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Here, we reported a Simon\u2019s minmax two-stage, single-arm, phase 2 clinical trial (NCT03208413) to assess the efficacy of thalidomide in patients with RIBI who were unresponsive to or had contraindications to bevacizumab and corticosteroid therapies. The trial met its primary endpoint, with 27 of 58 patients enrolled showing \u226525% reduction in the volume of cerebral edema on fluid-attenuated inversion recovery\u2013magnetic resonance imaging (FLAIR-MRI) after treatment (overall response rate, 46.6%; 95% CI, 33.3 to 60.1%). Twenty-five (43.1%) patients demonstrated a clinical improvement based on the Late Effects Normal Tissues\u2013Subjective, Objective, Management, Analytic (LENT\/SOMA) scale, and 36 (62.1%) experienced cognitive improvement based on the Montreal Cognitive Assessment (MoCA) scores. In a mouse model of RIBI, thalidomide restored the blood-brain barrier and cerebral perfusion, which were attributed to the functional rescue of pericytes secondary to elevation of platelet-derived growth factor receptor \u03b2 (PDGFR\u03b2) expression by thalidomide. Our data thus demonstrate the therapeutic potential of thalidomide for the treatment of radiation-induced cerebral vasculature impairment.<\/jats:p>","DOI":"10.1126\/scitranslmed.abm6543","type":"journal-article","created":{"date-parts":[[2023,2,22]],"date-time":"2023-02-22T18:58:47Z","timestamp":1677092327000},"update-policy":"https:\/\/doi.org\/10.34133\/aaas_crossmark","source":"Crossref","is-referenced-by-count":50,"title":["A phase 2 study of thalidomide for the treatment of radiation-induced blood-brain barrier injury"],"prefix":"10.1126","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0560-6381","authenticated-orcid":true,"given":"Jinping","family":"Cheng","sequence":"first","affiliation":[{"name":"Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, China."},{"name":"Brain Research Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, 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