: 6 weeks ]
  • Progression Free Survival (PFS) [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma
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.
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.
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Drug: LMWH
    Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks
    Other Names:
    • fraxiparine
    • GlaxoSmithKline
  • Procedure: TACE
    transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres,pharmorubicin 20mg,5-Fu 1g and Carboplatin 150mg。
    Other Name: transarterial embolization/chemoembolization
  • 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
    • Drug: LMWH
    • Procedure: TACE
  • Active Comparator: TACE alone
    50 HCC patients randomly assigned to receive TACE without LMWH
    • Drug: LMWH
    • Procedure: TACE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Adults patients with a diagnosis of HCC which is not amenable to surgical resection, liver transplantation or local ablative therapy
  2. Without metastasis out of liver
  3. Patients must have at least one tumor lesion that meets both of the following criteria:

    1. The lesion can be accurately measured in at least one dimension according to RECIST criteria
    2. The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
  4. ECOG performance status (PS) <2
  5. No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy
  6. Child-Pugh class A or B
  7. No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
  8. Ability to understand the protocol and to agree to and sign a written informed consent document -

Exclusion Criteria:

  1. HBSAg(-),AFP(-).
  2. prothrombin time prolonged more than 4s.
  3. blood platelets count less than 50000/L.
  4. Renal failure requiring dialysis.
  5. Child-Pugh class C hepatic impairment.
  6. clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  7. History of organ allograft.
  8. Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  9. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  10. Pregnant or breast-feeding patients.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
ShenFeng, Eastern Hepatobiliary Surgery Hospital
Eastern Hepatobiliary Surgery Hospital
Not Provided
Study Chair: Shen Feng, MD Eastern Hepatobiliary Surgery Hospital
Eastern Hepatobiliary Surgery Hospital
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP