卡度尼利联合化疗一线治疗HER2阴性不可 切除的局部晚期或转移性胃/胃食管交界性腺癌疗效及安全性

Efficacy and Safety of Cabozantinib Combined Chemotherapy as First-Line Treatment for HER2-Negative Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

摘要: 胃癌(GC)是全球癌症相关死亡率的重要原因，目前HER-2阴性不可切除的局部晚期或转移性胃/胃食管交界性(G/GEJ)腺癌的一线化疗的响应率低、预后差、生存获益有限，患者需要新的治疗策略。研究评估了卡度尼利单抗联合化疗方案在HER-2阴性不可切除的局部晚期或转移性G/GEJ腺癌患者一线治疗中的疗效及安全性。研究在烟台毓璜顶医院进行，招募了HER-2阴性不可切除的局部晚期或转移性G/GEJ腺癌的患者。试验的主要终点为无进展生存期(Progression-Free Survival, PFS)，次要终点为总生存期(Overall Survival, OS)，疾病控制率(Disease control rate, DCR)，临床获益率(Clinical Benefit Rate, CBR)和安全性。采用常见不良事件通用术语标准5.0记录患者发生的不良反应并对其分级，由此探究卡度尼利单抗治疗中的疗效与安全性。2021年11月至2026年1月共筛选32例患者，2例患者被排除在外，30例患者符合纳入标准并完成了研究方案规定的治疗方案。患者接受卡度尼利单抗(10 mg/kg)，每3周与XELOX (奥沙利铂和卡培他滨)联合使用，最多6个周期，然后继续使用卡度尼利单抗单药治疗，剂量相同。中位PFS为7.9个月，大多数irAE为1级或2级，没有治疗相关的死亡病例。卡度尼利单抗联合化疗在HER2阴性不可切除的局部晚期或转移性G/GEJ腺癌患者的一线治疗中具有良好的疗效和安全性，有望成为该人群一线治疗的新选择。

Abstract: Gastric cancer (GC) is a leading cause of cancer-related mortality worldwide. Currently, first-line chemotherapy for HER-2-negative unresectable locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma has low response rates, poor prognosis, and limited survival benefits, necessitating new treatment strategies. This study evaluated the efficacy and safety of cadonilimab in combination with chemotherapy as first-line treatment for patients with HER-2-negative unresectable locally advanced or metastatic G/GEJ adenocarcinoma. The study was conducted at Yantai Yuhuangding Hospital and enrolled patients with HER-2 negative unresectable locally advanced or metastatic G/GEJ adenocarcinoma. The primary endpoint was progression-free survival (PFS), and secondary endpoints included overall survival (OS), disease control rate (DCR), clinical benefit rate (CBR), and safety. Adverse events were recorded and graded using the Common Adverse Events Criteria 5.0 to investigate the efficacy and safety of cadonilimab treatment. From November 2021 to January 2026, a total of 32 patients were screened. Two patients were excluded, and 30 patients met the inclusion criteria and completed the treatment regimen specified in the study protocol. Patients received cadonilimab (10 mg/kg) every 3 weeks in combination with XELOX (oxaliplatin and capecitabine) for a maximum of 6 cycles, followed by cadonilimab monotherapy at the same dose. The median progression-free survival (PFS) was 7.9 months, most irAEs were grade 1 or 2, and there were no treatment-related deaths. cadonilimab in combination with chemotherapy demonstrated good efficacy and safety in first-line treatment of patients with HER2-negative unresectable locally advanced or metastatic G/GEJ adenocarcinoma, and is expected to become a new first-line treatment option for this population.