Trial | NCT00827554  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
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.
Study Started
Dec 31
2008
Primary Completion
Aug 31
2011
Study Completion
Oct 31
2011
Last Update
Apr 01
2016
Estimate

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 names: transarterial embolization/chemoembolization

LMWH plus TACE Experimental

50 HCC patients will be allocated to receive Nadroparin 4100 AXa iu twice daily 3 days after TACE which lasted for 6 weeks

TACE alone Active Comparator

50 HCC patients randomly assigned to receive TACE without LMWH

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.
No Results Posted