Hepatocellular Carcinoma
Conditions
Brief summary
With this prospective, multicenter trial the investigators aim to establish the Hepatocellular Immune Score (HCCIS), a score that has been developed in a retrospective study, as a new tool for risk stratification of patients after resection of hepatocellular carcinoma that can be widely used in the clinical practice. The investigators expect to show that this score is a prognosticator for overall survival and also disease free survival. Further, it should be demonstrated that the HCCIS is a risk stratification tool that is independent from clinical or descriptive parameters. Additionally, the investigators plan to elucidate that the respective HCCIS risk groups are not only different with respect to immunological infiltration but are also different with respect to tumor biology. The finding, that tumors of the respective risk groups show different tumor biology leads to the assumption that different therapy strategies need to be applied. Therefore, in a translational approach we aim to build up a data base with HCC tumor organoids and test the effect of CD8+IL-33+ effector-memory cells on HCC tumor organoids of the respective HCCIS risk groups.
Interventions
OTHEROverall survival
Observation of overall and disease free survival
Sponsors
Else Kröner Fresenius Foundation
University of Regensburg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.
Exclusion criteria
* Patients who have not given informed consent or who have withdrawn their consent will be excluded from this analysis. In case there is not enough liver tissue for a histological analysis or the remaining liver tissue is not enough to perform a routine pathological analysis patients have to be excluded from the further analysis. In case of an R1 or R2 resection, patients have to be excluded from further analysis. However, these patients will remain in the study as an intention to treat analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The HCC immune score (HCCIS) is a survival prognosticator of patients after liver resection for HCC | 3 years | Overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The HCC immune score (HCCIS) to prognosticate disease free survival of patients after liver resection for HCC | 3 years | Disease free survival |
Contacts
Primary ContactStefan M Brunner, MD
Outcome results
None listed