{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,28]],"date-time":"2026-02-28T04:51:25Z","timestamp":1772254285018,"version":"3.50.1"},"reference-count":53,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2025,6,21]],"date-time":"2025-06-21T00:00:00Z","timestamp":1750464000000},"content-version":"vor","delay-in-days":20,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Bayer Healthcare SAS","award":["001759\/0"],"award-info":[{"award-number":["001759\/0"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,6,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>New therapeutic options are needed for biliary tract cancer (BTC). Regorafenib, a multikinase inhibitor, shows promise in refractory digestive cancers and may be beneficial with conventional chemotherapy for BTC.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Patients and Methods<\/jats:title>\n                  <jats:p>The BREGO study evaluated regorafenib with modified gemcitabine-oxaliplatin (mGEMOX) in advanced or metastatic BTC. Phase I determined the recommended dose (RP2D) of regorafenib (80, 120 or 160\u00a0mg, days 1-14) combined with mGEMOX (gemcitabine 900\u00a0mg.m\u22122 IV, 30\u00a0min, followed by oxaliplatin 80mg.m\u22122 IV, 120\u00a0min, days 1 and 8). Phase II randomized (1:2) patients to mGEMOX alone (arm A) or mGEMOX\u2005+\u2005regorafenib (arm B, RP2D, days 1-14), assessing efficacy and safety, with the primary outcome being progression-free survival (PFS). Metabolic tumor features and response were also assessed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In phase Ib, 22 patients were enrolled; in phase II, 66 patients (arm A, n\u2005=\u200524; arm B, n\u2005=\u200542). Four dose-limiting toxicities were observed, but no maximum tolerated dose was reached. The RP2D was 160\u00a0mg.d\u22121. Median PFS (7.2 vs7.8 months; P\u2005=\u2005.825) and overall survival (15.1 vs 13.5 months; P\u2005=\u2005.356) were similar between arms. However, posttreatment 18F-FDG tumor uptake (SULpeak) significantly correlated with PFS (P\u2005=\u2005.001) and OS (P\u2005=\u2005.016). Baseline plasma stanniocalcin 1 levels\u2005&amp;lt;\u2005265 pg.mL\u22121 were associated with longer PFS (P\u2005=\u2005.030) and OS (P\u2005=\u2005.060) in both arms.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Combining regorafenib and mGEMOX is feasible as first-line treatment for BTC but did not increase PFS as expected in the phase II cohort. Identifying new biomarkers can help target patients with advanced BTCs who may benefit from regorafenib-associated therapy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>ClinicalTrials.gov, NCT02386397.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyaf080","type":"journal-article","created":{"date-parts":[[2025,6,28]],"date-time":"2025-06-28T02:06:52Z","timestamp":1751076412000},"source":"Crossref","is-referenced-by-count":2,"title":["Regorafenib plus modified gemcitabine-oxaliplatin in patients with advanced biliary tract cancer. The randomized phase Ib\/II BREGO study"],"prefix":"10.1093","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6172-9485","authenticated-orcid":false,"given":"Jean-Fr\u00e9d\u00e9ric","family":"Blanc","sequence":"first","affiliation":[{"name":"Department of Hepato-Gastroenterology and Medical Oncology, University of Bordeaux Hospital, Haut Leveque Hospital , 33600 Pessac ,","place":["France"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3919-4135","authenticated-orcid":false,"given":"Mohamed","family":"Bouattour","sequence":"additional","affiliation":[{"name":"AP-HP, Liver Cancer and Innovative Therapy, Beaujon Hospital , 92110 Clichy ,","place":["France"]},{"name":"Inserm U1149, Inflammation Research Center (CRI), Paris Cit\u00e9 University , 75018 Paris 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Montpellier Cancer Institute (ICM), Montpellier University , 34298 Montpellier Cedex 5 ,","place":["France"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christophe","family":"Borg","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, CHU Besan\u00e7on , 25030 Besan\u00e7on ,","place":["France"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-5593-8711","authenticated-orcid":false,"given":"Lobna","family":"Harguem","sequence":"additional","affiliation":[{"name":"Department of Clinical Research and Innovation,\u00a0Montpellier Cancer Institute (ICM), Montpellier University , 34298 Montpellier Cedex 5 ,","place":["France"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8344-1762","authenticated-orcid":false,"given":"Rosine","family":"Guimbaud","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, CHU Toulouse , 31400 Toulouse ,","place":["France"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laurent","family":"Mineur","sequence":"additional","affiliation":[{"name":"Gastrointestinal and Liver Oncology Unit, St Catherine Institute of Cancer Avignon-Provence , 84918 Avignon Cedex 01 ,","place":["France"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7378-9469","authenticated-orcid":false,"given":"Marc","family":"Ychou","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Montpellier Cancer Institute (ICM), Montpellier University , 34298 Montpellier Cedex 5 ,","place":["France"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5644-9603","authenticated-orcid":false,"given":"Thibault","family":"Mazard","sequence":"additional","affiliation":[{"name":"Inserm U1194, Montpellier Cancer Research Institute (IRCM), Montpellier University , 34298 Montpellier Cedex 5 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