Proteomics and Pharmacokinetics of Adriamycin Following Different Techniques for Chemoembolisation of Hepatocellular Carcinoma (PPATCH) Trial - PPATCH

Phase 1

• Conditions: Hepatocellular cancer

• Registration Number: EUCTR2005-000163-25-GB
• Lead Sponsor: Research and Enterprise, University of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-05-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

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

1.Extensive disease
a.Multi-focal disease of greater than 4 lesions in either lobe
b.Metastatic disease
2.Renal failure: GFR<60
3.Liver Function: No history of Encephalopathy, No ascites not easily medically controlled, Albumin>30, Bilirubin<50, If INR>1.2 administer 10mg vitamin K needs to be <1.5 to proceed
4.FBC: WCC<3.0, Neutophils<1.5, platelets<60
5.Performance status >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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: Main objective : <br> To compare DOX pharmacokinetics and subsequent rates of myelosuppression between DC Bead CEM and conventional CEM<br> <br> ;<br> Secondary Objective: Secondary objectives :<br> To perform proteomics on serum samples before and after Gel Sphere CEM, conventional CEM and systemic DOX<br> ;<br> Primary end point(s): Pharmacokinetics: Doxorubicin AUC and Cmax for both forms of chemoembolisation<br> Pharmacodynamics: Neutrophil nidar<br> Proteomics: Change in the proteome following chemoembolisation<br>