Link between psychological distress and immune therapy response in gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll adults with gastric adenocarcinoma who are planned to receive preoperative immune checkpoint inhibitors followed by radical gastrectomy at a single tertiary center. Investigators will measure psychological distress and related biomarkers (for example cortisol and catecholamines), immune parameters such as CD8+ T cells, and clinical/pathologic treatment responses. The study will look for correlations between distress measures, immune markers, and short-term outcomes after neoadjuvant immunotherapy and surgery. Findings aim to identify whether stress-related signals are associated with reduced immunotherapy effectiveness and could point to interventions to modify that risk.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Xinhua Chen, Ph.D
• Email: xinhuachen03@163.com
• Phone: 8615626452302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.