The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital
• Treatments: Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Nadroparin

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.