Right patient approach to experimental stromal cell therapies for gastrointestinal tumors

Experimental therapies targeting immune and stromal cells, such as mast cells, cancer-associated fibroblasts, dendritic cells, and tumor endothelial cells, in the treatment of gastrointestinal solid tumors pose new and complex surgical and medico-legal challenges. These innovative treatments require that informed consent not be limited to simple acceptance of the medical procedure, but instead reflect a true relational and cognitive process grounded in understanding, free choice, and the ability to revoke consent at any time. In particular, it is essential that the patient understands the experimental nature of the therapy, its development stage, potential benefits and risks, as well as the implications for their health and personal dignity. In the case of stromal cell-based treatments, which may exert complex immunomodulatory effects or activate angiogenic pathways that are not yet fully understood, patients must be made fully aware that they are participating in a non-standardized therapy whose outcomes, whether beneficial or harmful, cannot yet be predicted with certainty. This requires particularly careful medical communication, using simple yet scientifically accurate explanations delivered in appropriate language, along with a final verification of the patient’s actual understanding.