The Role of Low Molecular Weight Heparins (LMWH) Combined With Transarterial Chemoembolization (TACE) in Hepatocellular Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Eastern Hepatobiliary Surgery Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT00827554
First received: January 21, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

January 21, 2009
January 21, 2009
December 2008
December 2009   (final data collection date for primary outcome measure)
time-to-progression(TTP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • The overall response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • bleeding complication rate [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Progression Free Survival (PFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Role of Low Molecular Weight Heparins (LMWH) Combined With Transarterial Chemoembolization (TACE) 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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Drug: LMWH
    Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks
    Other Name: FRAXIPARINE
  • Procedure: TACE
    transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres,pharmorubicin 20mg,5-Fu 1g and Carboplatin 150mg。
  • 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
    Interventions:
    • Drug: LMWH
    • Procedure: TACE
  • Active Comparator: TACE alone
    50 HCC patients randomly assigned to receive TACE without LMWH
    Intervention: Procedure: TACE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2010
December 2009   (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.
Both
18 Years to 75 Years
No
Contact: Kan Tong, MD 86-21-81870774 kanto168.888@vip.163.com
Contact: Yang Jia-mei, MD 86-21-81870808 Yang-jia-mei@163.com
China
 
NCT00827554
EHBH-RCT-2008-011, ChiCTR-TRC-00000267
Yes
Jia-mei Yang, Department of special treatment , Eastern Hepatobiliary Surgery Hospital
Eastern Hepatobiliary Surgery Hospital
Not Provided
Study Chair: Shen Feng, MD Eastern Hepatobiliary Surgery Hospital
Eastern Hepatobiliary Surgery Hospital
January 2009

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