Hepatocellular carcinoma
Conditions
Interventions
experimental group:Tegafur, Gimeracil and Oteracil Potassium Capsules (S1)
Sponsors
The Afiliated Tumor Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Prior informed consent2.Confirmed Diagnosis of HCC; 2. Cirrhotic subjects: Clinical diagnosis by AASLD criteriaHCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter. Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria; 3. Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory. Documentation of original biopsy for diagnosis is acceptable; 4. Advanced stage HCC/ BCLC B stage; 5. Child Pugh class A/B (=5cm; 6.2 2-3 lesions, at least one lesion>3cm; 6.3 no max limit of tumor size if more than 4 tumor lesions; 7. Male or female subjects >= 18 years of age; 8. Ability to swallow oral medications; 9. Life expectancy of at least 12 weeks; 10. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial; 11. Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:Hemoglobin > 9.0 g/dl; Absolute neutrophil count (ANC) >1,500/mm3; Platelet count 50x10^9/L; ALB>=28g/L; Total bilirubin < 2 mg/dL; ALT and AST < 5 x upper limit of normal; BUN and creatinine < 1.5 x upper limit of normal;INR < 1.7, or PT < 4 seconds above control.
Exclusion criteria
Exclusion criteria: 1. Vascular invasion in main portal vein, hepatic vein or inferior vena cava; 2. Biliary tract obstruction; 3. Presence of metastasis in biliary tract, brain or bone; 4. Any contraindications for hepatic embolization procedures(known hepatofugal blood flow,known portal-systemic shunt, renal failure/insufficiency requiring hemo-or peritoneal dialysis); 5. Previous or concurrent cancer that is distinct in primary site or histology from HCC. Any cancer curatively treated >3 years prior to entry is permitted; 6. Prior transarterial embolization or anti-tumor systemic chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression;Disease Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;untoward effect; | — |
Countries
China
Contacts
Public ContactWukui HUANG
The Afiliated Tumor Hospital of Xinjiang Medical University
Outcome results
None listed