The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Clinical Randomized Control Trial of Combination TACE With and Without Low-molecular-weight Heparin in Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827554
• Other study ID #: EHBH-RCT-2008-011
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 21, 2009
• Last updated: March 30, 2016
• Start date: December 2008
• Est. completion date: October 2011

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• LMWH
Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks

Procedure:
• TACE
transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres,pharmorubicin 20mg,5-Fu 1g and Carboplatin 150mg?

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	ShangHai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time-to-progression(TTP)		1 year	No
Secondary	The overall response rate		1 year	No
Secondary	Overall survival (OS)		1 year	No
Secondary	bleeding complication rate		6 weeks	Yes
Secondary	Progression Free Survival (PFS)		1 year	No