The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma

NCT ID: NCT00827554

Last Updated: 2016-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-10-31

Brief Summary

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.

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

LMWH

Intervention Type: DRUG

Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks

TACE

Intervention Type: PROCEDURE

transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres，pharmorubicin 20mg，5-Fu 1g and Carboplatin 150mg。

TACE alone

50 HCC patients randomly assigned to receive TACE without LMWH

Group Type: ACTIVE_COMPARATOR

LMWH

Intervention Type: DRUG

Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks

TACE

Intervention Type: PROCEDURE

transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres，pharmorubicin 20mg，5-Fu 1g and Carboplatin 150mg。

Interventions

LMWH

Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks

Intervention Type: DRUG

TACE

transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres，pharmorubicin 20mg，5-Fu 1g and Carboplatin 150mg。

Intervention Type: PROCEDURE

Other Intervention Names

fraxiparine; GlaxoSmithKline; transarterial embolization/chemoembolization

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: lead

Responsible Party

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospotal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shen Feng, MD

Role: STUDY_CHAIR

Eastern Hepatobiliary Surgery Hospital

Locations

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

EHBH-RCT-2008-011

Identifier Type: -

Identifier Source: org_study_id