Zhang Yigang, Li Fengyuan, Liu Hongda, Li Ping, Li Qingya, Wang Linjun, Zhang Diancai, Wu Hao, Xu Hao, Yang Li, Xu Ze-Kuan
Gastric Cancer Center, The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China.
The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China.
BMJ Open. 2025 Sep 14;15(9):e098326. doi: 10.1136/bmjopen-2024-098326.
Despite advances in diagnostics, many patients with gastric cancer (GC) or oesophagogastric junction cancer present with advanced disease, most commonly peritoneal metastasis (PM), which conveys a poor prognosis. Hyperthermic intraperitoneal chemotherapy (HIPEC) and anti-programmed cell death protein-1 (PD-1) therapy have each shown promise in GC. We describe the protocol for a study evaluating the efficacy and safety of combining HIPEC with the anti-PD-1 antibody tislelizumab and SOX (oxaliplatin+S-1) chemotherapy in patients with GC/oesophagogastric junction cancer and PM.
This is a multicentre, single-arm, phase II trial conducted at 13 high-volume tertiary referral hospitals across China. We will enrol 50 adults (18-75 years) with histologically confirmed GC/oesophagogastric junction adenocarcinoma and PM diagnosed by laparoscopy. Participants will receive one laparoscopy-guided HIPEC cycle (paclitaxel, total dose: 175 mg/m, 3000 mL of physiological saline at 43°C for 60 min, inflow rate 1.5 L/min, 10 min physiological saline preconditioning at 41°C) followed-after a 3-week interval-by up to three 3-week cycles of tislelizumab 200 mg plus SOX (oxaliplatin 130 mg/m² and S-1 dose-escalated by body surface area). HER2-positive patients will also receive trastuzumab.
1-year overall survival. Secondary endpoints: 1-year progression-free survival, completeness of Cytoreduction Score and objective response rate. Follow-up includes imaging and toxicity assessments every 3 months for at least 1 year.
The protocol was approved by the Ethics Committee of The First Affiliated Hospital of Nanjing Medical University (ID 2024-SR-198). All participants will provide written informed consent. Results will be disseminated via peer-reviewed publications; de-identified individual participant data will be available from the corresponding author on reasonable request after publication.
ClinicalTrials.gov, NCT06427252.
尽管诊断技术有所进步，但许多胃癌（GC）或食管胃交界癌患者就诊时已处于晚期，最常见的是腹膜转移（PM），预后较差。腹腔热灌注化疗（HIPEC）和抗程序性细胞死亡蛋白1（PD-1）治疗在GC治疗中均显示出前景。我们描述了一项研究方案，该研究旨在评估HIPEC联合抗PD-1抗体替雷利珠单抗及SOX（奥沙利铂+S-1）化疗在GC/食管胃交界癌伴PM患者中的疗效和安全性。
这是一项在中国13家大型三级转诊医院进行的多中心、单臂、II期试验。我们将纳入50名年龄在18至75岁之间、经组织学确诊为GC/食管胃交界腺癌且经腹腔镜诊断为PM的成年人。参与者将接受一个腹腔镜引导下的HIPEC周期（紫杉醇，总剂量：175mg/m²，43℃的生理盐水3000mL，持续60分钟，流速1.5L/分钟，41℃的生理盐水预处理10分钟），间隔3周后，接受最多三个为期3周的周期，替雷利珠单抗200mg联合SOX（奥沙利铂130mg/m²，S-1根据体表面积进行剂量递增）。HER2阳性患者还将接受曲妥珠单抗治疗。
1年总生存率。次要终点：1年无进展生存率、细胞减灭评分的完整性和客观缓解率。随访包括每3个月进行一次影像学和毒性评估，至少持续1年。
该方案已获得南京医科大学第一附属医院伦理委员会批准（编号2024-SR-198）。所有参与者将提供书面知情同意书。研究结果将通过同行评审出版物进行传播；经过去识别处理的个体参与者数据将在发表后，可应相应作者的合理要求提供。
ClinicalTrials.gov，NCT06427252。
