Immunotherapy and Carbon Ion Radiotherapy In Solid Cancers With Stable Disease
Status:
Not yet recruiting
Trial end date:
2026-08-01
Target enrollment:
Participant gender:
Summary
Immunotherapy has become the standard of care in different advanced malignancies. Its
effectiveness in the palliative setting was demonstrated by several phase III trials.
However, the response rate varies according to the cancer under study and to the line of
treatment. A potential way to improve the activity of single agent immune checkpoint
inhibitors (ICIs) is to enhance the clinical response through further antitumor agents,
including radiotherapy. Studies showed that carbon ions may lead to a broader immunogenic
response; for their dosimetric characteristics it is possible to reduce integral dose sparing
immune cells to direct and sustain a tumor specific immune response.
Considering the available preclinical and clinical evidence together, the goal of this study
is to explore the feasibility and the clinical activity of adding carbon ion radiotherapy
(CIRT), employed with a fractionation strategy comparable to stereotactic body radiation, to
ICIs in advanced malignancies where immunotherapy is currently the standard of care.
Phase:
Phase 2
Details
Lead Sponsor:
CNAO National Center of Oncological Hadrontherapy
Collaborators:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Fondazione IRCCS Policlinico San Matteo di Pavia