Phase II Study Evaluating Radiation Therapy to Boost Immune Response in Adults With Metastatic Gastrointestinal Cancers Worsening on Immunotherapy

What this Trial Is About

Researchers are evaluating how well radiation therapy works for treating metastatic gastrointestinal cancers that are spreading to other parts of the body. The study aims to find out if radiation therapy can slow or stop cancer growth in patients whose cancers are progressing despite immunotherapy treatment. It also explores whether targeting one tumor with radiation can help the immune system attack other tumors not directly treated by radiation. Patients receive radiation therapy consisting of five treatments over 5 to 9 calendar days, unless their disease worsens or they experience unacceptable side effects. The radiation dose is planned and delivered following standard protocols, with up to five treatment sites. After completing radiation therapy, patients continue to be followed for up to 36 months to monitor their response and health. During the study, participants undergo regular evaluations including tumor response assessments using specific response criteria, safety monitoring of side effects, and measurements of immune system effects and tumor DNA in the blood. Follow-up visits are scheduled at 14 days, 6 months, and periodically up to 36 months. Researchers will assess overall response rate, progression, survival, local tumor control, new metastatic lesions, and time to new therapies as part of the study outcomes.

Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers