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The Effect of Immunological Heterogeneity of Tumor Microenvironment in the Prognosis of Gastric Cancer

F

Fujian Medical University

Status

Unknown

Conditions

Stomach Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04819958
FUGES-B01

Details and patient eligibility

About

The purpose of this study is to explore the effect of immunological heterogeneity of tumor microenvironment in the short-term outcome and long-term outcome of patients with gastric cancer.

Full description

A prospective cohort study will be performed to explore the effect of immunological heterogeneity of tumor microenvironment in the short-term outcome and long-term outcome of patients with gastric cancer. The evaluation parameters are perioperative clinical efficacy, postoperative complications, and 3-year survival and recurrence rates.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age from 18 to 80 years
  2. Histology confirmed gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy.
  3. Clinical stage: cTNM: stage I or above at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition
  4. Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
  5. Clinically fit for gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
  6. Written informed consent

Exclusion criteria

  1. Women during pregnancy or breast-feeding
  2. Severe mental disorder
  3. History of previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection
  4. History of other malignant diseases within the past five years
  5. History of unstable angina or myocardial infarction within the past six months
  6. History of a cerebrovascular accident within the past six months
  7. History of continuous systematic administration of corticosteroids within one month
  8. Requirement of simultaneous surgery for other diseases
  9. Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer
  10. Forced expiratory volume in 1 second (FEV1)<50% of predicted values
  11. Inclusion in another clinical trial

Trial contacts and locations

1

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Central trial contact

Changming Huang, MD; Qing Zhong

Data sourced from clinicaltrials.gov

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