HCV-related hepatocellular carcinoma
Conditions
Interventions
Treatment Group :Anti-viral treatment Group
Control Group :Non antiviral drug treatment
Sponsors
Beijing 302 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Patients between 18 to 70 years old; (2) Patients are diagnosed with HCV-related hepatocelluar carcinoma (HCC) and not previously treated with anti-tumoral agents. HCC was diagnosed on the basis of ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) characteristics and biochemistry (alpha-fetoprotein [AFP] serology and liver function enzymes), and was confirmed by histopathology, according to the American Association for the Study of Liver Diseases guidelines; (3) HCV diagnosis basis: Level of HCV antibody in serum is positive, HCV infection is more than six months, or the date of onset is unknown, no history of hepatitis, but the liver histopathology consistent with chronic hepatitis change or based on symptoms, signs, laboratory and radiological findings comprehensive analysis to make a diagnosis,and Child-Pugh of grade A or B; (4) They received radical hepatectomy for the initial treatment of HCC. The radical hepatectomy criterions are as following: Surgery was performed through a right subcostal incision. The abdominal cavity was carefully examined for extent of local disease and extrahepatic metastases. After mobilization of the liver, intraoperative ultrasound was performed to assess the number and the size of the lesions, and to assess the relationship of the tumor to vascular structures. Pringle maneuver was applied to occlude the blood inflow of the liver. Liver parenchymal transection was carried out by a clamp-crushing method. Resected tumors were subjected to pathological examination for tumor-free resection margin more than 1 cm without evidence of cancer metastasis; (5) They have no intrahepatic metastasis and extrahepatic metastasis such as abdominal metastasis, and lung metastasis as preoperatively diagnosed using CT, MRI or chest radiography, and also examined using ultrasonography (intraoperative ultrasound) during surgery; (6) They have no apparent abnormality of the heart, lung, and kidney; (7) They have given a written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients have received antitumoral treatments or antiviral treatments within 1 year before surgery; (2) Patients with other life-threatening diseases; (3) Patients unwilling to give informed consent; (4) Patients who are not expected to complete the study for other reasons; (5) Patients who are participating in other trials; (6) Pregnant or breast-feeding women or possible to conceive again; (7) Patients with psychological disorders, cardiac dysfunction, uncontrolled infection, uncontrolled peptic ulcer, metabolic disturbance, diabetes, cancers of other histotypes, distant metastasis of HCC, and renal dysfunction (serum creatinine more than 2.5 upper limit of normal); (8) History of malignant or metastatic tumor in other sites in last 5 years; (9) Co-infected with hepatitis B virus (HBV), human immunodeficient virus (HIV), or syphilis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival; | — |
Countries
China
Contacts
Public ContactShaogeng Zhang, Guangwen Cao
Outcome results
None listed