XELODA metronomic IN PATIENTS WITH advanced hepatocellular carcinoma AND FUNCTIONALITY 'LIVER CHILD-PUGH B

XELODA metronomic IN PATIENTS WITH advanced hepatocellular carcinoma AND FUNCTIONALITY 'LIVER CHILD-PUGH B - EPAX

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001483-39-IT

Enrollment

Registered

2014-01-15

Start date

2014-03-06

Completion date

Unknown

Last updated

2014-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PATIENTS WITH advanced hepatocellular carcinoma AND FUNCTIONALITY 'LIVER CHILD-PUGH B

Interventions

Trade Name: XELODA Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Written informed consent to treatment; • Cytologic or histologic diagnosis of HCC or values of alphafetoprotein = to 200 ng/ml with lesion radiologically suggestive for hepatocellular carcinoma; • Advanced Hepatocellular Carcinoma not susceptible to surgical or locoregional (TACE, PEI) treatment; • At least one measurable lesion according to RECIST criteria; • • ECOG (Eastern Cooperative Oncology Group (ECOG) performance status = 2; • Age = 18 years; • Adequate renal function (serum creatinine = 1.5 times the upper limit of the normal range); • transaminase levels up to 5 times the upper normal limits; • Levels of total bilirubin up to 3 times the upper normal limits; • Adequate bone marrow reserve with WBC = 3000/mmc (= 1500/mmc with neutrophils), platelets = 50.000/mmc, hemoglobin = 10mg/dl; • Child-Pugh B cirrhosis 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 43 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Gravi malattie sistemiche concomitanti (infezioni gravi, malattie cardiache, malattie renali, malattie immunitarie). • Other concomitant malignancy (except cervical carcinoma and basal cell carcinoma and squamous cell carcinoma of the skin); • Presence of brain metastases; • Presence of bleeding oesophageal varices; • More than 1 treatment (> 1 treatment) prior chemotherapy; • Serious concomitant systemic illness (serious infections, heart disease, kidney disease, immune disorders).

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the objective response rate (RR) of the treatment;Secondary Objective: • To evaluate antitumor activity in terms of time to progression (TTP) and overall survival (OS); • to assess toxicity and safety profile of the therapy; • to analyze the impact of the therapy on patient's quality of life.;Primary end point(s): To evaluate the objective response rate (RR) of the treatment;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Main Objective: To evaluate the objective response rate (RR) of the treatment;Secondary Objective: • To evaluate antitumor activity in terms of time to progression (TTP) and overall survival (OS); • to assess toxicity and safety profile of the therapy; • to analyze the impact of the therapy on patient's quality of life.;Primary end point(s): To evaluate the objective response rate (RR) of the treatment;Timepoint(s) of evaluation of this end point: 2 years

—

Secondary

Measure	Time frame
Secondary end point(s): • To evaluate antitumor activity in terms of time to progression (TTP) and overall survival (OS); • to assess toxicity and safety profile of the therapy; • to analyze the impact of the therapy on patient's quality of life. ;Timepoint(s) of evaluation of this end point: 3 years	—

Countries

Italy

Contacts

Public ContactOncologia Medica 1

Istituto Oncologico Veneto

oncologia1@ioveneto.it390498215704

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026