C22.0
Conditions
Interventions
Group 1: Patients with hepatocellular carcinoma and treatment with sorafenib receive a comprehensive image and molecular tumor characterization ("Image and Molecular Fingerprint")
Sponsors
Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.HCC patients with indication for the treatment with a tyrosine kinase inhibitor (TKI), irrespective of previous systemic therapies. 2.If prior systemic therapies had been applied, progression has to be documented prior to the start of treatment with the TKI. 3.Male or female = 18 years and written informed consent. 4.Histologically confirmed advanced stage hepatocellular carcinoma, BCLC class B or C. 5.Child-Pugh class A or B. Only patients with Child-Pugh index class B of not more than 7 will be included. Patients with untreatable ascites or hepatic encephalopathy > Grade 1 are excluded (see exclusion criteria). 6.ECOG performance status 0, 1 or 2. 7.Life expectancy of 12 weeks or more. 8.At least one measurable lesion without previous local therapy and that is suitable for accurate repeated measurements as per mRECIST guidelines. 9.Adequate hematological parameters, as demonstrated by: 10.Hemoglobin = 9.0 g/dl (SI units: 5.6 mmol/l); 11.WBC = 2.5 x 109/l; 12.Platelets = 60 x 109/l; 13.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5 times upper limit of normal range (ULNR); 14.Bilirubin = 3 mg/dl; 15.Serum creatinine = 1.5 mg/dl (SI units: 132 µmol/l); 16.Prothrombin Time (PT) International Normalized Ratio (INR) = 1.5.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are not eligible for study participation: 1.Renal failure requiring hemo- or peritoneal dialysis. 2.Patients with no adequate treatment for gastrointestinal bleeding and esophagus varices within 14 days prior to study entry. 3.Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy > Grade I. 4.Altered mental status precluding understanding of the informed consent process. 5. Pregnancy or breastfeeding mother.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To prospectively evaluate clinically available image and / or molecular fingerprint analysis of HCC tumor tissue to predict therapy responses. | — |
Secondary
| Measure | Time frame |
|---|---|
| •Time needed to determine parameter based prediction of therapy outcome for single parameters and for multiscale modelling. •Progression free survival (PFS). •Radiologically determined time to tumor progression (TTP). •Objective response rate (ORR) as measured by the sum of partial and complete responders. •Duration of tumor stabilization (CR, PR, SD). •Overall survival (OS). •To prospectively assess patient-reported outcome of HCC patients under treatment with sorafenib. •Distribution of sorafenib adverse drug reactions. •Feasibility of circulating miRNA Analysis, radiomics analysis and ultrasound elastography. | — |
Countries
Germany
Contacts
Public ContactUrsula Koppenhöfer
Medizinische UniversitätsklinikEberhard Karls Universität Tübingen
Outcome results
None listed