Chang Chen, Cai Zhaolun, Cheng Ke, Shen Chaoyong, Zhang Bo, Chen Zhixin, Yin Yuan, Cao Dan
Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichuan University, No.37 Guoxue Alley, Chengdu, 610041, Sichuan, China.
Gastric Cancer Center, Department of General Surgery, West China Hospital, Sichuan University, No.37 Guoxue Alley, Chengdu, 610041, Sichuan, China.
Updates Surg. 2025 Jan;77(1):165-174. doi: 10.1007/s13304-024-02052-6. Epub 2024 Dec 30.
Gastric cancer, as the fifth most diagnosed malignancy and the fourth leading cause of cancer-related death globally, remains a significant health concern. The potential effect of the programmed death-1 (PD-1) inhibitor, when used alongside chemotherapy and antiangiogenic agents in neoadjuvant therapy for gastric cancer, has yet to be explored in the published literature. This study aims to evaluate the efficacy and safety of the S-1 plus oxaliplatin (SOX) regimen when combined with apatinib and camrelizumab (SOXAC) as neoadjuvant therapy for patients with locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. A single-arm, open-label, single-center phase II clinical trial has been designed to evaluate the safety and efficacy of the SOXAC regimen as neoadjuvant therapy for patients diagnosed with locally advanced gastric or GEJ adenocarcinoma (cT2-3N + M0 or T4NxM0). Eligible patients are to receive 2 cycles of SOXAC and 1 cycle of SOX regimen with camrelizumab (SOXC) as neoadjuvant therapy prior to radical surgery, and 3 cycles of SOXC as postoperative adjuvant therapy. The primary endpoint is major pathological remission (MPR), while secondary endpoints include pathological complete response (pCR) rate, R0 resection rate, objective response rate (ORR), operation-related outcomes, and safety. The SOX regimen remains a leading choice for neoadjuvant chemotherapy in Eastern countries. Recent studies suggest that combining chemotherapy, targeted agents, and immune checkpoint inhibitors can enhance the antitumor immune response. This phase II clinical trial seeks to assess the safety and efficacy of the SOXAC regimen as neoadjuvant therapy for patients with locally advanced resectable gastric or GEJ adenocarcinoma, while also exploring the correlation between biomarkers and efficacy.Trial Registration Chinese Clinical Trial Registry (ChiCTR): ChiCTR2200062285 ( https://www.chictr.org.cn/ ).
胃癌是全球第五大最常被诊断出的恶性肿瘤，也是癌症相关死亡的第四大主要原因，仍然是一个重大的健康问题。程序性死亡-1（PD-1）抑制剂在胃癌新辅助治疗中与化疗和抗血管生成药物联合使用时的潜在效果，在已发表的文献中尚未得到探索。本研究旨在评估S-1联合奥沙利铂（SOX）方案与阿帕替尼和卡瑞利珠单抗联合（SOXAC）作为局部晚期胃癌或胃食管交界（GEJ）腺癌患者新辅助治疗的疗效和安全性。一项单臂、开放标签、单中心的II期临床试验已被设计用于评估SOXAC方案作为诊断为局部晚期胃癌或GEJ腺癌（cT2-3N+M0或T4NxM0）患者新辅助治疗的安全性和疗效。符合条件的患者在根治性手术前接受2个周期的SOXAC和1个周期的含卡瑞利珠单抗的SOX方案（SOXC）作为新辅助治疗，术后接受3个周期的SOXC作为辅助治疗。主要终点是主要病理缓解（MPR），次要终点包括病理完全缓解（pCR）率、R0切除率、客观缓解率（ORR）、手术相关结局和安全性。SOX方案仍然是东方国家新辅助化疗的首选。最近的研究表明，联合化疗、靶向药物和免疫检查点抑制剂可以增强抗肿瘤免疫反应。这项II期临床试验旨在评估SOXAC方案作为局部晚期可切除胃癌或GEJ腺癌患者新辅助治疗的安全性和疗效，同时还探索生物标志物与疗效之间的相关性。试验注册中国临床试验注册中心（ChiCTR）：ChiCTR2200062285（https://www.chictr.org.cn/）
