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

NCT03474354 | Completed DMC

• 1 other identifier: IIS_Malagari Athens_BTG
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Cancer; Chemoembolization

Keywords

chemoembolization; drug eluting beads

Outcome Measures

Primary Outcomes (1)

• CORRELATION OF LUMI DISTRIBUTION WITH NECROSIS

  Local response following chemoembolisation

  12 months

Secondary Outcomes (3)

• Definition of end point of embolization for drug eluting beads

  12 months

• Total dose needed for tumor devascularization

  12 months

• Distribution of radiopaque beads and correlation with necrosis

  12 months

Interventions

chemoembolization DEVICE

correlation of necrosis with the deposition of beads

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with intermediate stage hepatocellular carcinoma (BCLC B)

You may qualify if:

• Patient is at least 18 years old.
• HCC diagnosed according to updated American Association for the Study of Liver Diseases (AASLD) criteria.
• 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).
• Tumour burden (located in one or two lobes) that can be sufficiently and selectively embolised with required dose or radiopaque bead loaded with doxorubicin.
• Performance status: Eastern Cooperative Oncology Group (ECOG) status 0/1.
• Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh A score and Child/Pugh B≤ 7 points ) without ascites.
• Total bilirubin ≤2.0 mg/dl.
• Adequate renal function (serum creatinine \< 1.5 X ULN).
• Patient has provided written informed consent.

You may not qualify if:

• Patient previously treated with any intra-arterial therapy for HCC.
• Eligible for curative treatment (resection/RadioFrequency Ablation-RFA, transplantation therapies).
• Advanced liver disease: Child-Pugh's C class or active gastrointestinal bleeding, encephalopathy. Bilirubin levels \>2.0 mg/dl.
• 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).
• Patient with another primary tumour.
• 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.
• Patient with history of biliary tree disease or biliary dilatation.
• Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated.
• Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media).
• Any other contraindication for embolisation or local doxorubicin treatment.
• 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.
• 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.
• Pregnant or breast-feeding women.

Sponsors & Collaborators

• Malagari Katerina: lead

Study Sites (1)

Evgenidion Hospital

Athens, Attica, 15538, Greece

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Chemoembolization, Therapeutic

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• KATERINA MALAGARI

  Evgenidion Hospital Athens, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 22, 2018
• Study Start: May 2, 2018
• Primary Completion: January 5, 2022
• Study Completion: January 5, 2022
• Last Updated: January 6, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: starting February 2018 and ending February 2019
• 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

Locations

GR (1)