Status:
COMPLETED
The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma
Lead Sponsor:
Eastern Hepatobiliary Surgery Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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...
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 use...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00827554
Start Date
December 1 2008
End Date
October 1 2011
Last Update
April 1 2016
Active Locations (1)
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1
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China, 200438