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Background <p>With the successive listing of immune checkpoint inhibitors in China, a new era of immunotherapy for malignant tumors has opened. However, this study has several limitations. Xianglian granule (XG), a Chinese herbal formula, has been proven to have a therapeutic effect on tumors in animal experiments. Our aim was to evaluate the efficacy and safety of XG combined with programmed death ligand 1 (PD-1) in pancancer patients through a randomized, double-blind, controlled trial.</p> Methods <p>Patients with cancer who received PD-1 monoclonal antibody therapy were randomized to the XG or control group according to the blinded method for 9&#xa0;weeks. The primary endpoint was the overall survival (OS) rate, and the secondary endpoint was the incidence rate of immune-related adverse events (irAEs). Related biological markers were observed.</p> Results <p>A total of 91 patients were included in the study. The 3-year OS rates of the XG group and the control group were 35.56% and 15.22%, respectively (<i>P</i> = 0.0012). The lactate dehydrogenase (LDH) level in the XG group was lower than that in the other groups, especially in the lung cancer patients (<i>P</i> = 0.06, <i>P</i> = 0.03). The two groups showed similar safety. The incidence rate of irAEs was 22.2% in the XG group and 32.6% in the control group (<i>P</i> = 0.27). In addition, XG can reduce D-lactic acid (D-LA) and diamine oxidase (DAO) contents (<i>P</i> = 0.012, <i>P</i> &lt; 0.001). The B lymphocyte count and percentage of the XG group increased (<i>P</i> = 0.04, <i>P</i> = 0.035), and the interleukin-2 level decreased (<i>P</i> = 0.045). The Cox regression results suggested that the potential factors of the prognostic model might be XG treatment, D-LA and B lymphocyte count (<i>P</i> = 0.002, <i>P</i> &lt; 0.001, <i>P</i> = 0.001).</p> Conclusion <p>XG had efficacy-enhancing and toxicity-reducing effects on pancancer patients when combined with a PD-1 monoclonal antibody. The mechanisms may be related to the participation of the intestinal barrier, B lymphocytes and interleukin-2. D-LA and B lymphocytes may be potential factors in the prognostic model of pancancer patients treated with immunotherapy.</p>

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Effect of the Addition of Xianglian Granules to PD-1 Monoclonal Antibodies in Pancancer Patients

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月30日

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  • Tingting Wu,
  • Shiying Li,
  • Hui Shuang,
  • Yun Li,
  • Shujuan Fu,
  • Haiyan Jiang,
  • Shiqiang Zhang,
  • Boqian Du,
  • Junqiang Lv,
  • Xiaoting Xia,
  • Shengcheng Cao,
  • Liping Yao,
  • Pingsheng Pan,
  • Siqi Feng,
  • Cunya Li,
  • Zhangjie Zhou,
  • Jian Chen,
  • Yi Zhong

摘要

Background

With the successive listing of immune checkpoint inhibitors in China, a new era of immunotherapy for malignant tumors has opened. However, this study has several limitations. Xianglian granule (XG), a Chinese herbal formula, has been proven to have a therapeutic effect on tumors in animal experiments. Our aim was to evaluate the efficacy and safety of XG combined with programmed death ligand 1 (PD-1) in pancancer patients through a randomized, double-blind, controlled trial.

Methods

Patients with cancer who received PD-1 monoclonal antibody therapy were randomized to the XG or control group according to the blinded method for 9 weeks. The primary endpoint was the overall survival (OS) rate, and the secondary endpoint was the incidence rate of immune-related adverse events (irAEs). Related biological markers were observed.

Results

A total of 91 patients were included in the study. The 3-year OS rates of the XG group and the control group were 35.56% and 15.22%, respectively (P = 0.0012). The lactate dehydrogenase (LDH) level in the XG group was lower than that in the other groups, especially in the lung cancer patients (P = 0.06, P = 0.03). The two groups showed similar safety. The incidence rate of irAEs was 22.2% in the XG group and 32.6% in the control group (P = 0.27). In addition, XG can reduce D-lactic acid (D-LA) and diamine oxidase (DAO) contents (P = 0.012, P < 0.001). The B lymphocyte count and percentage of the XG group increased (P = 0.04, P = 0.035), and the interleukin-2 level decreased (P = 0.045). The Cox regression results suggested that the potential factors of the prognostic model might be XG treatment, D-LA and B lymphocyte count (P = 0.002, P < 0.001, P = 0.001).

Conclusion

XG had efficacy-enhancing and toxicity-reducing effects on pancancer patients when combined with a PD-1 monoclonal antibody. The mechanisms may be related to the participation of the intestinal barrier, B lymphocytes and interleukin-2. D-LA and B lymphocytes may be potential factors in the prognostic model of pancancer patients treated with immunotherapy.