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NCT Number: NCT07662070

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Not applicable- observational study

Other

Not applicable- observational study

Primary outcomes

  1. 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

    Defined as 10% or less residual viable tumor cells in the resected primary tumor specimen after perioperative immunotherapy

Secondary outcomes

  1. 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

    Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and all examined regional lymph nodes after completion of neoadjuvant immunotherapy and curative surgery.

  2. Event-Free Survival (EFS)

    Time frame: From enrollment up to 24 months

    Event-free survival is defined as the time from study enrollment to the first occurrence of any of the following events: disease progression during neoadjuvant treatment, failure to undergo curative surgery, postoperative recurrence, or death from any cause.

  3. Overall Survival (OS)

    Time frame: From enrollment up to 36 months

    Overall survival is defined as the time from study enrollment to death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Qing Li, PhD/MD

CONTACT

[email protected]

+8618702848178

Sponsors and collaborators

Lead sponsor

West China Second University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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