Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation

Lead Sponsor:

Boston Scientific Corporation

Collaborating Sponsors:

Biocompatibles UK Ltd

Conditions:

Primary Liver Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The objective of this study is to assess the safety and efficacy of DC Bead™ delivered by intra-arterial embolisation for the treatment of Hepatocellular Carcinoma

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • Patients with a confirmed diagnosis of HCC according to the EASL criteria for diagnosis, see appendix 4 and staged according to the BCLC criteria.
  • Patient chooses to participate and has signed the informed consent document
  • Age above 18 years old
  • Patients with HCC not suitable for resection or percutaneous ablation according to the BCLC Staging classification, see Figure 2.
  • Patient is eligible for resection or percutaneous ablation but the treatment is unfeasible or the patient has declined. This decision must be documented in the patient's records.
  • Patient is eligible for chemoembolisation prior to transplantation and the expected transplant waiting time exceeds 6 months.
  • Patients who demonstrates recurrence following potentially curative treatment (resection and percutaneous ablation) who have clearly measurable disease according to RECIST or EASL
  • Patients with Performance Status ECOG 0 and 1
  • Patients with well preserved liver function (Child-Pugh A and B)
  • Patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3 weeks.
  • Exclusion criteria
  • Patients with another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
  • Patients previously treated with transarterial embolisation (with or without chemotherapy).
  • Patients previously treated with anthracyclines (ie doxorubicin).
  • Patients' whose only measurable disease is within an area of the liver previously subjected to radiotherapy.
  • Advanced liver disease:
  • Child-Pugh C,
  • active gastrointestinal bleeding,
  • encephalopathy or clinically relevant ascites.
  • Bilirubin levels \>3mg/dl
  • Advanced tumoural disease:
  • BCLC class C, (vascular invasion including segmental portal obstruction, extrahepatic spread or cancer-related symptoms= ECOG 2, 3 and 4) or
  • BCLC class D (WHO performance status 3 or 4, Okuda III stage) or
  • Diffuse HCC defined as \>50% tumour involvement of the whole liver
  • Any contraindication for doxorubicin administration:
  • serum bilirubin \>5mg/dL,
  • WBC \<3000 cells/mm3
  • neutrophil \<1500 cells/mm3,
  • cardiac ejection fraction \<50 percent assessed by isotopic ventriculography, echocardiography or MRI
  • Any contraindication for hepatic embolisation procedures:
  • porto-systemic shunt,
  • hepatofugal blood flow;
  • impaired clotting tests (platelet count \<50000/mm3, prothrombin activity \<50 percent),
  • renal insufficiency/failure, serum creatinine \> 2mg/dl (177umol/l)
  • severe atheromatosis,
  • AST and/or ALT \>5x ULN or, when greater \>250U/l
  • Women who are pregnant or breast feeding
  • Allergy to contrast media
  • Contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation
  • The availability of alternative therapies those, in the judgment of the physician (referring or treating), are more appropriate for the patient
  • Any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk, that would preclude the safe use of DC Bead™, or TACE
  • Patients who are contraindicated for MRI

Exclusion

    Key Trial Info

    Start Date :

    November 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2008

    Estimated Enrollment :

    212 Patients enrolled

    Trial Details

    Trial ID

    NCT00261378

    Start Date

    November 1 2005

    End Date

    January 1 2008

    Last Update

    July 21 2021

    Active Locations (17)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (17 locations)

    1

    Medizinische Universitat Innsbruck

    Innsbruck, Austria, 6020

    2

    Allgemines Krankenhaus Vienna

    Vienna, Austria, 1090

    3

    L'Hopital Beaujon

    Clichy, France, 92100

    4

    Hopital Claude Huriez

    Lille, France, 59037