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
Recruitment status was Recruiting
Sponsor:
Eastern Hepatobiliary Surgery Hospital
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
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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:
- 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.
Contacts and Locations
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 May 16, 2013