METRONOMIC CAPECITABINE IN ADVANCED HEPATOCARCINOMA:A FASE II STUDY - Capemetro

• Conditions: Advanced Hepatocarcinoma; MedDRA version: 9.1Level: LLTClassification code 10049010Term: Carcinoma hepatocellular

• Registration Number: EUCTR2008-002299-92-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 < 3 mg/dl
Adequate bone marrow function
Adequate renal and cardiac function
Written informed consent
Child-Pugh A o B Bilirubina totale < 3 mg/dl
Adeguata riserva midollare
Adeguata funzionalita' renale e cardiaca
Consenso informato scritto
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified