{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T11:13:08Z","timestamp":1780053188015,"version":"3.54.0"},"reference-count":21,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T00:00:00Z","timestamp":1780012800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Pancreatic cancer remains one of the most lethal malignancies, with a five-year survival rate of merely 8% for exocrine tumors, and conventional chemotherapy offering limited clinical benefit. Nab-paclitaxel plus gemcitabine (AG) is a standard first-line regimen, yet outcomes remain suboptimal. Nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody with a favorable tolerability profile, has demonstrated promising activity in combination with gemcitabine in KRAS wild-type pancreatic cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study aimed to preliminarily evaluate the efficacy and safety of nimotuzumab combined with gemcitabine and nab-paclitaxel (NTZ-AG) as first-line therapy in patients with locally advanced or metastatic pancreatic cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This single-arm, single-center Phase II prospective study enrolled 16 patients (aged 18\u201375\u202fyears, ECOG PS 0\u20131) with pathologically confirmed Stage III\u2013IV pancreatic cancer without prior systemic chemotherapy. Patients received nimotuzumab 400\u202fmg (day 1, 3-h infusion), gemcitabine 1,000\u202fmg\/m\n                      <jats:sup>2<\/jats:sup>\n                      (days 1 and 8), and nab-paclitaxel 125\u202fmg\/m\n                      <jats:sup>2<\/jats:sup>\n                      (days 1 and 8) every 21\u202fdays for up to 6\u202fcycles. The primary endpoint was objective response rate (ORR), assessed per RECIST v1.1; secondary endpoints included progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR), duration of response (DOR), and safety, graded per NCI-CTCAE v5.0.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 16 evaluable patients, the ORR was 68.75% (11\/16; 95% CI: 42.81\u201387.34%), with no complete responses and 11 partial responses. The disease control rate (DCR) was 100%. Median PFS was 6.0\u202fmonths (95% CI: 4.06\u20137.95) and median OS was 12.0\u202fmonths (95% CI: 8.35\u201315.66), with one patient achieving an OS of 49\u202fmonths. Adverse events were predominantly Grade 1\u20132; no Grade 4 or higher toxicities were observed. Grade 3 events included alopecia (81.2%), nausea (12.5%), and myelosuppression.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The NTZ-AG regimen demonstrated meaningful anti-tumor activity and an acceptable safety profile as first-line therapy for unselected advanced pancreatic cancer patients, providing a rational basis for larger randomized controlled trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>\n                      This trial was registered at the Chinese Clinical Trial Register (ChiCTR) under the registration number ChiCTR2300072843 having URL\n                      <jats:ext-link>https:\/\/www.chictr.org.cn\/showprojEN.html?proj=198791<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fmed.2026.1838482","type":"journal-article","created":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T10:41:10Z","timestamp":1780051270000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Nimotuzumab combined with gemcitabine and nab-paclitaxel as first-line therapy for advanced pancreatic cancer: a single-arm, single-center Phase II prospective study"],"prefix":"10.3389","volume":"13","author":[{"given":"Lin","family":"Lin","sequence":"first","affiliation":[{"name":"Department of Oncology, The First Affiliated Hospital of Shenzhen University, The Second People\u2019s Hospital of Shenzhen","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinyi","family":"Zhao","sequence":"additional","affiliation":[{"name":"Shenzhen University","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yawen","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Oncology, The First Affiliated Hospital of Shenzhen University, The Second People\u2019s Hospital of Shenzhen","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia-Hua","family":"Cai","sequence":"additional","affiliation":[{"name":"School of Public Health, Southern Medical University","place":["Guangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhihuan","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Oncology, The First Affiliated Hospital of Shenzhen University, The Second People\u2019s Hospital of Shenzhen","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liang","family":"Xiao","sequence":"additional","affiliation":[{"name":"Department of Oncology, The First Affiliated Hospital of Shenzhen University, The Second People\u2019s Hospital of Shenzhen","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geng","family":"Tian","sequence":"additional","affiliation":[{"name":"Department of Oncology, The First Affiliated Hospital of Shenzhen University, The Second People\u2019s Hospital of Shenzhen","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaozhong","family":"He","sequence":"additional","affiliation":[{"name":"Department of Oncology, Sanya Central Hospital (Hainan Third People\u2019s Hospital)","place":["Sanya, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,5,29]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"e530","DOI":"10.1097\/MPA.0000000000002489","article-title":"Factors driving pancreatic cancer survival 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