Hepatocellular cancer
Conditions
Interventions
Trade Name: Doxorubicin Rapid Dissolution
Product Name: Doxorubicin
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Doxorubicin
Sponsors
Research and Enterprise, University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Fulfil criteria for diagnosis of HCC: At least one of the following need to be met for diagnosis I. Liver mass with histological confirmation of biopsied sample II. Liver mass with AFP>500 III. Liver mass with evidence of chronic Hepatitis C with or with out cirrhosis 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Extensive disease a. Multi-focal disease of greater than 4 lesions in either lobe b. Metastatic disease 2. Renal failure: GFR30, Bilirubin1.2 administer 10mg vitamin K needs to be 2 6. Presence of vascular invasion-(including segmental portal obstruction) 7. Contraindication to Doxorubicin: a. Ejection fraction<50% b. Hypersensitivity to hydroxybenzoates c. Buccal ulceration 8. Portosystemic shunt i.e. for oesophageal varicies, 9. GI bleed 10. Severe artheromatosis 11. Previous biliary surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : To compare DOX pharmacokinetics and subsequent rates of myelosuppression between DC Bead CEM and conventional CEM ; Secondary Objective: Secondary objectives : To perform proteomics on serum samples before and after Gel Sphere CEM, conventional CEM and systemic DOX ; Primary end point(s): Pharmacokinetics: Doxorubicin AUC and Cmax for both forms of chemoembolisation Pharmacodynamics: Neutrophil nidar Proteomics: Change in the proteome following chemoembolisation | — |
Countries
United Kingdom
Outcome results
None listed