DC Bead LUMI (TM) Loaded With Doxorubicin for Intermediate Hepatocellular Carcinoma (HCC)

Correlation of Necrosis With DC Bead LUMI (TM) Distribution

The primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Cancer; Chemoembolization
• Intervention / Treatment: Device: chemoembolization

Detailed Description

The primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled. Primary endpoint : Local response (evaluated with CT and MRI at 4 to 6 weeks post each procedure and at 6 months according to mRECIST) in patients with intermediate-stage HCC following chemoembolisation with radiopaque bead. Secondary endpoints include: 1) Better definition of end point of embolization for drug eluting beads : Ability to achieve near-stasis during chemoembolisation procedure in the tumour feeding vessels using intra-procedural imaging feedback from the radiopaque bead (early visualization of non target embolization 2) Total dose needed for tumor devascularization 3)Distribution of radiopaque beads and correlation with necrosis and adverse events

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 15538
      • Evgenidion Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with intermediate stage hepatocellular carcinoma (BCLC B)

Description

Inclusion Criteria:

1. Patient is at least 18 years old.
2. HCC diagnosed according to updated American Association for the Study of Liver Diseases (AASLD) criteria.
3. Barcelona Criteria Liver Cancer (BCLC) stage B patients or BCLC stage A patients not candidates for curative treatment (resection, transplantation, ablation) or who have failed/recurred after resection/ablation).
4. Tumour burden (located in one or two lobes) that can be sufficiently and selectively embolised with required dose or radiopaque bead loaded with doxorubicin.
5. Performance status: Eastern Cooperative Oncology Group (ECOG) status 0/1.
6. Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh A score and Child/Pugh B≤ 7 points ) without ascites.
7. Total bilirubin ≤2.0 mg/dl.
8. Adequate renal function (serum creatinine < 1.5 X ULN).
9. Patient has provided written informed consent.

Exclusion Criteria:

1. Patient previously treated with any intra-arterial therapy for HCC.
2. Eligible for curative treatment (resection/RadioFrequency Ablation-RFA, transplantation therapies).
3. Advanced liver disease: Child-Pugh's C class or active gastrointestinal bleeding, encephalopathy. Bilirubin levels >2.0 mg/dl.
4. Advanced tumoural disease: BCLC class C (vascular invasion -even segmental, extra-hepatic spread or cancer-related symptoms=ECOG of 1-2) or D class (WHO performance status 3 or 4, Okuda III stage).
5. Patient with another primary tumour.
6. Patient with refractory ascites or on diuretic treatment; minor ascites retention detected at imaging and not requiring diuretics to be solved is not a contraindication.
7. Patient with history of biliary tree disease or biliary dilatation.
8. Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated.
9. Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media).
10. Any other contraindication for embolisation or local doxorubicin treatment.
11. Patients currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before study treatment.
12. In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
13. Pregnant or breast-feeding women.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CORRELATION OF LUMI DISTRIBUTION WITH NECROSIS	Local response following chemoembolisation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Definition of end point of embolization for drug eluting beads	optimization of embolization	12 months
Total dose needed for tumor devascularization	dose required for tumor devascularization	12 months
Distribution of radiopaque beads and correlation with necrosis	correlation between imaging and tumor necrosis	12 months

Collaborators and Investigators

• Sponsor: Malagari Katerina
• Investigators: Principal Investigator: KATERINA MALAGARI, EVGENIDION HOSPITAL, ATHENS, GREECE

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2018
• Primary Completion (ACTUAL): January 5, 2022
• Study Completion (ACTUAL): January 5, 2022

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (ACTUAL): March 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: chemoembolization; drug eluting beads
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: IIS_Malagari Athens_BTG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: CT and MRI images will be stored anonymously by giving each patient a code number
• IPD Sharing Time Frame: starting February 2018 and ending February 2019
• IPD Sharing Access Criteria: the principal investigator and collaborator will record and analyse data from the CT and MRI of the patients. The names of the patients will not be in the examinations and identity will be given by enrollment number
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No