Emotional Distress and Pathologic Response in Locally Advanced Gastric/GEJ Adenocarcinoma
2026年6月17日 更新者：Ting Liu、West China Second University Hospital
A Prospective Observational Study of the Association Between Pretreatment Emotional Distress and Pathologic Response to Perioperative Immunotherapy in Locally Advanced Gastric/Gastroesophageal Junction 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.
調査の概要
研究の種類
観察的
入学 (推定)
120
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Qing Li, PhD/MD
- 電話番号：+8618702848178
- メール：liqing@scu.edu.cn
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Adults with histologically confirmed, resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma who are planned to receive neoadjuvant/perioperative immunotherapy followed by curative-intent surgery at West China Hospital.
Eligible participants must have stage II-III disease without distant metastasis, an ECOG performance status of 0-1, no prior systemic antitumor treatment for the current tumor at baseline, and the ability to complete questionnaire assessments before and during treatment.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Pretreatment Emotional Distress
Participants with pretreatment emotional distress, defined as a PHQ-9 score of 5 or higher and/or a GAD-7 score of 5 or higher before initiation of perioperative immunotherapy.
These participants will receive standard perioperative immunotherapy and routine clinical care according to the treating physician's plan.
This observational study will compare pathologic response and clinical outcomes between participants with and without pretreatment emotional distress.
|
該当なし - 観察研究
|
|
No Pretreatment Emotional Distress
Participants without pretreatment emotional distress, defined as a PHQ-9 score lower than 5 and a GAD-7 score lower than 5 before initiation of perioperative immunotherapy.
These participants will receive standard perioperative immunotherapy and routine clinical care according to the treating physician's plan.
This observational study will compare pathologic response and clinical outcomes between participants with and without pretreatment emotional distress.
|
該当なし - 観察研究
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
major pathological response
時間枠：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
|
Assessed on surgical pathology after completion of neoadjuvant treatment and curative resection, approximately 6 to 12 weeks after treatment initiation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pathological Complete Response (pCR)
時間枠：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.
|
Assessed on surgical pathology at the time of curative resection, approximately 6 to 12 weeks after initiation of perioperative immunotherapy
|
|
Event-Free Survival (EFS)
時間枠：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.
|
From enrollment up to 24 months
|
|
Overall Survival (OS)
時間枠：From enrollment up to 36 months
|
Overall survival is defined as the time from study enrollment to death from any cause.
|
From enrollment up to 36 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月26日
一次修了 (推定)
2028年7月1日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年6月17日
QC基準を満たした最初の提出物
2026年6月17日
最初の投稿 (実際)
2026年6月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月23日
QC基準を満たした最後の更新が送信されました
2026年6月17日
最終確認日
2026年6月1日
詳しくは
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その他の研究ID番号
- ED-GCGEJ
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