Advanced Immune Gene and Cell Therapies for Liver Metastases in Colorectal and Pancreatic Cancer Observational Study Characterizing Tumor and Immune Microenvironment with Molecular and Immune Profiling

What this Trial Is About

Researchers are investigating liver metastases, which are the main cause of death in patients with colorectal carcinoma (CRC) and pancreatic ductal adenocarcinoma (PDAC). This observational study aims to better understand the tumor and immune environments in these cancers, focusing on identifying tumor-associated antigens, immune suppression pathways, and biological markers for early diagnosis and treatment response. The study also includes healthy volunteers as controls and integrates advanced molecular and immune profiling techniques to inform new advanced therapy medicinal products (ATMPs). The study involves collecting various biological samples such as peripheral blood, primary tumors, and liver metastases from patients with CRC and PDAC. Patients include those with metastatic CRC or PDAC, non-metastatic PDAC, and precancerous pancreatic lesions (IPMN). Samples are analyzed using multi-omics, spatial transcriptomics, flow cytometry, and machine learning to characterize immune and non-immune cells. Two substudies further explore immune interactions in liver CRC metastases and pancreatic lesions, supporting the development of novel immunotherapies. Participants will undergo sample collection during their standard clinical care and provide clinical data at enrollment and throughout follow-up (up to 2 years for PDAC patients and 3 years for CRC patients). The study monitors changes in tumor and immune profiles over time and correlates findings with clinical outcomes. Outcome measures include tumor mutational burden, immune landscape characterization, and identification of antigen-specific T cell receptors. The total study duration is 7 years, with ongoing biobanking for future research and validation of new therapies.

Advanced Therapies for Liver Metastases