Back to results

The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

LMWH

TACE

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
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.
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.

Sites / Locations

Eastern Hepatobiliary Surgery Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LMWH plus TACE

TACE alone

Arm Description

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

50 HCC patients randomly assigned to receive TACE without LMWH

Outcomes

Primary Outcome Measures

time-to-progression(TTP)

Secondary Outcome Measures

The overall response rate

Overall survival (OS)

bleeding complication rate

Progression Free Survival (PFS)

Full Information

NCT ID

NCT00827554

First Posted

January 21, 2009

Last Updated

March 30, 2016

Sponsor

Eastern Hepatobiliary Surgery Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00827554

Brief Title

The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LMWH plus TACE

Arm Type

Experimental

Arm Description

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

Arm Title

TACE alone

Arm Type

Active Comparator

Arm Description

50 HCC patients randomly assigned to receive TACE without LMWH

Intervention Type

Drug

Intervention Name(s)

LMWH

Other Intervention Name(s)

fraxiparine, GlaxoSmithKline

Intervention Description

Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks

Intervention Type

Procedure

Intervention Name(s)

TACE

Other Intervention Name(s)

transarterial embolization/chemoembolization

Intervention Description

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

Primary Outcome Measure Information:

Title

time-to-progression(TTP)

Time Frame

1 year

Secondary Outcome Measure Information:

Title

The overall response rate

Time Frame

1 year

Title

Overall survival (OS)

Time Frame

1 year

Title

bleeding complication rate

Time Frame

6 weeks

Title

Progression Free Survival (PFS)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shen Feng, MD

Organizational Affiliation

Eastern Hepatobiliary Surgery Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Eastern Hepatobiliary Surgery Hospital

City

ShangHai

State/Province

Shanghai

ZIP/Postal Code

200438

Country

China

12. IPD Sharing Statement

Learn more about this trial

The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma

We'll reach out to this number within 24 hrs