Abstract
Clear cell renal cell carcinoma (ccRCC) remains a challenging malignancy to treat, with immune checkpoint inhibitors (ICIs) revolutionizing patient management. This pilot study, evaluated the efficacy and safety of combination therapy comprising camrelizumab, an anti-PD-1 antibody, and autologous cytokine-induced killer (CIK) cell therapy in patients with refractory ccRCC. Twenty-one patients with refractory ccRCC were randomly assigned to receive either camrelizumab monotherapy (control group, n = 12) or camrelizumab combined with CIK cell re-transfusion (trial group, n = 9). Due to early termination (21 of 60 planned patients), all endpoints were exploratory. The objective response rate (ORR) was numerically higher in the combination group (55.6% vs. 41.7%; odds ratio 1.75, 95% confidence interval [CI]: 0.32–9.51), but not statistically significant. Median progression-free survival (PFS) was 28.5 vs. 8.67 months (hazard ratio [HR] 0.40, 95% CI: 0.12–1.34), and median overall survival (OS) was not reached vs. 57.47 months (HR 0.48, 95% CI: 0.09–2.53). One patient in the trial group achieved a complete metabolic response (CMR). The combination was well-tolerated without new safety signals. Exploratory analysis suggested that higher baseline PD-1 expression on CD8+ T cells might be associated with a better response, and the frequency of PD-1 positive cells tended to decrease after camrelizumab administration. The addition of CIK cell therapy to anti-PD-1 antibody showed signals of potential benefit in refractory ccRCC with a tolerable safety profile. This pilot study suggests the combination approach appears feasible and warrants investigation in larger trials in pretreated ccRCC patients.
Registry: ClinicalTrials.gov, TRN: NCT03987698, Registration date: 17 June 2019.
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Acknowledgements
We are grateful to our coworkers for their contribution to the clinical management of the patients.
Funding
This work was funded by Tianjin Key Medical Discipline (Specialty) Construction Project (TJYXZDXK-009 A), The Science & Technology Development Fund of Tianjin Education Commission for Higher Education (2021KJ203), National Natural Science Foundation of China (82372779, 82373283, and 82302913), National Natural Science Foundation (NSFC) Cultivation Program of Tianjin Medical University Cancer Institute & Hospital (230103) and Doctor Startup Fund of Tianjin Medical University Cancer Institute and Hospital (B2414). This investigator-initiated trial funded by Tianjin Medical University Cancer Institute and Hospital. Drug supply: Camrelizumab was provided by Jiangsu Hengrui Medicine Co., Ltd. at no cost. Funder role: No involvement in study design, data collection, analysis, or manuscript preparation.
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S. Li and J. Qin wrote the main manuscript text. Q. Sun and H. Zhao conducted quality control and visualization. Y. Xiong, Y. Wang, Y. Han, J. Zhang, W. Zhang, M. Shen, F. Yang, B. Ren, and L. Zhou conducted data investigation and curation. R. Li, Z. Hui, X. Tian, S. Cao, and W. Du contributed to data interpretation. W. Yu performed flow cytometry assessments. L. Liu, X. Zhang, and X.Ren conceptualized the study, reviewed, and revised the whole manuscript. All authors agreed on all aspects of the work and approved the final version of the manuscript.
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Li, S., Qin, J., Sun, Q. et al. Randomized pilot study of camrelizumab with or without autologous cytokine-induced killer cells in refractory clear cell renal cell carcinoma. Sci Rep (2026). https://doi.org/10.1038/s41598-026-38881-1
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DOI: https://doi.org/10.1038/s41598-026-38881-1


