Clinical trial · Observational
Prospective, Multicenter HCCIS Evaluation Study
Prospective, Multicenter Study to Evaluate the HCCIS as Prognosticator for Overall and Disease-free Survival of Patients After Resection of HCC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Overall survival | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Overall survival HCCIS low risk
- description
- HCCIS 2 points
- interventionNames
- Other: Overall survival
- label
- Overall survival HCCIS medium risk
- description
- HCCIS 1 point
- interventionNames
- Other: Overall survival
- label
- Overall survival HCCIS high risk
- description
- HCCIS 0 point
- interventionNames
- Other: Overall survival
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available