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RECRUITING

NCT07623265

Improving the Use of Immunotherapy to Treat Liver Cancer

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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.

Official title: Optimizing and Improving Immunotherapy for Hepatocellular Carcinoma: the IO-MARC Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-03-04

Completion Date

2032-01

Last Updated

2026-06-03

Healthy Volunteers

Conditions

Hepatocellular Carcinoma (HCC)

Interventions

OTHER

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.

* 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

Locations (4)

UZA

Antwerp, Belgium

Jessa ziekenhuis

Hasselt, Belgium

AZ Groeninge

Kortrijk, Belgium

AZ Delta

Roeselare, Belgium