Intermediate hepatocellular carcinoma MedDRA version: 16.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: DC Bead
Product Name: DC Bead
Product Code: DEB
Pharmaceutical Form: Suspension for injection
Trade Name: Lipodol ultra fluide
Product Name: iodine
Pharmaceutical Form: Emulsion and suspe
Sponsors
Department of Pharmacy, Uppsala University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the plasma pharmacokinetics of doxorubicin and its active metabolite doxorubicinol after a single dose of doxorubicin-loaded DC bead or doxorubicin-lipiodol emulsion ;Secondary Objective: • To evaluate the anti-tumor effect defined as tumor size and amount of necrosis using magnetic resonance imaging (MRI) 4-6 weeks after a single dose of one these two formulations. • To evaluate safety (liver function and adverse events) of the two products after a single dose of one these two formulations. • To evaluate the urinary excretion of doxorubicin and doxorubicinol 24 hours after a single dose of one these two formulations.;Primary end point(s): Primary pharmacokinetic parameters: AUC, Cmax, tmax, t1/2 of doxorubicin and its active metabolite doxorubicinol in plasma from two sampling sites (vena cava and peripheral vein);Timepoint(s) of evaluation of this end point: PK parameters will be collected during 24 h after the performed treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary variables to be assessed: Secondary effect variables: Anti-tumor response of treated lesion Secondary safety variables: A complete physical examination in addition to adverse events caused by the study and abnormal, clinically relevant, laboratory parameters assessed by liver function tests and a-fetoprotein to assess biohumoral levels of the disease. Secondary pharmacokinetic variables: Fraction excreted of doxorubicin and doxorubicinol in urine;Timepoint(s) of evaluation of this end point: Secondary effect variables: at 4-6 weeks post treatment assessed with MRI according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Secondary safety variables: A complete physical examination will be performed at screening and at the end of the study (at 4-6 weeks, after MRI). Blood samples including aminotransferases, bilirubin, alkaline phosphatase, CRP, albumin, creatinine, urea, electrolytes, hemoglobin, leukocytes and thrombocytes will be taken at screening, and 24 hours and 5-7 days after treatment. Secondary pharmacokinetic variables: urine will be collected during the first 24 h after treatment. | — |
Countries
Sweden
Contacts
Public ContactBiopharmaceutical research group
Department of Pharmacy
Outcome results
None listed