BMJ open · 2025
Efficacy and safety of HIPEC combined with PD-1 and SOX chemotherapy for gastric or oesophagogastric junctional cancer with peritoneal metastasis (HISTORIA): protocol for a prospective, multicentre, single-arm, phase II study.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Zhang Yigang, Li Fengyuan, Liu Hongda, Li Ping, Li Qingya, Wang Linjun, Zhang Diancai, Wu Hao, Xu Hao, Yang Li, Xu Ze-Kuan
Аннотация
INTRODUCTION: 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.
METHODS AND ANALYSIS: 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/m2, 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.
PRIMARY ENDPOINT: 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.
ETHICS AND DISSEMINATION: 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.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT06427252.
METHODS AND ANALYSIS: 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/m2, 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.
PRIMARY ENDPOINT: 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.
ETHICS AND DISSEMINATION: 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.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT06427252.
Предметные рубрики MeSH
HumansStomach NeoplasmsPeritoneal NeoplasmsEsophagogastric JunctionAdultOxaliplatinMiddle AgedHyperthermic Intraperitoneal ChemotherapyProspective StudiesAntineoplastic Combined Chemotherapy ProtocolsAgedMaleClinical Trials, Phase II as TopicFemaleOxonic AcidDrug CombinationsAntibodies, Monoclonal, HumanizedAdolescentEsophageal NeoplasmsMulticenter Studies as TopicYoung AdultCombined Modality TherapyChinaTegafur