RecruitingNot ApplicableNCT07623265

Improving the Use of Immunotherapy to Treat Liver Cancer

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

300 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma (HCC)

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

Min Age: 18 Years

Inclusion Criteria16

Male or female, age > 18 years
Diagnosis or suspected diagnosis of hepatocellular carcinoma based on imaging
Pathologically confirmed HCC
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
Biopsy obtained between 01/01/2018 until 01/01/2025
Left-over tissue from previous diagnostic biopsies or resection specimens available
Time between biopsy and initiation of systemic treatment < 1 year
Ability to sign informed consent for secondary use of archival tissue and data collection for study-specific research for patients who are alive
Suspicion of hepatocellular carcinoma (imaging criteria or recurrent disease of previously treated HCC)
Indication for tumor biopsy per standard of care
Eligible for systemic treatment (any) after pathological confirmation of HCC
Ability to sign informed consent for primary use of tissue and blood samples and data collection for study-specific research
Suspicion of hepatocellular carcinoma (imaging criteria or recurrent disease of previously treated HCC)
Indication for local treatment (resection or ablation)
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.

Exclusion Criteria3

Poor liver function and/or performance status which prohibits active treatment
Pathologically proven other malignancies of the liver, including primary cholangiocarcinoma or liver metastases
Treatment plan other than systemic treatment or local treatment (resection or ablation), such as TACE, TARE, liver transplantation

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Interventions

OTHERBlood 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.