{ "abstract": "Patients with esophageal squamous cell carcinoma (ESCC) have an unmet need for new therapies that improve survival. In this phase II trial, patients received ociperlimab and tislelizumab (A) or placebo and tislelizumab (B) (NCT04732494). The primary endpoint was objective response rate (ORR) assessed by the investigator per RECIST v1.1. A total of 125 patients were randomized to A (N = 62) and B (N = 63). The primary endpoint was not met, with an ORR (95% confidence interval [CI]) assessed by the investigator of 30.6% (19.6-43.7) for A and 20.6% (11.5-32.7) for B (stratified risk difference: 9.9% [95% CI - 5.4 to 25.3]; stratified 2-sided p = 0.2114). At the final analysis, median OS (95% CI) was 10.2 (7.9-19.5) months for A and 9.3 (6.4-14.8) months for B (stratified HR [95% CI]: 0.92 [0.58-1.45]). A total of 25.8% (16/62) and 20.6% (13/63) of patients in A and B, respectively, experienced grade ≥3 treatment-related treatment-emergent adverse events. Exploratory biomarker analyses showed that patients with an inflamed tumor microenvironment, shown by the enriched expression of natural killer (NK) cells, T cells, macrophages, dendritic cells, and B-cell signatures, and NK cell signature enrichment, may benefit from ociperlimab plus tislelizumab. Adding ociperlimab to tislelizumab did not provide significant efficacy improvement in recurrent/metastatic second-line ESCC; the addition of ociperlimab to tislelizumab was generally well-tolerated. Trial registration: Clinicaltrials.gov: NCT04732494.", "abstract_shown": true, "affiliations": [ "Department of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-Sen University Cancer Center, Guangzhou, China.", "China Medical University Hospital, Taichung, Taiwan, ROC.", "School of Pharmacy, China Medical University, Taichung, Taiwan, ROC.", "Samsung Medical Center, Seoul, South Korea.", "Chiayi Chang Gung Memorial Hospital, Puzi City, Taiwan, ROC.", "Sichuan Provincial People's Hospital, Chengdu, China.", "The Second Hospital of Anhui Medical University, Hefei, China.", "The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, South Korea.", "Anhui Provincial Hospital, Hefei, China.", "Liaoning Cancer Hospital & Institute, Shenyang, China.", "People's Hospital of Deyang City, Deyang, China.", "CHU de Poitiers, Poitiers, France.", "Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.", "University Hospitals Gasthuisberg/Leuven and University of Leuven, Leuven, Belgium.", "Department of Gastroenterology and Digestive Oncology, Hôpital Européen Georges Pompidou, Paris-Cité University, Paris, France.", "Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.", "Medical Oncology Unit, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.", "BeOne Medicines, Ltd, Shanghai, China.", "Department of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-Sen University Cancer Center, Guangzhou, China. xurh@sysucc.org.cn." ], "article_type": "research support, non u.s. gov't", "arxiv": null, "author_total": 22, "authors": [ { "affs": [ 0 ], "name": "Feng Wang", "orcid": "0000-0001-7668-9674" }, { "affs": [ 1, 2 ], "name": "Chen-Yuan Lin" }, { "affs": [ 3 ], "name": "Jong-Mu Sun" }, { "affs": [ 4 ], "name": "Chang-Hsien Lu" }, { "affs": [ 5 ], "name": "Xueqiang Zhu" }, { "affs": [ 6 ], "name": "Zhendong Chen" }, { "affs": [ 0 ], "name": "Qi Zhao", "orcid": "0000-0002-8683-6145" }, { "affs": [ 7 ], "name": "In-Ho Kim" }, { "affs": [ 8 ], "name": "Yueyin Pan" }, { "affs": [ 9 ], "name": "Jingdong Zhang" }, { "affs": [ 10 ], "name": "Zhaohong Chen" }, { "affs": [ 11 ], "name": "David Tougeron", "orcid": "0000-0002-8065-9635" }, { "affs": [ 12 ], "name": "Sung-Bae Kim" }, { "affs": [ 13 ], "name": "Eric Van Cutsem" }, { "affs": [ 14 ], "name": "Aziz Zaanan", "orcid": "0000-0001-8372-5653" }, { "affs": [ 15 ], "name": "Fernando Rivera" }, { "affs": [ 16 ], "name": "Arunee Dechaphunkul" }, { "affs": [ 17 ], "name": "Yunxia Zuo" }, { "affs": [ 17 ], "name": "Qiting Wan" }, { "affs": [ 17 ], "name": "Juan Zhang" }, { "affs": [ 17 ], "name": "Jiadong Zhou" }, { "affs": [ 18 ], "name": "Rui-Hua Xu", "orcid": "0000-0001-9771-8534" } ], "bibtex": "https://research.draconitic.com/paper/39qfrqejjytt2.bib", "cited_by": 0, "doi": "10.1038/s41467-026-77705-8", "fulltext_url": "https://europepmc.org/articles/PMC13683355", "id": "39qfrqejjytt2", "issns": [ "2041-1723" ], "landing_url": "https://europepmc.org/article/MED/42901884", "language": "eng", "licence": "CC-BY-NC-ND", "licence_label": "CC BY-NC-ND", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/", "metadata_licence": null, "native_subjects": [ [ "openalex", "2746|Esophageal Cancer Research and Treatment" ] ], "openalex": "W7213537735", "pdf_url": "https://europepmc.org/articles/PMC13683355?pdf=render", "pmcid": "PMC13683355", "pmid": "42901884", "published": "2026-09-18", "publisher": null, "ris": "https://research.draconitic.com/paper/39qfrqejjytt2.ris", "sources": [ { "first_seen": "2026-10-30T12:19:41Z", "native_id": "MED:42901884", "source": "europepmc", "url": "https://europepmc.org/article/MED/42901884" } ], "subjects": [ { "field": "medicine", "origin": "openalex:2746|Esophageal Cancer Research and Treatment", "subfield": "surgery" } ], "title": "Ociperlimab and tislelizumab in advanced esophageal squamous cell carcinoma (AdvanTIG-203): a phase II study.", "title_text": "Ociperlimab and tislelizumab in advanced esophageal squamous cell carcinoma (AdvanTIG-203): a phase II study.", "type": "peer-reviewed", "updated_at": "2026-10-30T12:19:41Z", "url": "https://research.draconitic.com/paper/39qfrqejjytt2", "venue": "Nature communications", "versions": [] }