Patients after curative resection of hepatocellular carcinoma
Conditions
Interventions
Group A: No additional treatment after curative resection
Group B: Intra-arterial infusion of CDDP after curative resection An amount of 65mg/square meter of body surface of CDDP dissolved in s
Sponsors
Niigata Hepatocellular Carcinoma Therapy Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Performance status is less than 2. 2. Child-Pugh classification is A or B. 3. The following criteria are satisfied. a. WBC is more than 3,000/microliter. b. Plt is more than 50,000/microliter. c. Hb is more than 8.0 g/dl. d. Total bilirubin is 3.0 g/dl or less. e. Creatinine clearance adjusted by a body square meter of 1.73 is more than 50 ml/min. 4. There are no other active malignant diseases. 5. No additional anti-cancer treatments have been executed for the last three months, which affect on over the liver. 6. A patient can give informed consent by himself/herself.
Exclusion criteria
Exclusion criteria: 1. The history of severe allergic reaction against iodinated contrast medium and/or platinum-containing drugs. 2. A woman who is pregnant, lactating, or may become pregnant. 3. Hepatocellular carcinoma extended to the first branch of the portal vein or further. 4. Hepatocellular carcinoma extended to the inferior vena cava or further. 5. Dynamic CT or dynamic MRI revealed that hepatocellular carcinoma is solitary and 2 cm or less without vascular invasion. 6. Under interferon therapy. 7. A doctor responsible for the study judged to be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Survival 2. Recurrence-free survival based on the evaluation using computed tomography, magnetic resonance imaging or ultrasound. The evaluation should be conducted every three months and has to be performed with computed tomography or magnetic resonance imaging at least once a 6-months. 3. A way of recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. RBC, WBC including differential count, Plt, PT-INR , Bleeding time 2. TP, Alb, AST, ALT, ALP, LDH, gamma-GTP, TBil, BUN, Crt, Na, K, Cl, ChE, T Chol, HbA1c 3. Alpha-fetoprotein, Fucosylated fraction of alpha-fetoprotein, Des-gamma-carboxy prothrombin 4. Urinalysis, Creatinine clearance 5. Background a. Age, Gender, Performance status, Chest X-ray, ECG b. HBsAg, anti-HCV, Child-Pugh classification, Indocyanine green retention rate R15 and clearance rate c. Characteristics of hepatocellular carcinoma: diagnostic modality, size, number, location, extension to hepatic and/or portal vein d. Alcoholic consumption, Blood transfusion, History of treatment for hepatocellular carcinoma and/or other diseases, History of allergy Items from #1 to #3 and #4 are evaluated once a month and just before each infusion of CDDP, respectively, while those in #5 are evaluated only at the enrolment. | — |
Countries
Japan
Contacts
Public ContactTomoyuki Kubota
Niigata Hepatocellular Carcinoma Therapy Study Group Executive Office
Outcome results
None listed