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World J Gastroenterol. Jul 14, 2026; 32(26): 117924
Published online Jul 14, 2026. doi: 10.3748/wjg.117924
Published online Jul 14, 2026. doi: 10.3748/wjg.117924
Radiotherapy-free neoadjuvant strategy using sintilimab plus XELOX in locally advanced rectal cancer: A single-arm phase II trial
Wei-Dong Qiang, Qi Wei, Bo Yang, Chang-Qing Lin, Yong-Xiang Li, Department of General Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, Anhui Province, China
Wan-Jing Chen, Department of General Surgery, The Second Affiliated Hospital of Anhui Medical University, Hefei 230022, Anhui Province, China
Co-first authors: Wei-Dong Qiang and Qi Wei.
Author contributions: Qiang WD and Wei Q contributed to study conception, clinical data collection, data analysis, manuscript drafting, and contributed equally as co-first authors; Yang B, Chen WJ, and Lin CQ participated in patient treatment, pathological review, and data interpretation; Li YX was responsible for the decision to submit the manuscript. All authors approved the final version of the manuscript.
Supported by National Natural Science Foundation of China, No. 82372646.
Institutional review board statement: This study was approved by the Ethics Committee of The First Affiliated Hospital of Anhui Medical University, No. PJ-2025-02-62.
Clinical trial registration statement: This study is registered in the Chinese Clinical Trial Registry (URL: https://www.chictr.org.cn), No. ChiCTR2500114358; and at ClinicalTrials.gov (URL: https://clinicaltrials.gov), No. NCT07127497.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The datasets generated and/or analyzed in the current study are available from the corresponding author upon reasonable request.
Corresponding author: Yong-Xiang Li, MD, PhD, Department of General Surgery, The First Affiliated Hospital of Anhui Medical University, No. 218 Jixi Road, Shushan District, Hefei 230022, Anhui Province, China. liyongxiang@ahmu.edu.cn
Received: December 22, 2025
Revised: January 30, 2026
Accepted: March 23, 2026
Published online: July 14, 2026
Processing time: 191 Days and 7 Hours
Revised: January 30, 2026
Accepted: March 23, 2026
Published online: July 14, 2026
Processing time: 191 Days and 7 Hours
Core Tip
Core Tip: This phase II single-arm study evaluated a radiotherapy-free neoadjuvant strategy using sintilimab plus XELOX in patients with locally advanced rectal cancer without mesorectal fascia involvement. The regimen achieved favorable pathological responses with acceptable toxicity. Tumor size > 4 cm and elevated baseline carcinoembryonic antigen levels were associated with a lower likelihood of major pathological response. Exploratory immune microenvironment analysis suggested a potential association between CD8+ T-cell infiltration and treatment response. These findings support further investigation of radiotherapy-sparing strategies in carefully selected patients.