An open, multicenter, single dose, parallel study, evaluating the releaseand disposition of doxorubicin and its active metabolite (doxorubicinol)after an intra-arterial injection into the liver of an emulsion containingdoxorubicin or doxorubicin loaded into microparticulate beads in patientswith intermediate stage primary liver cancer.

Active, not recruiting

• Conditions: Intermediate hepatocellular carcinoma; MedDRA version: 16.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001244-56-SE
• Lead Sponsor: Department of Pharmacy, Uppsala University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-29
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adult (> 18 years),
2. Diagnosis of HCC: based on the Guidelines issued by AASLD
(American Association for the Study of Liver Diseases) (latest diagnostic
radiological imaging performed within 1 month from enrolment),
3. HCC for which transplantation, surgical resection or percutaneous
ablation are not indicated,
4. Child-Pugh class A or B,
5. Performance status: ECOG 0-2 (WHO),
6. Life expectancy of at least 3 months in absence of treatments,
7. The following laboratory parameters must be met:
Creatinine = 115 µmol/L, Bilirubin = 20.5 µmol/L, Albumin >= 35 g/L,
White blood cells >= 1.5 x 109/L, INR >= 1.7,
8. Signature of informed consent obtained from the patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

1. Infiltrative HCC,
2. Liver tumor is undefined, immeasurable or not assessable,
3. Portal vein thrombosis, with the exception of thrombosis of a
segment branch of the portal vein,
4. Extra-hepatic cancer involvement,
5. Contraindications to arteriography,
6. Use of doxorubicin and other anthracyclines in the last three months
prior to inclusion into the study,
7. Previous or ongoing transarterial chemoinfusion (TAI) and/or
chemoembolization (TACE) treatment of the same liver tumor (i.e. same
lobular or segmental target area),
8. Known or suspect hypersensitivity to the investigational drug or to
the investigational pharmacological class,
9. Ascites grade 2 or 3,
10. Patients presenting with severe clinical conditions which in the
opinion of the investigator contraindicate patient participation in the
study,
11. Presence of localized or systemic infections (with the exception of
HIV infection responsive to therapy, HBV and HCV),
12. Pregnant women (women of child-bearing potential will have a
pregnancy test done) and breastfeeding women,
13. Patients who are not capable of complying with the procedures
established by the protocol and of signing the informed consent. In case
of incapacitated patients unable to release their informed consent to
take part in the study, the consent must be released and signed also by
the parents/guardian or by the legal representative. Incapacitated
patients must as well sign the informed consent to the best of their
ability.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified