Efficacy of antiplatelet therapy in reducing risk of recurrence for patients with hepatocellular carcinoma
- Conditions
- Neoplasms
- Registration Number
- KCT0004846
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 288
1) Patients who have been diagnosed with hepatocellular carcinoma and who have undergone surgical resection or radiofrequency ablation (RFA) as initial treatment within 3 months of the visit date.
2) Patients who were confirmed as having no residual cancer on CT or MRI after surgical resection or radiofrequency ablation (RFA)
3) Patients who voluntarily consent to participate in this study, and written consent by subject or legal representative
Any of the following subjects should be excluded from this clinical trial.
1) Patients with chronic hepatitis C who have HCV RNA detected by HCV RNA PCR
2) Patients who are receiving antiviral medication for chronic hepatitis B who are not suitable for changing to tefovir tablet according to the investigator's judgment'
2-1) Decreased renal function: at least one of basal glomerular filtration rate <60 mL / min, proteinuria, albuminuria (urine albumin: creatinine> 30 mg / g) or hypophosphatemia (<2.5 mg / dL)
2-2) Bone mineral density decrease: If you have osteopenia or osteoporosis, or if you need to use steroid drugs in the long term
3) Patients who consume excessive alcohol (male, =210g / day; female, =140g / day)
4) Patients who have received antiplatelet drugs containing aspirin (including general medicine) for at least 1 month within 5 years before screening
5) Patients who need to simultaneously administer a high risk of bleeding (non-steroidal anti-inflammatory drugs or anticoagulants)
6) Patients with risk of bleeding from esophageal varices or gastric varices during screening (high risk varicose veins: F2, F3 grade or with red color sign)
7) Patients with decompensated liver cirrhosis (Child-Pugh class B or C)
8) Patients who have hypersensitivity to tefovir or other ingredients in tefovir
9) Patients with hypersensitivity to aspirin or salicylic acid
10) Genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
11) Patients with peptic ulcer, except ulcer scars
12) Aspirin asthma (induced asthma attacks by nonsteroidal anti-inflammatory drugs) or a person with a history of it
13) Hemophilia patients
14) Patients with severe renal impairment (GFR <60 mL / min / 1.73m2, estimated by the Cockcroft-Gault formula)
15) Patients with severe heart failure
16) Patients with a tendency to bleed (Platelet count <50,000 / mm3)
17) Patients co-administered at least 15 milligrams (15 mg / week) of methotrexate for 7 days
18) Women who are pregnant, lactating or planning
19) Patients in other clinical trials within 30 days prior to screening
20) Patients who have failed to complete this study or have any medical condition that may interfere with the efficacy or safety evaluation of the investigational drug.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative recurrence rate of hepatocellular carcinoma
- Secondary Outcome Measures
Name Time Method 1) Major bleeding: Major organ bleeding; intramuscular bleeding causing intracranial, intravertebral, intraocular, posterior peritoneum, intraarticular, pleural, compartment syndrome, or reduction of Hb 2g / dL or more or 2 units of red blood cell transfusion bleeding;2) Bleeding-related mortality;3) Malignant tumors other than hepatocellular carcinoma;4) End-stage kidney disease;5) Cardiovascular events