Xiaoyan granule plus aptinib in patients with advanced gastric cancer who failed radiotherapy and chemotherapy: A prospective, phase II trial

Objective: Xiaoyan granule (XYG) is a type of Chinese medicine preparation, which has been confirmed as an adjuvant therapeutic scheme for the treatment of advanced gastric cancer (AGC). Apatinib has been recommended as a third-line treatment option for AGC. The purpose of this study was to evaluate the efficacy and safety of XYG combined with apatinib in the treatment of AGC patients who failed radiotherapy and chemotherapy. Methods 207 eligible patients were enrolled at the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine in this randomized controlled trial from January 2020 to December 2021. They were assigned to the treatment group to receive XYG combined with apatinib (n = 100) or to the control group to accept apatinib (n = 107, among which 7 patients were lost to follow-up). Patients with stable status continued to be treated (28 days as a course of treatment) until disease progression or unaccepted toxicity occurred. The primary endpoint was progression-free survival (PFS). The secondary endpoints were objective response rate (ORR), disease control rate (DCR), and safety. Results In contrast to the control group, patients in the treatment group were able to significantly prolong PFS (6.67 vs 4.00 months, P  < 0.05). The second endpoints of the treatment group were also remarkably improved (ORR: 46.0% vs 41.0%, P  < 0.05; DCR: 82.0% vs 69.0%, P  < 0.05). In terms of safety, there was no statistical difference in any grade of adverse events between the two groups. The treatment group could significantly reduce the incidence of grade III-IV adverse events. Conclusion The synergistic effect of XYG combined with apatinib could prolong the survival time and improve the safety of AGC patients who failed radiotherapy and chemotherapy.