The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma

NCT00827554 | Completed Phase 2 DMC

• 1 other identifier: EHBH-RCT-2008-011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Liver Neoplasms; Liver Diseases; Digestive System Diseases; Digestive System Neoplasms; Carcinoma, Hepatocellular; Gastrointestinal Neoplasms; Adenocarcinoma; Hepatocellular carcinoma; Neoplasms; Transarterial chemoembolization; Nadroparin; low-molecular-weight heparin; chemoembolization

Outcome Measures

Primary Outcomes (1)

• time-to-progression(TTP)

  1 year

Secondary Outcomes (4)

• The overall response rate

  1 year

• Overall survival (OS)

  1 year

• bleeding complication rate

  6 weeks

• Progression Free Survival (PFS)

  1 year

Study Arms (2)

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

Drug: LMWH; Procedure: TACE

TACE alone

ACTIVE COMPARATOR

50 HCC patients randomly assigned to receive TACE without LMWH

Drug: LMWH; Procedure: TACE

Interventions

LMWH DRUG

Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks

Also known as: fraxiparine, GlaxoSmithKline

LMWH plus TACE; TACE alone

TACE PROCEDURE

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

Also known as: transarterial embolization/chemoembolization

LMWH plus TACE; TACE alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Liver Diseases; Digestive System Diseases; Digestive System Neoplasms; Gastrointestinal Neoplasms; Adenocarcinoma; Neoplasms

Interventions

Heparin, Low-Molecular-Weight; Nadroparin; halofantrine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms by Site; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Shen Feng, MD

  Eastern Hepatobiliary Surgery Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: December 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

CN (1)