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<p>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, <i>n</i> = 12) or camrelizumab combined with CIK cell re-transfusion (trial group, <i>n</i> = 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<sup>+</sup> 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.</p><p><b>Registry: ClinicalTrials.gov, TRN: NCT03987698, Registration date: 17 June 2019.</b></p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月7日

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  • 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

摘要

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.