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Gastric CancersPDICINCT07003334

Correlation of Psychological Distress and Immune Checkpoint Inhibitors in Gastric Cancer

An observational study of Gastric Cancers, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancers
How many people
268 participants
Where
1 siteChina
Study dates
3 Jan 2025to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xinhua Chen, Ph.D contact

8615626452302

xinhuachen03@163.com

China1 site, 1 recruiting
  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    Xinhua Chen, Ph.D, 866-278-7625 ext. 15626452302, xinhuachen03@163.com

    Jiang Yu, Ph.D, 866-278-7625 ext. 13829723956, balbcyujiang@163.com

    Recruiting

Other trials in China

About this study

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

  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, catecholamines, and glucocorticoids. These hormones suppress immune function by reducing CD8+ T cells and natural killer (NK) cell activity while increasing immunosuppressive cells (e.g., regulatory T cells, myeloid-derived suppressor cells). Preclinical studies link chronic stress to metastasis via extracellular trap (NET) formation, impaired antitumor immunity, and resistance to PD-1/PD-L1 blockade. Clinically, chronic stress correlates with worse survival in non-small-cell lung cancer patients receiving ICIs. Despite these findings, psychological screening remains underutilized in oncology. This study aims to investigate the impact of chronic stress on ICI efficacy in advanced gastric cancer.
  2. Objectives Primary Objective: Evaluate the association between chronic stress and tumor response (via Tumor Regression Grade, TRG) in advanced gastric cancer patients undergoing neoadjuvant immunotherapy. Secondary Objectives: Assess the effect of chronic stress on post-gastrectomy quality of life (QoL). Analyze correlations between chronic stress biomarkers and survival outcomes (PFS, OS).
  3. Study Endpoints Primary Endpoint: Pathological response assessed by TRG (Mandard criteria). Secondary Endpoints: QoL (EORTC QLQ-C30/STO22 questionnaires). PFS and OS. Exploratory Endpoints: Dynamic changes in chronic stress biomarkers (serum cortisol, ACTH, epinephrine, norepinephrine, serotonin). Correlation of biomarker levels with TRG and survival.
  4. Study Design Type: Single-center, prospective observational study. Duration: 36 months. Sample Size: 268 patients (134 high chronic stress, 134 low chronic stress). Inclusion Criteria: Age 18-75 years. Histologically confirmed gastric adenocarcinoma (per Japanese Gastric Cancer Guidelines, 2017). Scheduled for neoadjuvant immunotherapy + radical gastrectomy. Informed consent. Exclusion Criteria: Pregnancy/breastfeeding. Prior upper abdominal surgery (excluding cholecystectomy). Active infection, autoimmune disease, or corticosteroid use within 1 month. Psychiatric disorders or investigator-deemed unsuitability. Withdrawal Criteria: Patient request, loss to follow-up, or safety concerns.
  5. Methods Chronic Stress Assessment: Validated psychological questionnaires (e.g., Hospital Anxiety and Depression Scale) at baseline and treatment milestones. Biomarker analysis: Serum cortisol, ACTH, epinephrine, norepinephrine, serotonin at key timepoints (pre-treatment, post-neoadjuvant therapy, post-surgery). Clinical Data Collection: TRG evaluation post-surgery. QoL assessments at 1, 3, 6, 12, 18, 24, and 36 months post-surgery. Survival tracking via hospital records and follow-up visits. Statistical Analysis: Stratification by baseline stress scores (high/low). Cox regression for survival outcomes; logistic regression for TRG-QoL correlations. Significance threshold: *p* < 0.05.
  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.
Read the detailed description

Gastric carcinoma (GC) remains a globally important cancer, with more than one million new cases and an estimated 769,000 deaths in 2020(equivalent to one in every 13 deaths worldwide) , it ranks fifth globally in incidence and fourth globally in mortality [1] . In China, 80% of gastric cancer patients are advanced, and the standard recommendation for locally advanced gastric cancer is perioperative adjuvant chemotherapy plus standard gastrectomy plus radical lymphadenectomy [2,3] . A series of large phase III studies (including Checkmate-649, ATTRACTION-04, KEYNOTE-062, ORIENT-16[4,5,6,7]) of completed ICI plus chemotherapy in gastric/esophageal/GEJ cancer showed a median PFS of 2.8 to 10.5 months for patients treated with ICI plus chemotherapy, median OS was 11.1-18.4 months. For advanced gastric/oesophagogastric junction gastric/oesophagogastric cancer, immunotherapy combined with chemotherapy versus first-line chemotherapy resulted in clinically meaningful PFS benefit, improved and durable objective responses, maintenance of HRQOL, and improved survival, also acceptable safety profile [4,5,6,7] , but the prognosis of advanced gastric cancer remains poor. There is still a lot of room for exploration to improve the efficacy of adjuvant therapy. It is imperative to find new predictive markers of immunotherapy efficacy, and explore the mechanism of drug resistance to immune checkpoint inhibitors.

In addition to genetic and tumor microenvironmental factors, psychological factors may also play a role in cancer treatment [8] . Chronic stress refers to the persistent non-specific adaptive response of the body triggered by the activation of the hypothalamic-pituitary-adrenal, glandular axis and sympathetic nervous system under the stimulation of physiological and psychological stressors, anxiety and depression. Chronic stress can affect the functioning of the immune system [9,12,13] . Related studies have shown that there may be different mechanisms by which chronic stress affects the progression and treatment of gastric cancer: depression induces neuroendocrine phenotypes through the catecholamine/β2-AR/MACC1 axis, thereby accelerating the invasion and metastasis of gastric cancer [6] ; Chronic stress, which activates the hypothalamic-pituitary-adrenal axis as well as the sympathetic nervous system, causes increased levels of cortisol, adrenergic hormones, the glucocorticoid released during chronic stress leads to the formation of NETs (extracellular traps) and the establishment of a microenvironment that promotes metastasis, which may contribute to the development of metastatic lesions, whereas digestion of NETs with DNase I in experimental mice prevents chronic stress-induced metastasis [11] . The stress-glucocorticoid-tsc22D3 axis can impair therapy-induced, antitumor immunity [12] . Preclinical studies have shown that pain-induced activation of the HPA axis and subsequent glucocorticoid, release can elicit anti-inflammatory effects, including apoptosis of T lymphocytes and neutrophil [13] . Endogenous glucocorticoids, the persistent release of hormones, also inhibit antigen presentation, further undermining systemic immune function [13] . In a large number of animals, studies have shown that exposure to chronic stress causes depression-like and anxiety-like symptoms in mice, thereby promoting tumor progression and metastasis [14,15,16] . Stress hormones can directly affect the malignant molecular characteristics of tumor cells [14,17,18] . Preclinical studies have shown that chronic stress also plays a potential role in promoting the development of the immunosuppressive tumor microenvironment [14,19,20] . Chronic stress exposure reduces CD8 + T cells and natural killer cells Proportion of cells and inhibit their function, while also increasing the infiltration of immunosuppressive cells such as regulatory T cells and myeloid-derived suppressor cells [12,19,21] . In mouse tumor models, studies have shown that chronic stress impairs the response to programmed cell death-1(PD-1)/PD-L1 blockade [12,22] . Chronic stress is also strongly associated with cancer, patient outcomes, and survival outcomes, as those with symptoms of depression or anxiety are at increased risk of relapse and Mortality[23]. However, screening and monitoring of psychological status in the clinic is often neglected and is not part of the current diagnosis and treatment routine [14] .

As immunotherapy becomes the cornerstone of treatment, it is crucial and important to study the relationship between chronic stress and the efficacy of ICIs. Studies have shown an association between chronic stress and worse clinical prognosis in patients with advanced non-small-cell lung carcinoma treated with ICIS, which highlights the potential significance of chronic stress in cancer management [24] . A 2020 study found that in colorectal cancer, β receptor and COX2 inhibition by preoperative propranolol/Idolac improved tumor metastasis, immunity, and inflammatory response-related markers [25] ; Similar results have been reported in breast cancer [26,27] . Psychological distress may have some predictive power for selected cancer presentations, including gastric cancer [28] . However, for gastric cancer, clinical evidence supporting the relationship between chronic stress and ICIS efficacy is limited, underscoring the need for prospective clinical studies.

Conditions
Gastric Cancers
Keywords
Psychological Distress, Immune Checkpoint Inhibitors, Gastric Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07003334
Study groupRoleWhat they receive
Gastric cancer patients who plan to reveive immune checkpoint inhibitors treatmentAs 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) .

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2025
  2. Study start3 Jan 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
268 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07003334
Sponsor's protocol ID
NFEC-2024-362
Other IDs
Nanfang Hospital
Acronym
PDICI
Status last verified
May 2025
First submitted
26 May 2025
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancers, run by Nanfang Hospital, Southern Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xinhua Chen, Ph.D (8615626452302, xinhuachen03@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Regression Grade (TRG) (time frame: 7 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

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