Link between psychological distress and immune therapy response in gastric cancer

Correlation of Psychological Distress With Efficacy of Immune Checkpoint Inhibitors in Patients With Advanced Gastric Cancer

We will see if psychological distress influences how well immune checkpoint inhibitors work in adults with gastric adenocarcinoma receiving preoperative immunotherapy before surgery.

Quick facts

• Study type: Observational
• Enrollment: 268 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (other)
• Drugs / interventions: immunotherapy, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07003334 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with biopsy-proven gastric adenocarcinoma who are planned by their treating physician to receive preoperative immune checkpoint inhibitor therapy followed by radical gastrectomy, who can give informed consent, and who do not meet exclusion criteria.

Not a fit: Patients who are not receiving neoadjuvant immunotherapy, who have active uncontrolled infection or autoimmune disease, recent systemic corticosteroid use, serious mental illness, or who cannot travel to the study site are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could identify patients whose stress-related biology may reduce immunotherapy benefit and lead to targeted supportive care to improve treatment response.

How similar studies have performed: Large phase III trials have shown that adding immune checkpoint inhibitors to chemotherapy can improve outcomes in advanced gastric cancer, but using psychological distress as a predictive factor for immunotherapy response is a novel area with only preliminary supporting data.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Xinhua Chen, Ph.D

Conditions: Gastric Cancers, Psychological Distress, Immune Checkpoint Inhibitors, Gastric Cancer