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

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

doi:10.1186/s12575-025-00309-x

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

Biol Proced Online. 2025 Dec 30;27(1):54. doi: 10.1186/s12575-025-00309-x.

Authors

Tingting Wu^#¹, Shiying Li^#², Hui Shuang^#³, Yun Li¹, Shujuan Fu¹, Haiyan Jiang¹, Shiqiang Zhang¹, Boqian Du¹, Junqiang Lv¹, Xiaoting Xia¹, Shengcheng Cao³, Liping Yao³, Pingsheng Pan³, Siqi Feng², Cunya Li², Zhangjie Zhou⁴, Jian Chen⁵, Yi Zhong⁶

Affiliations

¹ Oncology Department, Shanghai TCM-Integrated Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, 230 Baoding Road, Hongkou District, Shanghai, 200082, China.
² Shanghai University of Traditional Chinese Medicine, Shanghai, China.
³ Oncology Department, Songjiang Fangta Chinese Medicine Hospital, Shanghai, China.
⁴ Oncology Department, Shanghai TCM-Integrated Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, 230 Baoding Road, Hongkou District, Shanghai, 200082, China. 455432398@qq.com.
⁵ Institute of Vascular Anomalies, Shanghai TCM-Integrated Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, 230 Baoding Road, Hongkou District, Shanghai, 200082, China. alexandercj@126.com.
⁶ Oncology Department, Shanghai TCM-Integrated Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, 230 Baoding Road, Hongkou District, Shanghai, 200082, China. zhongzixian2000@163.com.

^# Contributed equally.

Abstract

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.

Keywords: Immunotherapy; Intestinal barrier; PD-1 monoclonal antibody; Pancancer; Xianglian granules.

Abstract

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