{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T10:34:37Z","timestamp":1777890877183,"version":"3.51.4"},"reference-count":28,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T00:00:00Z","timestamp":1773878400000},"content-version":"vor","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T00:00:00Z","timestamp":1772323200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100013226","name":"Les Laboratories Pierre Fabre","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013226","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Colorectal cancer (CRC) is a major health burden globally and in China, where 3%\u20135% of cases involve the BRAF\n                      <jats:sup>V600E<\/jats:sup>\n                      mutation, which is associated with aggressive disease and therefore a poor prognosis. Although the combination of encorafenib and cetuximab has demonstrated improved survival in BRAF\n                      <jats:sup>V600E<\/jats:sup>\n                      mutant metastatic CRC (mCRC), such treatments remain unavailable as chemotherapy\u2010free options in China.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The NAUTICAL CRC, a Phase II study in Chinese patients with BRAF\n                      <jats:sup>V600E<\/jats:sup>\n                      mutant metastatic CRC, includes a Safety Lead\u2010In (SLI) phase for tolerability assessment and a randomized phase comparing encorafenib\/cetuximab vs. irinotecan\u2010based regimens, potentially bridging the treatment gap and evaluating safety, efficacy, and Quality of Life (QoL) outcomes in this Chinese population.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      No dose\u2010limiting toxicity was identified in the SLI phase (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200910). In the Randomized phase (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200997), the Doublet arm demonstrated superior progression\u2010free survival (PFS) of 4.2\u2009months vs. 2.5\u2009months in the Control arm (hazard ratio [HR]: 0.37,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0004) and longer overall survival (OS) of 11.6\u2009months vs. 8.2\u2009months (HR: 0.55). Treatment\u2010related adverse events were common but more severe in the Control arm. QoL measures consistently favored the Doublet arm, showing improved health status and reduced deterioration risk.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      This NAUTICAL CRC Phase II study showed that the combination of encorafenib and cetuximab offers significant clinical benefits, improving PFS and OS, while providing manageable safety and important QoL advantages, making it a valuable treatment option for Chinese patients with previously treated BRAF\n                      <jats:sup>V600E<\/jats:sup>\n                      mutant mCRC.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>Clinical study registration number: NCT05004350<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cam4.71697","type":"journal-article","created":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T08:37:30Z","timestamp":1773909450000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Randomized Trial of Encorafenib and Cetuximab Versus Irinotecan\/Cetuximab or\n                    <scp>FOLFIRI<\/scp>\n                    \/Cetuximab in Chinese Patients With\n                    <scp>\n                      BRAF\n                      <sup>V600E<\/sup>\n                    <\/scp>\n                    Mutant Metastatic Colorectal Cancer: The\n                    <scp>NAUTICAL<\/scp>\n                    Study"],"prefix":"10.1002","volume":"15","author":[{"given":"Wang","family":"Xicheng","sequence":"first","affiliation":[{"name":"Peking University Cancer Hospital and Institute  Beijing 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