Correlation of Psychological Distress and Immune Checkpoint Inhibitors in Gastric Cancer

NCT07003334 | Recruiting DMC

• 2 other identifiers: NFEC-2024-362Nanfang Hospital
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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.
2. 2.Objectives
3. 3.Study Endpoints
4. 4.Study Design Type: Single-center, prospective observational study. Duration: 36 months. Sample Size: 268 patients (134 high chronic stress, 134 low chronic stress).
5. 5.Methods
6. 6.Significance This study addresses a critical gap in understanding how psychological factors modulate ICI efficacy. By identifying chronic stress as a predictor of treatment response, results may guide personalized interventions (e.g., beta-blockers, behavioral therapy) to improve outcomes in advanced gastric cancer.

Conditions

Gastric Cancers

Keywords

Psychological Distress; Immune Checkpoint Inhibitors; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor Regression Grade （TRG）

  Tumor Regression Grade (TRG) is a histopathological scoring system used to assess the degree of tumor response to neoadjuvant therapy (e.g., chemotherapy or radiation) in resected specimens. It quantifies residual viable tumor cells versus treatment-induced fibrosis or necrosis, providing prognostic and therapeutic guidance.

  7 Days

Study Arms (1)

Gastric cancer patients who plan to reveive immune checkpoint inhibitors treatment

As this was an observational study, no additional visits or laboratory analyses or assessments other than those required by routine, clinical practice were required. Patients must sign an updated informed consent form (ICF- approved by Ethics Committeettee) before performing data collection. After obtaining the patient's informed consent, the patient's clinical routine diagnosis and treatment information will be collected; We collected psychological assessment questionnaires, quality of life assessment questionnaires, serum cortisol, corticotropin (ACTH) , plasma epinephrine (Epi) , and noradrenaline (NE) 、serotonin along with clinical diagnosis and treatment nodes, data, the number and time of the study visits were according to the time points of the routine clinical patient review ( peritoneal exploration for advanced gastric cancer, 4 cycles of immunotherapy/combined chemotherapy before surgery, surgery, treatments after surgery) .

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population was patients with gastric cancer who were scheduled for laparoscopic gastrectomy after preoperative immunotherapy.

You may qualify if:

• Voluntary signing of informed consent;
• ≦ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum cortisol， Adrenocorticotropic Hormone (ACTH)，Plasma epinephrine (Epi)，Norepinephrine (NE)，Serotonin (5-HT)

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Xinhua Chen, Ph.D

CONTACT

8615626452302; xinhuachen03@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: January 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)