Prospective, Multicenter HCCIS Evaluation Study

Hepatocellular Carcinoma Clinical Trial

— HCCIS  

Official title:

Prospective, Multicenter Study to Evaluate the HCCIS as Prognosticator for Overall and Disease-free Survival of Patients After Resection of HCC

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02718235
• Other study ID #: HCCIS16
• Status: Not yet recruiting
• Phase: N/A
• First received: March 5, 2016
• Last updated: March 23, 2016
• Start date: June 2016
• Est. completion date: June 2021

Study information

• Verified date: March 2016
• Source: University of Regensburg
• Contact: Stefan M Brunner, MD
• Phone: 00491711752911
• Email: stefan.brunner[@]ukr.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• Overall survival
Observation of overall and disease free survival

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Regensburg	Else Kröner Fresenius Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The HCC immune score (HCCIS) is a survival prognosticator of patients after liver resection for HCC	Overall survival	3 years	No
Secondary	The HCC immune score (HCCIS) to prognosticate disease free survival of patients after liver resection for HCC	Disease free survival	3 years	No