Prospective, Multicenter HCCIS Evaluation Study

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: Overall survival

• Registration Number: NCT02718235
• Lead Sponsor: University of Regensburg

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-05
• Study First Submitted QC: 2016-03-23
• Last Update Submitted: 2016-03-23
• Study First Posted: 2016-03-24
• Last Update Posted: 2016-03-24
• Study Start: 2016-06
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients >18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.

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• Patients who have not given informed consent or who have withdrawn their consent will be excluded from this analysis.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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overall survival HCCIS low risk	Overall survival	HCCIS 2 points
Overall survival HCCIS medium risk	Overall survival	HCCIS 1 point
Overall survival HCCIS high risk	Overall survival	HCCIS 0 point

Primary Outcome Measures

Name	Time	Method
The HCC immune score (HCCIS) is a survival prognosticator of patients after liver resection for HCC	3 years	Overall survival

Secondary Outcome Measures

Name	Time	Method
The HCC immune score (HCCIS) to prognosticate disease free survival of patients after liver resection for HCC	3 years	Disease free survival