Clinical trial NCT02718235: Prospective, Multicenter HCCIS Evaluation Study
Official title: Prospective, Multicenter Study to Evaluate the HCCIS as Prognosticator for Overall and Disease-free Survival of Patients After Resection of HCC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Lead sponsor: University of Regensburg
Sponsor class: OTHER
Collaborators: name: Else Kröner Fresenius Foundation
First posted: 2016-03-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \>18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.

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.


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* Patients who have not given informed consent or who have withdrawn their consent will be excluded from this analysis.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

Primary outcomes:
measure: The HCC immune score (HCCIS) is a survival prognosticator of patients after liver resection for HCC
timeFrame: 3 years
Secondary outcomes:
measure: The HCC immune score (HCCIS) to prognosticate disease free survival of patients after liver resection for HCC
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Surgery, University Medical Center Regensburg, Regensburg, Germany
name: Stefan M Brunner, MD
role: PRINCIPAL_INVESTIGATOR
References: