SP 5

Interventional clinical trial to test 3D-multiscale HCC model derived decisions in human patients with HCC

In Subproject 5, two clinical trials are conducted throughout the lifetime of the consortium. Currently, an observation study (ClinicalTrials.gov Identifier: NCT02372162) is recruitung patients. This study was designed in the first year and patients have been recruited since July 2015. Patients undergoing either Sorafenib or transarterial chemoembolisation (TACE) can be included and are expected to contribute to the optimization of system biology models by the recorded “image fingerprint” and “molecular fingerprint” analysis. Interestingly, patients have already been included in this model, who either developed rapid progress under therapy or had an excellent response to Sorafenib. By comparing patterns in the individual "fingerprint" analyses together with preclinical and clinical data from the consortium, it shall be possible to identify predictive factors to guide therapy in advanced HCC.

In patients with progress under therapy an additional "fingerprint" analysis to identify patterns of resistance will also be included in the predictive system biology model. As a goal of this work and in connection with the analysis of clinical data from Subproject 1, as well as the preclinical models of the entire project, another clinical study is to be designed and initiated, which in the form of an intervention study evaluates the value of a new kind of prediction model for therapy recommendations in advanced HCC.

Keywords: HCC (hepatocellular carcinoma); therapy with Sorafenib; Volume Perfusion CT (VPCT); transarterial chemoembolization (TACE), PET-MRT, molecular diagnostics.