Hepatocellular Carcinoma Clinical Trial
— LIFDOXOfficial title:
Observational Prospective Study on Chemoembolization Using LifePearl Polyethylene Glycol Drug Eluting Microspheres With Doxorubicin in Patients With Primary Un-resectable Liver Cancer (Hepatocellular Carcinoma)
NCT number | NCT03734068 |
Other study ID # | LIFDOX |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 13, 2018 |
Est. completion date | December 2021 |
The aim of this study is to collect data on efficacy and tolerability on a large series of patient of different Italian hospitals in order to support the validation of LifePearl with robust and consistent clinical evidence. Since TACE in treating HCC is considered a more common and accepted approach, this study will be focused on evaluating treatment efficacy and safety of LIFDOX for un-resectable hepatocellular carcinoma.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with confirmed diagnosis of HCC with CT scan, MRI or biopsy - Patient with un-resectable HCC and not indicated for other radical therapies, or waiting for transplant - Multinodular or single nodular tumor extended to <50% of the liver - Hyper vascular lesion showing contrast enhancement in the early stage at the contrast media bolus injection 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 by the CT or MR - Eastern Cooperative Oncology Group performance status is 0 - 1 - Proper blood, liver, renal, heart function - Over 18 years old - Expected survival more than 6 months - Prior written patient consent Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Antonio Nicolini | Milano |
Lead Sponsor | Collaborator |
---|---|
International Group of Endovascular Oncology |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor response | CT scan will be performed to assess tumor response | 6 months | |
Secondary | Number of adverse events | number and intensity of adverse events will be monitored | 1 year | |
Secondary | time to progression | time from first treatment to progression will be computed | 1 months | |
Secondary | number of treatment required to achieve objective response in HCC patients | number of treatment required to achieve objective response (partial or complete response) will be recorded | 1 year |
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