Blood and tissue sample: Prospective collection of additional blood and tissue samples for study-specific analyses at specific timepoints, at the same time as routine procedures.
Study summary
This project targets patients with a form of primary liver cancer, specifically "hepatocellular carcinoma". This disease often develops in the context of a chronically diseased liver, caused by viral infections, excessive alcohol consumption, or fatty liver. Primarily due to the rise of the latter risk factor, liver cancer is one of the few cancer types whose incidence continues to increase globally, year after year. As a result, liver cancer has become the third most common cause of cancer-related deaths worldwide. There exists a significant challenge in reducing the disease on all fronts: prevention, diagnosis, and treatment.
This research aims to personalize the treatment of liver cancer patients, tailoring it to the individual. More specifically, this research seeks to identify patients with immunotherapy-sensitive liver cancer by biomarkers before treatment begins. Determining whether a tumor is immunotherapy-sensitive is internationally recognized as one of the most important challenges within this condition. Based on a combination of existing laboratory techniques on tumor tissue and/or blood, the investigators seek to predict the likelihood of this treatment's success before initiating it. With this knowledge, the investigators could recommend alternative treatments to patients with tumors that are unresponsive. This way, they would also avoid exposure to the side effects of an ineffective therapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
* General inclusion Criteria:
1. Male or female, age \> 18 years
2. Diagnosis or suspected diagnosis of hepatocellular carcinoma based on imaging
* Specific inclusion criteria cohort 1 (retrospective/prospective data may be applicable):
1. Pathologically confirmed HCC
2. Treated with systemic treatment \[tyrosine kinase inhibitor (TKI) or immunotherapy (ICI)\] in the last 7 years and follow-up data (at least one imaging on treatment) available until 01/01/2025
3. Biopsy obtained between 01/01/2018 until 01/01/2025
4. Left-over tissue from previous diagnostic biopsies or resection specimens available
5. Time between biopsy and initiation of systemic treatment \< 1 year
6. Ability to sign informed consent for secondary use of archival tissue and data collection for study-specific research for patients who are alive
* Specific inclusion criteria cohort 2 (aHCC \& prospective):
1. Suspicion of hepatocellular carcinoma (imaging criteria or recurrent disease of previously treated HCC)
2. Indication for tumor biopsy per standard of care
3. Eligible for systemic treatment (any) after pathological confirmation of HCC
4. Ability to sign informed consent for primary use of tissue and blood samples and data collection for study-specific research
* Specific inclusion criteria cohort 3 (eHCC \& prospective):
1. Suspicion of hepatocellular carcinoma (imaging criteria or recurrent disease of previously treated HCC)
2. Indication for local treatment (resection or ablation)
3. Ability to sign informed consent for primary use of tissue and blood samples and for data collection for study-specific research
Due to the observational nature of this study, participation in other (interventional) clinical trials is permitted, if biological materials can be collected per protocol.
* General exclusion criteria:
1. Poor liver function and/or performance status which prohibits active treatment
2. Pathologically proven other malignancies of the liver, including primary cholangiocarcinoma or liver metastases
3. Treatment plan other than systemic treatment or local treatment (resection or ablation), such as TACE, TARE, liver transplantation
Primary outcome measure(s)
Spatial orientation — Through study completion, an average of 6 months Spatial orientation of cell types of interest in the tumour microenvironment (TME) of HCC using a variety of techniques: multiplex IHC, spatial proteomics and spatial transcriptomics. Samples from early (cohort 3) and advanced HCC (cohort 2) will be used.
TCR sharing — Through study completion, an average of 6 months Identification of shared TCR sequences between PBMCs and tumor tissue using RNA and TCR sequencing. Exploration of the degree of TCR sharing in early and advanced HCC.
Antigen identification — Through study completion, an average of 6 months The investigators will use tumor tissue and PBMC to construct an antigenic landscape of advanced HCC. To achieve this goal the investigators will use a unique technique called Transcriptome-Wide Screening for T cell Antigen Research (TWISTAR).
Biomarker validation — 12 months after tissue acquisition This study will be used to validate two candidate predictive biomarkers (CD45RA effector-memory CD8 T-cells/PDL1-expressing CXCL10+ macrophages) AND TCR sharing between tumor and blood in relation to response to immunotherapy in HCC.
The investigators will compare the biomarker positive and biomarker negative groups in terms of progression-free survival and overall survival (Kaplan-Meier time-to-event) in the context of known prognostic clinical variables (multivariable cox proportional hazards model).
Trial sites (4)
Facility
City
Region
Status
UZA
Antwerp
Belgium
Recruiting
Jessa ziekenhuis
Hasselt
Belgium
Recruiting
AZ Groeninge
Kortrijk
Belgium
Recruiting
AZ Delta
Roeselare
Belgium
Recruiting
More Universitaire Ziekenhuizen KU Leuven trials in Belgium
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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