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
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: LMWH
Procedure: TACE
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Randomized Control Trial of Combination TACE With and Without Low-Molecular-Weight Heparin in Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • time-to-progression(TTP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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。
Active Comparator: TACE alone
50 HCC patients randomly assigned to receive TACE without LMWH
Procedure: TACE
transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres,pharmorubicin 20mg,5-Fu 1g and Carboplatin 150mg。

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827554

Contacts
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

Locations
China, Shanghai
Eastern Hepatobiliary Surgery Hospital Recruiting
ShangHai, Shanghai, China, 200438
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   
Principal Investigator: Kan Tong, MD         
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Shen Feng, MD Eastern Hepatobiliary Surgery Hospital
  More Information

No publications provided

Responsible Party: Jia-mei Yang, Department of special treatment , Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00827554     History of Changes
Other Study ID Numbers: EHBH-RCT-2008-011, ChiCTR-TRC-00000267
Study First Received: January 21, 2009
Last Updated: January 21, 2009
Health Authority: China: Ministry of Health

Keywords provided by Eastern Hepatobiliary Surgery Hospital:
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular carcinoma
Neoplasms
Transarterial chemoembolization
Nadroparin
low-molecular-weight heparin
chemoembolization

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Nadroparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 27, 2014