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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMWH | Drug | Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| time-to-progression(TTP) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The overall response rate | 1 year | |
| Overall survival (OS) | 1 year | |
| bleeding complication rate |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Shen Feng, MD | Eastern Hepatobiliary Surgery Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Hepatobiliary Surgery Hospital | Shanghai | Shanghai Municipality | 200438 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D004067 | Digestive System Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D000230 | Adenocarcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D017762 | Nadroparin |
| C023768 | halofantrine |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| TACE | Procedure | transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres,pharmorubicin 20mg,5-Fu 1g and Carboplatin 150mg。 |
|
|
| 6 weeks |
| Progression Free Survival (PFS) | 1 year |
| D005767 | Gastrointestinal Diseases |