Advanced Hepatocarcinoma MedDRA version: 9.1 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular
Conditions
Interventions
Trade Name: XELODA*120CPR RIV 500MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Capecitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologic proof of HCC or respect of Barcelona criteria No possibility of curative treatments (surgery, RF, TACE or PEI) Life expectancy > 3 months Child-Pugh stage A or B Total bilirubine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Severe cardiac or renal disease Women of child-bearing potential that refuse adequate contraceptive measures, no pregnancy or breast feeding Child-Pugh stage C History of hypersensitivity to 5-FU Administration of any sperimental chemotherapeutic agents within the last two months Any clinical conditions potentially hampering compliance with the study protocol Any psychological, familial, social or geographical conditions potentially hampering compliance with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of capecitabine administrated according to a metronomic schedule in advanced HCC;Secondary Objective: - Tolerability of metronomic capecitabine in advanced HCC and comparison to standard capecitabine.;Primary end point(s): TTP time to progression | — |
Countries
Italy
Outcome results
None listed