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Not yet recruiting NCT07662070

Emotional Distress and Pathologic Response in Locally Advanced Gastric/GEJ Adenocarcinoma

— Observational Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Emotional Distress Pathologic Response

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Not applicable- observational study.
Who it may be relevant to
Registry conditions: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Emotional Distress, Pathologic Response. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Observational Study of the Association Between Pretreatment Emotional Distress and Pathologic Response to Perioperative Immunotherapy in Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

Overview

This is a single-center, prospective observational cohort study designed to evaluate the association between pretreatment emotional distress and pathologic response to perioperative immunotherapy in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 120 patients planned for neoadjuvant immunotherapy followed by curative surgery will be enrolled. Emotional distress will be assessed using the PHQ-9 and GAD-7 before treatment initiation and at prespecified time points during treatment. Participants will be classified into an emotional distress group or a non-emotional distress group according to predefined criteria. The primary endpoint is major pathological response (MPR). Secondary endpoints include pathological complete response (pCR), R0 resection rate, event-free survival (EFS), recurrence-free survival (RFS), and overall survival (OS). Exploratory analyses will assess dynamic changes in emotional distress and their associations with peripheral stress markers, peripheral immune markers, and tumor immune microenvironment features.

Interventions

  • Other Not applicable- observational study
    Not applicable- observational study

Primary outcome measures

  • major pathological response [Time frame: Assessed on surgical pathology after completion of neoadjuvant treatment and curative resection, approximately 6 to 12 weeks after treatment initiation]
Secondary outcome measures (3)
  • Pathological Complete Response (pCR) [Time frame: Assessed on surgical pathology at the time of curative resection, approximately 6 to 12 weeks after initiation of perioperative immunotherapy]
  • Event-Free Survival (EFS) [Time frame: From enrollment up to 24 months]
  • Overall Survival (OS) [Time frame: From enrollment up to 36 months]

Eligibility criteria

Inclusion criteria

  • Willing to participate in this study.
  • Age >18 years; both sexes are eligible.
  • Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
  • Resectable locally advanced disease as assessed by imaging and/or multidisciplinary team evaluation, generally corresponding to AJCC 8th edition stage II-III disease, including cT3-4a with any N category or any T with node-positive disease, without distant metastasis.
  • Planned to receive neoadjuvant therapy followed by curative-intent surgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • No prior systemic antitumor treatment for the current tumor at baseline.
  • Able to understand and complete questionnaire assessments.
  • Able and willing to provide written informed consent.

Exclusion criteria

  • Presence of distant metastasis, peritoneal metastasis, or loss of curative treatment opportunity as determined by clinical evaluation.
  • Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic antitumor treatment for the current tumor.
  • Severe cognitive impairment, acute psychiatric disorder, or any condition that precludes completion of questionnaire assessments.
  • Current treatment with antidepressants, anxiolytics, or other psychotropic medications with any of the following within 4 weeks before baseline assessment: initiation, discontinuation, change in medication type, dose adjustment of 50% or more, or addition of a second or more psychotropic medication.
  • Any other condition judged by the investigator to make the participant unsuitable for enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07662070 · ED-GCGEJ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗