Status:
UNKNOWN
Observational Prospective Study on Chemoembolization With Doxorubicin for Unresectable Hepatocellular Carcinoma
Lead Sponsor:
International Group of Endovascular Oncology
Conditions:
Liver Cell Carcinoma Non-resectable
Eligibility:
All Genders
18-80 years
Brief Summary
Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the seventh in women and is the third most common cause of death from cancer worldwide. The overall incidence of HCC r...
Detailed Description
This study's purpose is to assess treatment efficacy, survival rate and safety of TACE using drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma. Study Design:...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01891539
Start Date
May 1 2013
End Date
December 1 2021
Last Update
February 27 2019
Active Locations (1)
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1
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore
Pesaro, PU, Italy, 61122