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Randomized pilot study of camrelizumab with or without autologous cytokine-induced killer cells in refractory clear cell renal cell carcinoma
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  • Published: 07 February 2026

Randomized pilot study of camrelizumab with or without autologous cytokine-induced killer cells in refractory clear cell renal cell carcinoma

  • Shuzhan Li1,2,3,4,
  • Jing Qin1,2,3,5,
  • Qian Sun1,2,3,5,
  • Hua Zhao1,2,3,5,
  • Yanjuan Xiong1,2,3,4,
  • Yang Wang1,2,3,4,
  • Ying Han1,2,3,4,
  • Jiali Zhang1,2,3,4,
  • Weihong Zhang1,2,3,4,
  • Meng Shen1,2,3,4,
  • Fan Yang1,2,3,4,
  • Baozhu Ren1,2,3,4,
  • Li Zhou1,2,3,4,
  • Runmei Li1,2,3,4,
  • Zhenzhen Hui1,2,3,4,
  • Xiao Tian1,2,3,4,
  • Shui Cao1,2,3,4,
  • Weijiao Du1,2,3,4,
  • Wenwen Yu1,2,3,5,
  • Liang Liu1,2,3,4,
  • Xinwei Zhang1,2,3,4 &
  • …
  • Xiubao Ren1,2,3,4,5 

Scientific Reports , Article number:  (2026) Cite this article

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We are providing an unedited version of this manuscript to give early access to its findings. Before final publication, the manuscript will undergo further editing. Please note there may be errors present which affect the content, and all legal disclaimers apply.

Subjects

  • Cancer
  • Immunology
  • Oncology

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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Data availability

All data supporting the findings of this study are available within the article or its Supplementary Information.

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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.

Author information

Authors and Affiliations

  1. Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, 300060, China

    Shuzhan Li, Jing Qin, Qian Sun, Hua Zhao, Yanjuan Xiong, Yang Wang, Ying Han, Jiali Zhang, Weihong Zhang, Meng Shen, Fan Yang, Baozhu Ren, Li Zhou, Runmei Li, Zhenzhen Hui, Xiao Tian, Shui Cao, Weijiao Du, Wenwen Yu, Liang Liu, Xinwei Zhang & Xiubao Ren

  2. Tianjin’s Clinical Research Center for Cancer, Tianjin, 300060, China

    Shuzhan Li, Jing Qin, Qian Sun, Hua Zhao, Yanjuan Xiong, Yang Wang, Ying Han, Jiali Zhang, Weihong Zhang, Meng Shen, Fan Yang, Baozhu Ren, Li Zhou, Runmei Li, Zhenzhen Hui, Xiao Tian, Shui Cao, Weijiao Du, Wenwen Yu, Liang Liu, Xinwei Zhang & Xiubao Ren

  3. Key Laboratory of Cancer Immunology and Biotherapy, Tianjin, 300060, China

    Shuzhan Li, Jing Qin, Qian Sun, Hua Zhao, Yanjuan Xiong, Yang Wang, Ying Han, Jiali Zhang, Weihong Zhang, Meng Shen, Fan Yang, Baozhu Ren, Li Zhou, Runmei Li, Zhenzhen Hui, Xiao Tian, Shui Cao, Weijiao Du, Wenwen Yu, Liang Liu, Xinwei Zhang & Xiubao Ren

  4. Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin, 300060, China

    Shuzhan Li, Yanjuan Xiong, Yang Wang, Ying Han, Jiali Zhang, Weihong Zhang, Meng Shen, Fan Yang, Baozhu Ren, Li Zhou, Runmei Li, Zhenzhen Hui, Xiao Tian, Shui Cao, Weijiao Du, Liang Liu, Xinwei Zhang & Xiubao Ren

  5. Department of Immunology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, 300060, China

    Jing Qin, Qian Sun, Hua Zhao, Wenwen Yu & Xiubao Ren

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Contributions

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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Correspondence to Shuzhan Li, Jing Qin, Liang Liu, Xinwei Zhang or Xiubao Ren.

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This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Tianjin Medical University Cancer Hospital and Institute (No. E2017232). All patients provided written informed consent for their involvement and for the publication of the results.

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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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  • Received: 06 October 2025

  • Accepted: 31 January 2026

  • Published: 07 February 2026

  • DOI: https://doi.org/10.1038/s41598-026-38881-1

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Keywords

  • Refractory clear cell renal cell carcinoma
  • Anti-angiogenic agents
  • anti-PD-1 antibody
  • Autologous cytokine-induced killer cell therapy
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