Abstract
This is a single-arm, phase II clinical trial aimed to evaluate mFOLFOX6 plus camrelizumab and apatinib as a neoadjuvant regimen for locally advanced colon cancer. This trial was registered on ClinicalTrials.gov (NCT04625803), with the registration date of November 30, 2020. The primary endpoint was the pathological response rate (TRG 2–4, Dworak criteria). Time-of-flight, imaging mass cytometry and spatial proteomic analysis was applied to explore efficacy-related predictive biomarkers. Of 12 enrolled patients, 11 underwent surgery. The TRG 2–4 rate was 81.8% overall (87.5% in the MSS subgroup). Five patients (45.5%) achieved pathological complete response (pCR). With a median follow-up of 36.60 months, only one patient relapsed. An increase in the frequency of CD8 + T-cells and a decreased frequency of tissue-resident memory 1 (Trm-1) and regulatory T (Treg) cells are associated with a favorable response to neoadjuvant therapy. Spatiotemporal multiomics analysis highlighted tissue-resident macrophages as potential predictive biomarkers and warrants further verification.
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Acknowledgements
We appreciate our gratitude to Prof. Jun Li for her valuable work in pathological analysis and to Prof. Bin Qi for his role in radiological tumor evaluation. This work was supported by the National Natural Science Foundation of China (82203186, 82373428), The “Pioneer” and “Leading Goose” R&D Program of Zhejiang (2025C02073), Noncommunicable Chronic Diseases-National Science and Technology Major Project (2023ZD0501600), and Beijing Xisike Clinical Oncology Research Foundation (Y-NESTLE2022QN-0345). The funder played no role in study design, data collection, analysis, and interpretation of data, or the writing of this manuscript.
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Zhou Tong, Weijia Fang-literature search, study design, writing; Xuanwen Bao, Liaoliao Gao- data analysis, data interpretation; Danyang Wang, Wenbin Chen - patients enrollment; Xiaomeng Dai, Hangyu Zhang, Lulu Liu -figures, data collection; Yang Gao, Xudong Zhu- patient management and treatment; Yi Zheng, Qihan Fu- data analyses; Peng Zhao, Fanlong Liu- study design, revised the manuscript; Xiangming Xu, Weijia Fang - study design, supervised the research.
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Tong, Z., Gao, L., Wang, D. et al. Neoadjuvant mFOLFOX6 plus camrelizumab and apatinib in colon cancer and biomarker research via spatiotemporal-omics profiling. npj Precis. Onc. (2026). https://doi.org/10.1038/s41698-026-01387-0
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DOI: https://doi.org/10.1038/s41698-026-01387-0
