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Clinical Trials/NCT06277453
NCT06277453
Active, not recruiting
Not Applicable

Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy: Multicenter Cohort Study

Fujian Medical University1 site in 1 country219 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Locally Advanced Gastric Cancer
Sponsor
Fujian Medical University
Enrollment
219
Locations
1
Primary Endpoint
3-year overall survival
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

To explore the effect of adjuvant chemotherapy cycles on the prognosis of this specific patient with lymph node-negative gastric cancer following neoadjuvant chemotherapy.

Detailed Description

We analyzed clinicopathological data from patients with lymph node-negative gastric cancer who underwent neoadjuvant chemotherapy at four institutions between 2010 and 2020. The 3-year OS was assessed using landmark analysis. Independent risk factors associated with 3-year OS were identified using a Cox proportional hazards regression model.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
September 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fujian Medical University
Responsible Party
Principal Investigator
Principal Investigator

Chang-Ming Huang, Prof.

Fujian Medical University Union Hospital

Fujian Medical University

Eligibility Criteria

Inclusion Criteria

  • (1) preoperative neoadjuvant chemotherapy; (2) primary gastric adenocarcinoma, diagnosed by gastroscopic pathology findings before neoadjuvant chemotherapy in complete pathological remission (pCR) cases or via postoperative pathology findings in all other instances; (3) absence of distant metastases in the liver, lungs, or abdominal cavity, as confirmed by preoperative chest radiography or chest computed tomography (CT), abdominal ultrasonography, abdominal CT, and other imaging; (4) radical gastric cancer surgery (R0) and D2 lymph node dissection; and (5) postoperative pathologic verification of no lymph node metastasis (i.e., lymph node-negative).

Exclusion Criteria

  • (1) preoperative radiotherapy or radiochemotherapy, (2) discovery of distant metastases preoperatively or intraoperatively, (3) coexistence of other malignant tumors, (4) residual gastric cancer, and (5) perioperative patient mortality.

Outcomes

Primary Outcomes

3-year overall survival

Time Frame: 3 years

3-year overall survival

Study Sites (1)

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