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This phase II trial (NCT03936452) investigated the efficacy and safety of sintilimab, anlotinib, and pegaspargase sandwiched with radiotherapy as first\u2010line treatment in patients with newly\u2010diagnosed stage I\u2013II ENKTL. The patients received sintilimab 200\u2009mg plus pegaspargase 2500\u2009U\/m<jats:sup>2<\/jats:sup> on day 1 and anlotinib 12\u2009mg once daily on days 1\u201314 for three 21\u2010day\u2009cycles, followed by intensity\u2010modulated radiotherapy and another three cycles of systemic therapy. The primary endpoint was the complete response rate (CRR) after six treatment cycles. The secondary endpoints included progression\u2010free survival (PFS), overall survival (OS), CRR after two cycles, overall response rate (ORR) after six cycles, duration of response (DOR), and safety. Between May 2019 and July 2021, 58 patients were enrolled. The CRR was 55.1% (27\/49) after two cycles and 87.8% (43\/49) after six cycles. The ORR was 87.8% (43\/49; 95% CI, 75.2\u201395.4) after six cycles. After a median follow\u2010up of 22.5\u2009months (95% CI, 20.4\u201324.6), the median PFS, OS, and DOR were not reached. The 2\u2010year PFS, OS, and DOR rates were 87.6% (95% CI, 78.8\u201397.4), 97.9% (95% CI, 94.0\u2013100), and 91.1% (95% CI, 83.2\u201399.8), respectively. Grade 3\u20134 treatment\u2010related adverse events occurred in 41.4% (24\/58) of patients, with the most common being hypertension (15.5%), hypertriglyceridemia (8.6%), oral mucositis (6.9%), and anemia (5.2%). No treatment\u2010related deaths occurred. First\u2010line sintilimab, anlotinib, and pegaspargase sandwiched with radiotherapy demonstrated promising efficacy in treatment\u2010na\u00efve early\u2010stage ENKTL patients with a favorable safety profile.<\/jats:p>","DOI":"10.1002\/ajh.26922","type":"journal-article","created":{"date-parts":[[2023,3,27]],"date-time":"2023-03-27T08:50:26Z","timestamp":1679907026000},"page":"1043-1051","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["A phase <scp>II<\/scp> study of sintilimab, anlotinib, and pegaspargase sandwiched with radiotherapy as first\u2010line therapy in patients with newly diagnosed, stage <scp>I\u2013II<\/scp> extranodal natural\u2010killer\/T\u2010cell lymphoma"],"prefix":"10.1002","volume":"98","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3811-0371","authenticated-orcid":false,"given":"Peng","family":"Sun","sequence":"first","affiliation":[{"name":"Department of Medical Oncology Sun 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