E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Liver Cancer |
Hepatocellular cancer |
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E.1.1.1 | Medical condition in easily understood language |
Liver Cancer |
cancro al fegato |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024722 |
E.1.2 | Term | Liver, cancer of, primary |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
Evaluate overall survival in patients treated with HepaSphere/QuadraSphere compared to conventional transarterial chemoembolization with particle PVA |
Valutare la sopravvivenza complessiva nei pazienti trattati con HepaSphere / QuadraSphere Rispetto ai tradizionali particelle transarteriosa con chemioembolizzazione PVA |
|
E.2.2 | Secondary objectives of the trial |
Evaluate adverse events in patients treated with HepaSphere/QuadraSphere compared to those treated with conventional transarterial chemoembolization with particle PVA |
Valutare gli eventi avversi nei pazienti trattati con HepaSphere / QuadraSphere rispetto a quelli trattati con i tradizionali chemioembolizzazione transarteriosa con particelle PVA. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a. Age 18 or older b. Patient has signed informed consent c. Patient must have a diagnosist of hepatocellular cancer confirmed by at least one of the following: -histological confirmation -MRI result consistent with cirrhosis AND at least one solid liver lesion >2 cm with early enhancement and delayed enhancement washout, regardless of apha fetoprotein level -Alpha fetoprotein level >400 ng/mL AND evidence of at least one solid lesion >2 cm, regardless of specific imaging characteristics on MRI d. Patient must not be suitable for treatment by resection or percutaneous albation at time of study entry. Patients not suitable for ablation due to lesion location may be enrolled e. Patient MUST meet at least ONE of the following criteria: -Stage Child-Pugh B 7 -Recurrent HCC -Performance status ECOG 1 f. Patient has a life expectancy of at least 6 months g. Absence of occlusive thrombus to the main portal trunk |
uno. Eta' 18 anni b. Il paziente ha firmato c consenso informato. Il paziente deve avere una diagnosi di tumore epatocellulare confermata da almeno uno dei seguenti:-la conferma istologica-MRI risultato coerente con cirrosi e almeno una lesione solida al fegato> 2 centimetri, con la valorizzazione precoce e washout delayed enhancement, a prescindere dal livello di alphafetoprotein-alfa fetoproteina livello> 400 ng / mL e la prova di almeno una lesione epatica solido> 2 cm, indipendentemente dalle caratteristiche specifiche di imaging in risonanza magnetica d. Il paziente non deve essere adatto per la resezione o ablazione percutanea al momento dell'ingresso nello studio. I pazienti non adatti per l'ablazione a causa della posizione della lesione e possono essere iscritti. Il paziente deve soddisfare almeno uno dei seguenti criteri: - Stage Pugh B 7 - HCC Recurrent - performance status ECOG 1 f. Il paziente ha un'aspettativa di vita di almeno 6 g mesi. Assenza di trombo occlusvie al tronco portale principaleUndo edits |
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E.4 | Principal exclusion criteria |
a. Current or previous treatment with chemo or radiation therapy or sorafenib b. Previous treatment with any form of transarterial embolization for HCC c. Patients with current or history of any other cancer except nonmelanomatous skin cancer d. Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive e. Performance status ECOG>2 f. Child-Pugh score >7 g. Active gastroinstestinal bleeding h. Evidence of uncorrectable bleeding diathesis i. Extrahepatice spread of the HCC j. Total Bilirubin >3mg/dL k. >50% tumor involvement of the liver l. Infiltrative or diffuse HCC m. Encephalopathy not adequately controlled medically. n. Prescence of ascites not controlled medically. o. Presence of medically relevant localized or systemic infection,other than hepatitis B,C,D,E or G p. Any contraindication for MRI q. Allergy to contrast media that cannot be managed with prophylaxis r. Allergy to iodized oit s. Any contraindication to arteriography t. Any contraindication for doxorubicin administration, including the following: -White blood cell count <3000 cells/mm -Absolute Neutrophil <1500 cells/mm -Cardiac ejection fraction <50% -Other condition deemed exclusionary by physician u. Any contraindication for hepatic embolization, including the following: -Porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization -Hepatofugal blood flow -Serum creatinine >2mg/dL -Uncorrectable impaired clotting 1. Platelet <50000/mm 2. International Normalized Ratio (INR)>1.4 3. aPTT outside normal limits - AST >5x upper limit of normal for lab - ALT >5x upper limt of normal for lab -Severe peripheral vascular disease -Other condition demmed exclusionary by physician |
uno. Il trattamento attuale o precedente con la terapia chemio o radioterapia o b sorafenib. Un precedente trattamento con qualsiasi forma di embolizzazione transarteriosa per HCC c. Pazienti con storia di corrente o qualsiasi altro cancro, tranne d nonmelanomatous cancro della pelle. Pazienti di sesso femminile che sono in stato di gravidanza, l'allattamento o in premenopausa e non utilizzando un metodo efficace e contraccettivi. Performance status ECOG> 2 f. Child-Pugh score> 7 g. Attivo gastroinstestinal sanguinamento h. La prova di non correggibile diatesi emorragica i. Extrahepatice diffusione del j HCC. Bilirubina totale> 3mg/dL k. > Tumorale 50% della L fegato. Infiltrativa o diffusa HCC m. Encefalopatia non adeguatamente controllati medico. n. Prescence di ascite non controllata medico. o. Presenza di clinicamente rilevante infezione localizzata o sistemica, oltre epatite B, C, D, E o G p. Qualsiasi controindicazione per MRI q. Allergia ai mezzi di contrasto che non possono essere gestiti con la profilassi r. Allergia al iodato oit s. Eventuali controindicazioni alla t arteriografia. Alcuna controindicazione per la somministrazione doxorubicina, tra cui le seguenti:-numero dei globuli bianchi <3000 cellule / mm assoluta dei neutrofili <1500 cellule / mm-Cardiac frazione di eiezione <50%-Other condizioni ritenute di esclusione da u medico. Qualsiasi controindicazione per embolizzazione epatica, inclusi i seguenti:-Porto-shunt sistemico, o un shunt artero-che non puo' essere adeguatamente chiusa prima chemioembolizzazione-Hepatofugal il flusso di sangue-La creatinina sierica> 2mg/dL-non correggibile compromessa 1 coagulazione. Piastrinica <50000/mm 2. International Normalized Ratio (INR)> 1.4 3. aPTT al di fuori dei limiti normali - AST> 5 volte il limite superiore del valore normale per il laboratorio - LIMT ALT> 5 volte superiore del valore normale per i lab-grave della malattia vascolare periferica-Altro dannata condizione di esclusione dal medico |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary study endpoint will be overall survival. |
L'endpoint primario dello studio sara' la sopravvivenza globale. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Tumor response by mRECIST criteria Overall tumor response Treatment related to adverse events |
La risposta tumorale da mRECIST trattamento criteri generali risposta del tumore in rapporto ad eventi avversi |
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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 | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
lipiodol and doxorubicin |
lipiodol and doxorubicin |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
European Union |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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
|
Patients will be followed from date of first embolization cycle to date of death is obtained or patient is lost to followup. Survival attempts will be attempted every 3 months after completion or final protocol specified study visit. End of trial will be when last patient dies. |
Patients will be followed from date of first embolization cycle to date of death is obtained or patient is lost to followup. Survival attempts will be attempted every 3 months after completion or final protocol specified study visit. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |