{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T00:24:59Z","timestamp":1772497499759,"version":"3.50.1"},"reference-count":27,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,4,14]],"date-time":"2025-04-14T00:00:00Z","timestamp":1744588800000},"content-version":"vor","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Thoracic Cancer"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The current standard treatment for advanced and metastatic esophageal squamous cell carcinoma (ESCC) involves a combination of immunotherapy and chemotherapy, but paclitaxel's hormone preconditioning can reduce immune response and effectiveness. Polymeric micellar paclitaxel (Pm\u2010Pac), a nanoformulation, bypasses this issue, enhancing tumor permeability and retention. While Pm\u2010Pac has shown promise in non\u2010small cell lung cancer, its efficacy in ESCC is yet to be established.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This is a prospective phase II trial involving untreated stage IV ESCC receiving two cycles of Pm\u2010Pac, cisplatin, and tislelizumab. If no disease progression was observed, they received two additional cycles followed by a year of tislelizumab maintenance. Each 3\u2010week\u2009cycle consisted of Pm\u2010Pac (230\u2009mg\/m<jats:sup>2<\/jats:sup>), cisplatin (70\u2009mg\/m<jats:sup>2<\/jats:sup>), and tislelizumab (200\u2009mg) on Day 1. The main objective was ORR. Secondary endpoints encompassed OS, PFS, DCR, and safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between September 1, 2022, and June 30, 2024, 23 patients were included in the study. The median follow\u2010up period was 14.8\u2009months. The ORR stood at 69.6% (95% CI: 0.45\u20130.84) with a DCR of 100% (95% CI: 0.86\u20131.00). Out of the patients, 2 experienced complete responses, 14 had partial responses, and 7 maintained stable diseases. The mPFS was 10.8\u2009months (95% CI: 0.26\u20130.632). The 1\u2010year OS rate was 69.6% (95% CI: 49.1\u201384.4). Notably, no grade 3 or higher treatment\u2010related adverse events or treatment\u2010linked fatalities were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The combination of Pm\u2010Pac, cisplatin, and tislelizumab as an initial therapy for advanced ESCC is safe and effective and should be tested on a larger scale in the future.<\/jats:p><jats:p><jats:bold>Trial Registration:<\/jats:bold> Chinese Clinical Trial Registry: ChiCTR2400088576<\/jats:p><\/jats:sec>","DOI":"10.1111\/1759-7714.70055","type":"journal-article","created":{"date-parts":[[2025,4,14]],"date-time":"2025-04-14T22:57:31Z","timestamp":1744671451000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Polymeric Micellar Paclitaxel Plus Cisplatin Combined With Tislelizumab as the First\u2010Line Treatment of Advanced Unresectable Esophageal Squamous Cell Carcinoma: A Phase <scp>II<\/scp> Study"],"prefix":"10.1111","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0307-3534","authenticated-orcid":false,"given":"Xiaoyou","family":"Li","sequence":"first","affiliation":[{"name":"Department of Medical Oncology Jiangsu Cancer Hospital &amp; Jiangsu Institute of Cancer Research &amp; The Affiliated Cancer Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiamin","family":"Shi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Jiangsu Cancer Hospital &amp; Jiangsu Institute of Cancer Research &amp; The Affiliated Cancer Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinghua","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Jiangsu Cancer Hospital &amp; Jiangsu Institute of Cancer Research &amp; The Affiliated Cancer Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jingni","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Jiangsu Cancer Hospital &amp; Jiangsu Institute of Cancer Research &amp; The Affiliated Cancer Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fei","family":"Yan","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Jiangsu Cancer Hospital &amp; Jiangsu Institute of Cancer Research &amp; The Affiliated Cancer Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Delin","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Jiangsu Cancer Hospital &amp; Jiangsu Institute of Cancer Research &amp; The Affiliated Cancer Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guochun","family":"Cao","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Jiangsu Cancer Hospital &amp; Jiangsu Institute of Cancer Research &amp; The Affiliated Cancer Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,4,14]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21660"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.thorsurg.2022.08.001"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1159\/000510446"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdl104"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.apsb.2021.05.003"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biomaterials.2021.121061"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.7150\/thno.57828"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.actbio.2020.12.009"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijpharm.2022.121961"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2020.10.479"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12943-021-01489-2"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.21.02508"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.15584"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2019.02022"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/BS9.0000000000000149"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00262-018-2160-x"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1136\/jitc\u20102019\u2010000437"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1080\/17512433.2023.2274544"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrc1317"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1091\/mbc.e14-04-0916"},{"issue":"17","key":"e_1_2_10_22_1","first-page":"3752","article-title":"Vascular Permeability in a Human Tumor Xenograft: Molecular Size Dependence and Cutoff Size","volume":"55","author":"Yuan F.","year":"1995","journal-title":"Cancer Research"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10637-017-0506-4"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41392-020-00323-3"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10147-018-1239-x"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1998.16.5.1826"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2111380"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.21.01926"}],"container-title":["Thoracic Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1759-7714.70055","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,15]],"date-time":"2025-04-15T03:08:20Z","timestamp":1744686500000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1759-7714.70055"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4]]},"references-count":27,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["10.1111\/1759-7714.70055"],"URL":"https:\/\/doi.org\/10.1111\/1759-7714.70055","archive":["Portico"],"relation":{},"ISSN":["1759-7706","1759-7714"],"issn-type":[{"value":"1759-7706","type":"print"},{"value":"1759-7714","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4]]},"assertion":[{"value":"2024-11-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-19","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-14","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70055"}}