Abstract
Standard neoadjuvant chemoradiotherapy for locally advanced rectal cancer (LARC) is associated with significant toxicity and limited pathological responses. We retrospectively compared a radiotherapy‑free regimen of camrelizumab plus modified FOLFOXIRI versus modified FOLFOXIRI alone in consecutive patients with clinical stage II–III LARC treated from 2022–2025 (n = 146). All patients received ≥3 cycles of neoadjuvant therapy; surgery or watch‑and‑wait was determined by a multidisciplinary team. Baseline characteristics were well balanced. Among surgical patients, pCR rates were 29.8% with camrelizumab plus FOLFOXIRI and 19.6% with FOLFOXIRI alone. Radiologic objective response rates were 70.7% and 53.5%, respectively, and mean neoadjuvant rectal scores were lower with camrelizumab (13.95 vs 23.77; P < 0.02). Disease‑free survival was significantly improved in the camrelizumab group, while overall survival was similar at current follow‑up. Grade 3–4 hematologic and gastrointestinal toxicities were comparable, and no unexpected immune‑related events occurred. Camrelizumab plus FOLFOXIRI appears to be an active, tolerable radiotherapy‑free neoadjuvant option for LARC.
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The datasets generated and/or analysed during the current study are not publicly available due to institutional policy and patient privacy restrictions, but are available from the corresponding author on reasonable request and subject to approval by the institutional ethics committee.
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Acknowledgements
This research was funded by the Nn10 Cultivation Project of the Affiliated Cancer Hospital of Harbin Medical University and the Heilongjiang Provincial Natural Science Foundation (Project No. PL2024H173). The authors thank the patients and their families, and the multidisciplinary team at Harbin Medical University Cancer Hospital for their contributions to this study.
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Binbin Cui and Yanlong Liu conceived and designed the study. Shihui Zhao, Songtao Du, Liqiang Song, and Tianyi Xia enrolled patients and acquired clinical data. Fenqi Du performed the data analysis and contributed to data interpretation. Yanlong Liu and Shihui Zhao interpreted the results and drafted the manuscript. Bomiao Zhang provided administrative and logistical support. Binbin Cui supervised the study. All authors critically revised the manuscript, approved the final version, and agree to be accountable for all aspects of the work.
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Liu, Y., Zhao, S., Du, F. et al. Neoadjuvant FOLFOXIRI chemotherapy with or without camrelizumab in the treatment of locally advanced rectal cancer: a retrospective cohort study. npj Precis. Onc. (2026). https://doi.org/10.1038/s41698-026-01401-5
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DOI: https://doi.org/10.1038/s41698-026-01401-5
