Chemoembolization Using LifePearl Polyethylene Glycol Drug Eluting Microspheres With Doxorubicin … (NCT03734068) | Clinical Trial Compass
UnknownNot Applicable
Chemoembolization Using LifePearl Polyethylene Glycol Drug Eluting Microspheres With Doxorubicin in HCC
Italy100 participantsStarted 2018-06-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Tumor response
Timeframe: 6 months
Trial details
NCT IDNCT03734068
SponsorInternational Group of Endovascular Oncology