The optimal treatment modalities or sequences for liver cancer are often not clearly defined and the methods used in individual cases depend heavily on the expertise of the respective center. In addition, the presence of an underlying liver disease and its influence on liver function often plays a decisive role in the applicable treatment options. A large number of patients are treated at the six participating Bavarian university hospitals. In order to collect structured data on patient and tumor characteristics as well as on therapies, highly complex data matrices are required for HCC and BTC due to the complexity of treatment, follow-up care and the risk of recurrence.

The main objective is to establish a data integration platform for the detailed collection of disease-specific data from patients with a first diagnosis of primary liver cancer. The data collected will form the basis for optimizing therapy concepts in the treatment of primary liver cancer (HCC and BTC) for all patients treated at the 6 Bavarian sites. By 2024, a data integration platform for HCC could be successfully established at all participating sites with the inclusion of patients with detailed recording of patient-specific risk factors, disease stage and therapy sequences as well as quality of life before and during therapy. A database for BTC is currently being set up and will provide important insights into the possibilities - and limitations - of individualized therapeutic approaches, particularly due to the high relevance of individually varying genetic changes for the treatment of BTC.
The aim of the databases is to screen and, following consent, include all patients with a first diagnosis of the corresponding tumor entity at the six Bavarian university hospitals. The analysis of such large databases of liver cancer patients will form the basis for the creation of prospective studies, including biomarker studies and clinical trials, involving all six BZKF centers.

Milestones to date:

• In a first step, a web-based database of the already established bitcare system for HCC with ADT data (Admission, Discharge, Transfer) including general patient data, tumor-specific data, data on tumor therapies and therapy response, data on liver function at initial presentation and during the course of therapy and data on quality of life at defined time points was set up and a broad consent form ("Broad Consent") was developed.
• The inclusion of HCC patients could be started at all six university hospitals and preliminary analyses of patient-specific characteristics at first diagnosis could already be carried out based on the data collected so far.
• In order to use detailed radiological data of the tumors, a consolidation of the detailed clinical HCC data with the HCC data set of the BORN project was planned. An initial test for the technical merging of the data has already been successfully completed.
• In addition to the data collection that has been started, two clinical studies were planned and started in the liver tumor study group and a retrospective analysis of adverse effects of HCC system therapy was completed:
  • HOMIE-166: Radioembolization of HCC with holmium^(166Ho), 5 BZKF centers, (lead: Jens Ricke, LMU): planning, initiation of study centers and start of recruitment.
  • MONTBLANC: Study on systemic first-line therapy of HCC (Head: Enrico de Toni, Alexander Philipp, Najib Ben Khaled, LMU): Initiation and recruitment
  • Retrospective analysis: Bleeding and thombembolic events after systemic HCC therapy (Head: Florian Reiter, WÜ): completed and published

Future milestones:

• Expansion of the data collection of HCC patients at all six Bavarian university hospitals with analysis and publication of patient-specific risk factors after reaching a sufficiently large number of patients
• Establishment of the data platform for the BTC and start of recruitment at all 6 BZKF centers.
• Expansion of the consolidation of structured radiological data for HCC with clinical data at initial tumor diagnosis and during the course of therapy to identify prognosis-determining radiological markers (collaboration with the BORN project)
• Establishment of biobanking of tumor and blood samples in the context of clinical HCC studies using the infrastructure of the biobanks.