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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Immunological Heterogeneity of Tumor Microenvironment in the Short-term Outcome and Long-term Outcome of Patients With Gastric Cancer

Conditions
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Stomach Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 80 years Histology confirmed gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy. Clinical stage: cTNM: stage I or above at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day) Clinically fit for gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function. Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection History of other malignant diseases within the past five years History of unstable angina or myocardial infarction within the past six months History of a cerebrovascular accident within the past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for other diseases Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer Forced expiratory volume in 1 second (FEV1)<50% of predicted values Inclusion in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overall survival rate | 3-year overall survival rate | 36 months | 
| Morbidity rates | This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery. | 30 days | 
| Mortality rates | This is for the early mortality, which defined as the event observed within 30 days after surgery. | 30 days | 
| Total number of retrieved lymph nodes | Total number of retrieved lymph nodes after surgery | One month after surgery | 
| Intraoperative morbidity rates | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. | 1 day | 
| The variation of white blood cell count | The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. | Preoperative 7 days and postoperative 1, 3, and 5 days | 
| The variation of hemoglobin | The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. | Preoperative 7 days and postoperative 1, 3, and 5 days | 
| The variation of C-reactive protein | The values of C-reactive protein in milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response | Preoperative 7 days and postoperative 1, 3, and 5 days | 
| 3-year recurrence pattern | Recurrence patterns are classified into four categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, and mixed type | 36 months | 
| Time to first ambulation | Time to first ambulation in days is used to assess the postoperative recovery course. | 30 days | 
| Time to first flatus | Time to first flatus in days is used to assess the postoperative recovery course. | 30 days | 
| Time to first liquid diet | Time to first liquid diet in days is used to assess the postoperative recovery course. | 30 days | 
| Time to first soft diet | Time to first soft diet in days is used to assess the postoperative recovery course. | 30 days | 
| Duration of postoperative hospital stay | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days |