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Observational Prospective Study on Chemoembolization Using Doxorubicin Drug-eluting Bead in Patients With Unresectable Hepatocellular Carcinoma - DEBDOX

Studio Clinico

Patologia: Epatocarcinoma

Osservazionale-Sperimentale: Osservazionale

Monocentrico-Multicentrico: Monocentrico

Randomizzato: No

Fase di studio: Non applicabile

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Patients with confirmed diagnosis of HCC
- Patient with HCC not suitable for radical therapies such as resection, liver transplantation or percutaneous therapies or patient is indicated for these therapies but there is a contraindication for them or patient rejects the above treatments
- Multinodular or single nodular tumor more than 5cm
- Hypervascular lesion showing contrast enhancement in the early stage after contrast media injection during CT or MRI.
- At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by CT-scan or MRI
- No invasion in the blood vessel (hepatic portal, hepatic vein) or bile duct
- Eastern Cooperative Oncology Group performance status is 0 - 1
- Proper blood, liver, renal, heart functionality
- More than 18 years old
- Expected survival more than 6 months
- Prior written consent

Criteri di esclusione: 

- Extrahepatic metastasis (Any lymph nodes measuring ≥ 10mm along the short axis)
- Tumor burden involving more than 50% of the liver
- History of biliary tract repair or endoscopic biliary tract treatment
- Clinically important refractory ascites or pleural fluid
- Any contraindications for hepatic embolization procedures
- Any contraindication for doxorubicin administration
- Contrast media allergy contraindicating angiography
- Acute or active cardiac, hepatic or renal diseases
- Pregnant, nursing or childbearing age women and men who are sexually active and don't want to or can't do contraception

Trattamento sperimentale: 

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Trattamento di controllo: 

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Obiettivi primari dello studio: 

This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.
Primary objective: to collect data on tumor response after administration of drug-eluting microspheres that were preloaded with doxorubicin.

Obiettivi secondari dello studio: 

To collect data on survival rate, time to progression, tolerability of treatment, number of treatment required to achieve objective response and improvement of quality of life,

Centri partecipanti

Centro Italia

Ospedale S. Salvatore
Via Lombroso 1 - 61122 Pesaro - PU

Riferimento: Prof. Giammaria Fiorentini
Telefono: 0721364005
Email: giammaria.fiorentini@ospedalimarchenord.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT01891539

Data di inserimento: 16.07.2019

Promotore

International Group of Endovascular Oncology

CRO

NA

Principal Investigator ITALIA

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore, Pesaro

Riferimento: Prof. Giammaria Fiorentini

Telefono: 0721364005

Email: giammaria.fiorentini@ospedalimarchenord.it

Localita: Pesaro

 

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