Prospective, Multicenter HCCIS Evaluation Study

University of Regensburg (UR)

Status

Unknown

Conditions

Hepatocellular Carcinoma

Treatments

Other: Overall survival

Study type

Observational

Funder types

Other

Identifiers

NCT02718235

HCCIS16

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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Patients who have not given informed consent or who have withdrawn their consent will be excluded from this analysis.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.