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

• Conditions: Stomach Cancer

• Registration Number: NCT04819958
• Lead Sponsor: Fujian Medical University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-29
• Study Start: 2021-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-15
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year disease free survival rate	36 months	3-year disease free survival rate

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Gastric Surgery; 🇨🇳 Fuzhou, Fujian, China