E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PATIENTS WITH advanced hepatocellular carcinoma AND FUNCTIONALITY 'LIVER CHILD-PUGH B |
PAZIENTI CON EPATOCARCINOMA AVANZATO e FUNZIONALITA' EPATICA CHILD-PUGH B |
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E.1.1.1 | Medical condition in easily understood language |
PATIENTS WITH ADVANCED LIVER CANCER AND HEPATIC FUNCTIONALITY CHILD-PUGH B |
PAZIENTI CON TUMORE DEL FEGATO AVANZATO e FUNZIONALITA' EPATICA CHILD-PUGH B |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the objective response rate (RR) of the treatment |
Valutare il tasso di risposta obiettivo (RR) del trattamento |
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E.2.2 | Secondary objectives of the trial |
• 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. |
• Stabilire l’attività antitumorale della capeciabina metronomica in termini di tempo alla progressione (TTP) e sopravvivenza globale (OS);
• Valutare la tossicità e il profilo di sicurezza del trattamento;
• Analizzare l’impatto della capeciabina metronomica sulla qualità della vita (EORTC QLQ-C30). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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• Consenso informato scritto alla terapia;
• Diagnosi citologica o istologica di epatocarcinoma o valori di fetoproteina 200ng/ml con lesione radiologicamente suggestiva di epatocarcinoma;
• Epatocarcinoma avanzato non suscettibile di interventi chirurgici o loco-regionali (TACE, PEI);
• Almeno una lesione misurabile secondo i criteri RECIST;
• ECOG (Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
• Età ≥ 18 anni;
• Adeguata funzionalità renale (creatinina sierica ≤ 1.5 volte il limite superiore del range normale);
• Livelli di transaminasi fino a 5 volte i limiti normali;
• Livelli di bilirubina totale fino a 3 volte i limiti normali;
• Adeguata riserva midollare con globuli bianchi ≥ 3000/mmc (con neutrofili ≥1500/mmc), piastrine ≥ 50.000/mmc, emoglobina ≥ 10mg/dl;
• Child-Pugh stage per cirrosi B.
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E.4 | Principal 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). |
• Altre neoplasie concomitanti (escluse carcinoma della cervice uterina e carcinoma baso e squamocellulare della cute);
• Presenza di metastasi cerebrali;
• Presenza di varici esofagee sanguinanti;
• Più di 1 trattamento (> 1 trattamento) chemioterapico precedente. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the objective response rate (RR) of the treatment |
Valutare il tasso di risposta obiettivo (RR) del trattamento
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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.
|
• Stabilire l’attività antitumorale della capeciabina metronomica in termini di tempo alla progressione (TTP) e sopravvivenza globale (OS);
• Valutare la tossicità e il profilo di sicurezza del trattamento;
• Analizzare l’impatto della capeciabina metronomica sulla qualità della vita (EORTC QLQ-C30).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |