This single center, open-label, uncontrolled, non-randomized observational study in patients with advanced HCC. The patients qualify either to a local treatment with transarterial chemoembolization (TACE) or to a systemic treatment with the multikinase inhibitor sorafenib. The aim of this feasibility study is to get a comprehensive image and molecular fingerprint of individual tumors, with the intention to govern therapy decisions. Furthermore, to improve the care of patients that get progressive disease under treatment, the investigators have to improve the investigators understanding of the development of therapy resistance, which will improve patient care at the time point of progressive disease. Therefore, the data of 20 patients in each group will be used to identify molecular and / or image patterns, that can be used to predict treatment responses and thus govern an optimized individual cancer treatment for patients with advanced HCC.
A single-center, open-label, uncontrolled, non-randomized clinical trial. The two treatment groups to receive: Group A Transarterial Chemoembolization (TACE): 20 patients that are treated with TACE will get an image and molecular fingerprint of the tumor prior to the first treatment with TACE, a second image fingerprint between week 2 - 4 after the first treatment with TACE, and a third image and molecular fingerprint at the time point of progressive disease. Group B Sorafenib: 20 patients that are treated with Sorafenib will get an image and molecular fingerprint of the tumor prior to the first treatment, between week 2 and 3 after the start of treatment and at the time point of progressive disease.
Study Type
OBSERVATIONAL
Enrollment
25
This is an observational study that uses in depth diagnostic procedures to characterize patients with a comprehensive Image Fingerprint that includes CT, MRI and PET diagnostics
This is an observational study that uses in depth diagnostic procedures to characterize patients with a Molecular Fingerprint that includes next-generation sequencing
University Hospital
Tübingen, Baden-Wurttemberg, Germany
Availability of comprehensive imaging and molecular fingerprint data of individual tumors
The aim of this feasibility study is to get comprehensive image and molecular fingerprints of individual tumors that can be used for systems biology approaches to predict therapy outcome and govern therapeutic decisions.
Time frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months
Determination of turnaround time for image and molecular data availability
To set-up and optimize the workflow of data gathering and analysis for molecular and image fingerprints.
Time frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months
Description of correlations between image and molecular data
Correlation of results from image and molecular fingerprints at one point of time
Time frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months
Description of correlations between image and molecular data
Correlation of either image or molecular fingerprints at three different time points
Time frame: Each patient will be evaluated within six months, the whole study outcome will need 48 months
Identification of molecular and image patterns of treatment failure
To identify molecular and image patterns of early treatment failure.
Time frame: Each individual patient will be evaluated within six months, the whole study outcome will need 48 months
Identification of molecular and image patterns of treatment success
To identify molecular and image patterns of early treatment success
Time frame: Each individual patient will be evaluated within six months, the whole study outcome will need 48 months
Comparison of molecular and image pattern fingerprints in patients and animal models
To compare molecular and image patterns from HCC patients with respective patterns from different animal models which might identify suitable preclinical models for different clinical tumor patterns.
Time frame: Evaluation within 48 months
Identification of early outcome prediction patterns
To determine ideal imaging methods for an early prediction of progressive disease
Time frame: Evaluation within 48 months
To provide data for a molecular diagnostic board
To set up a molecular diagnostic board that checks for data-based tailored treatment options
Time frame: Each individual patient will be evaluated as soon as data sets are available within this feasibility study
Biomarker analysis
To identify clinical relevant biomarkers from tumor tissue or blood / urine analysis
Time frame: Evaluation within 48 months
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