Clinical trial · Observational
Chemoembolization Using LifePearl Polyethylene Glycol Drug Eluting Microspheres With Doxorubicin in HCC
Observational Prospective Study on Chemoembolization Using LifePearl Polyethylene Glycol Drug Eluting Microspheres With Doxorubicin in Patients With Primary Un-resectable Liver Cancer (Hepatocellular Carcinoma)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoembolization Using LifePearl | Device | — | UNRESOLVED |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Chemoembolization
- description
- Chemoembolization Using LifePearl and Doxorubicin
- interventionNames
- Device: Chemoembolization Using LifePearl
- Drug: Doxorubicin
Primary outcomes (1)
- measure
- Tumor response
- timeFrame
- 6 months
- description
- CT scan will be performed to assess tumor response
Secondary outcomes (3)
- measure
- Number of adverse events
- timeFrame
- 1 year
- description
- number and intensity of adverse events will be monitored
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available