{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T19:55:08Z","timestamp":1793994908176,"version":"4.8.0"},"reference-count":58,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T00:00:00Z","timestamp":1769212800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Beijing Hope Run Special Fund of Cancer Foundation of China","award":["LC2022A03"],"award-info":[{"award-number":["LC2022A03"]}],"id":[{"id":"https:\/\/ror.org\/03qendm16","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Wu Jieping Medical Foundation","award":["320.6750.2022-16-15"],"award-info":[{"award-number":["320.6750.2022-16-15"]}],"id":[{"id":"https:\/\/ror.org\/05dgwj702","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Major Project of Medical Oncology Key Foundation of Cancer Hospital Chinese Academy of Medical Sciences","award":["CICAMS-MOMP 2022010"],"award-info":[{"award-number":["CICAMS-MOMP 2022010"]}]},{"name":"National Science and Technology Major Project for Key New Drug Development","award":["2017ZX09304015"],"award-info":[{"award-number":["2017ZX09304015"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Thyroid\u00ae"],"published-print":{"date-parts":[[2026,3,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>\n                      Anaplastic thyroid carcinoma (ATC) is a rare and highly aggressive malignancy. Dabrafenib plus trametinib has shown efficacy in\n                      <jats:italic toggle=\"yes\">\n                        BRAF\n                        <jats:sup>V600E<\/jats:sup>\n                      <\/jats:italic>\n                      -mutant ATC, but effective therapies remain limited for patients without this mutation. This study aimed to evaluate the efficacy and safety of anlotinib plus sintilimab in\n                      <jats:italic toggle=\"yes\">\n                        BRAF\n                        <jats:sup>V600E<\/jats:sup>\n                      <\/jats:italic>\n                      -negative ATC.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      In this phase 2 trial, patients with\n                      <jats:italic toggle=\"yes\">\n                        BRAF\n                        <jats:sup>V600E<\/jats:sup>\n                      <\/jats:italic>\n                      -negative unresectable or metastatic ATC received anlotinib (12 mg orally once daily on days 1\u201314 of a 21-day cycle) plus sintilimab (200 mg intravenously on day 1). The primary endpoint was investigator-assessed objective response rate (ORR). This study is registered at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.chictr.org.cn\/\">www.chictr.org.cn<\/jats:ext-link>\n                      , ChiCTR2200067045.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      From December 27, 2022, to June 11, 2025, 21 patients were enrolled. One (4.8%) patient achieved complete response, and nine (42.9%) patients achieved partial response. The ORR and disease control rate were 47.6% (10\/21) and 85.7% (18\/21), respectively. After median follow-up of 9.97 months (confidence interval [CI] 6.10 to NA), 61.9% (13\/21) of patients had discontinued treatment, mainly due to disease progression (7\/21, 33.3%), adverse events (AEs) (2\/21, 9.5%), and other reasons (4\/21, 19.0%). Median progression-free survival (PFS) was 9.63 months (CI 4.03 to NA), with eight (38.1%) patients were still on treatment. Subgroup analysis showed longer PFS in patients with neutrophil\u2013lymphocyte ratio &lt;3.06 (18.43 vs. 3.67 months;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      = 0.010) and &lt;5 (14.23 vs. 2.67 months;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      = 0.002). Median overall survival was not reached (CI 13.90 to NA), 15 (71.4%) patients remained alive. AEs occurred in 66.7% (14\/21) of patients, including grade 3 AEs in 19.0% (4\/21). The most common were aspartate aminotransferase (AST) increased (6\/21, 28.6%) and alanine aminotransferase (ALT) increased (5\/21, 23.8%). Grade 3 immune-related AEs occurred in three patients, including AST\/ALT increased, diarrhea, hypertension, and hypertriglyceridemia.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>\n                      Anlotinib plus sintilimab showed favorable efficacy and manageable safety in\n                      <jats:italic toggle=\"yes\">\n                        BRAF\n                        <jats:sup>V600E<\/jats:sup>\n                      <\/jats:italic>\n                      -negative unresectable or metastatic ATC, supporting further investigation.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10507256261416838","type":"journal-article","created":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T15:13:36Z","timestamp":1769267616000},"page":"268-277","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Anlotinib Plus Sintilimab for\n                    <i>\n                      BRAF\n                      <sup>V600E<\/sup>\n                    <\/i>\n                    Negative Unresectable or Metastatic Anaplastic Thyroid Carcinoma: A Single-Center, Single-Arm, Phase 2 Trial"],"prefix":"10.1177","volume":"36","author":[{"given":"Lin","family":"Gui","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Beijing Key Laboratory of Key Technologies for Early Clinical Trial Evaluation of Innovative Drugs for Major Diseases, National Cancer Center\/National Clinical Research Center for Cancer\/Cancer Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College, Beijing, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haohua","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Beijing Key Laboratory of Key Technologies for Early Clinical Trial Evaluation of Innovative Drugs for Major Diseases, National Cancer Center\/National Clinical Research Center for Cancer\/Cancer Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College, Beijing, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Le","family":"Tang","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Beijing Key Laboratory of Key Technologies for Early Clinical Trial Evaluation of Innovative Drugs for Major Diseases, National Cancer Center\/National Clinical Research Center for Cancer\/Cancer Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College, Beijing, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yiming","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgical Oncology, National Cancer Center\/National Clinical Research Center for Cancer\/Cancer Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College, Beijing, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ye","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, National Cancer Center\/National Clinical Research Center for Cancer\/Cancer Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College, Beijing, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haizhen","family":"Lu","sequence":"additional","affiliation":[{"name":"Department of Pathology, National Cancer Center\/National Clinical Research Center for Cancer\/Cancer Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College, Beijing, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weihua","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pathology, National Cancer Center\/National Clinical Research Center for Cancer\/Cancer Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College, Beijing, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiarui","family":"Yao","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Beijing Key Laboratory of Key Technologies for Early Clinical Trial Evaluation of Innovative Drugs for Major Diseases, National Cancer Center\/National Clinical Research Center for Cancer\/Cancer Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College, Beijing, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Song","family":"Ni","sequence":"additional","affiliation":[{"name":"Department of Head and 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