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Recruiting NCT06786169

The Relationship of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer

— Observational Gastric Cancer, Gastroesophageal Junction Cancer

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: psychological stress status.
Who it may be relevant to
Registry conditions: Gastric Cancer, Gastroesophageal Junction Cancer. Basic parameters: 18 years — 80 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
China
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

Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer (G-STRESS)

Overview

This is the prospective, observational cohort study (G-Distress) to explore the associations of psychological stress with treatment and prognosis of gastric cancer. The participants including the patients diagnosed with gastric cancer who received surgery, chemotherapy and immune checkpoint inhibitors.

Interventions

  • Other psychological stress status
    The assessment of depressive and anxiety symptoms was conducted using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment 7 (GAD-7). Patients with a PHQ-9 score ≥ 5 or a GAD-7 score ≥ 5 were categorized as the stressed group.

Primary outcome measures

  • Cohort 1: Disease-free survival (DFS) [Time frame: 3-year]
  • Cohort 2: Pathologic complete response (pCR) rate [Time frame: 1-month]
  • Cohort 3: Progression-free survival (PFS) [Time frame: 1-year]
Secondary outcome measures (3)
  • Overall survival (OS) [Time frame: 3-year]
  • Objective Response Rate [Time frame: through study completion, an average of 1 year]
  • Quality of life assessed by EORTC QLQ-C30. [Time frame: 3-year]

Eligibility criteria

Cohort 1

Inclusion criteria

  • Lower age limit of research subjects 18 years old and upper age limit of 80 years old, ECOG (ECOG score standard) performance status of 0 or 1
  • Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences
  • R0 gastrectomy with D2 lymphadenectomy
  • Receiving adjuvant chemotherapy

Exclusion criteria

  • History of chemotherapy, radiotherapy, immunotherapy or target therapy
  • Multiple primary tumors
  • Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
  • Unavailable for R0 resection and D2 lymph node dissection.
  • Patients with stage IV gastric cancer

Cohort 2

Inclusion criteria

  • Lower age limit of research subjects 18 years old and upper age limit of 80 years old, ECOG (ECOG score standard) performance status of 0 or 1
  • Be proven to be primary adenocarcinoma of gastric cancer and staged III-IV by pathological evidences
  • Receiving gastrectomy
  • Receiving preoperative chemotherapy

Exclusion criteria

  • Unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy
  • Multiple primary tumors
  • Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
  • Unavailable for gastrectomy

Cohort 2

Inclusion criteria

  • Lower age limit of research subjects 18 years old and upper age limit of 80 years old, ECOG (ECOG score standard) performance status of 0 or 1
  • Be proven to be primary adenocarcinoma of gastric cancer and staged IV by pathological evidences
  • Unavailable for gastrectomy
  • Presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1

Exclusion criteria

  • Unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy
  • Multiple primary tumors
  • Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases

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

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT06786169 · G-STRESS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗