Design considerations for clinical trials of radiotherapy combined with immunotherapy

Abstract

The discovery of synergistic effects between radiation and immunotherapy in pre-clinical studies has encouraged researchers to conduct clinical trials testing the effects of combined therapy in patients. The first step in conducting any clinical trial is to define the hypothesis and core objectives. The challenge while developing trials analyzing combinations of immunotherapy and radiation therapy (RT) is to select an appropriate hypothesis that can be tested in the future research, as well as raising new questions for investigation. Here, we review some of the concerns and challenges for designing clinical trials of RT combined with immunotherapy.