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Correlation of Psychological Distress and Immune Checkpoint Inhibitors in Gastric Cancer

Recruitingn/aAges 18 Years - 75 YearsAllNanfang Hospital, Southern Medical University
NCT07003334 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

1. Background Gastric cancer (GC) is a leading global cause of cancer-related mortality, with over 1 million new cases and 769,000 deaths in 2020. In China, 80% of patients present with advanced disease, for whom perioperative chemotherapy, surgery, and lymphadenectomy are standard. Recent phase III trials (Checkmate-649, KEYNOTE-062, ORIENT-16) demonstrate that immune checkpoint inhibitors (ICIs) combined with chemotherapy improve progression-free survival (PFS: 2.8-10.5 months) and overall survival (OS: 11.1-18.4 months) compared to chemotherapy alone. However, outcomes remain suboptimal, necessitating exploration of novel predictive biomarkers and resistance mechanisms. Emerging evidence implicates chronic stress in cancer progression and treatment response. Chronic stress activates the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system, elevating cortisol, c

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📋 Eligibility rules (as published)
Inclusion Criteria: * Voluntary signing of informed consent; * 18≦ age ≦75 years; * Sex: no limitation; * Patients with gastric adenocarcinoma diagnosed according to the 15th edition of the Japanese gastric cancer statute, 2017, after endoscopic biopsy of the primary lesion; * Patients requiring preoperative immune checkpoint inhibitor therapy at the discretion of the treating physician, followed by radical gastrectomy. Exclusion Criteria: * Women who are pregnant or breastfeeding; * Serious mental illness; * History of upper abdominal surgery (except for laparoscopic cholecystectomy) ; * Patients with gastric cancer who do not wish to undergo neoadjuvant immunotherapy; * Patients with a history of continuous systemic corticosteroid therapy within the past 1 month; * Patients with active infection, active or refractory autoimmune disease, or uncontrolled systemic disease; * Patients at the discretion of the investigator, were deemed unsuitable for participation in this study.
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What it tests

  • Not listed
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Where

1 site
Nanfang Hospital, Southern Medical University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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