A Prospective, Single-Center Observational Study Evaluating Recurrence Risk Using ctDNA-Based Molecular Residual Disease Monitoring in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma Achieving Pathological Complete Response or Major Pathological Response After Neoadjuvant Therapy
Sponsor study identifier
observational
150
1 country
1
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This prospective observational study will enroll adults with gastric or gastroesophageal junction adenocarcinoma who achieve pathological complete response or major pathological response after neoadjuvant therapy and R0 gastrectomy. The study will evaluate whether postoperative circulating tumor DNA-based molecular residual disease status can identify participants at increased risk of recurrence despite a favorable pathological response. All postoperative treatment decisions will be made by the treating clinicians according to routine care and will not be assigned by the study. Tumor-informed ctDNA-MRD testing will be performed longitudinally, and results will not be used to alter treatment. Participants will be followed for disease-free survival, overall survival, recurrence detection, and adverse events.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2026
Actual (reported)September 2, 2026
Actual (reported)April 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Three-Year Disease-Free Survival Rate
Disease-free survival is defined as the time from R0 gastrectomy to the first documented tumor recurrence or death from any cause, whichever occurs first. Participants without an event will be censored at the last disease assessment. The 3-year disease-free survival rate will be estimated using the Kaplan-Meier method.
From R0 gastrectomy through 3 years after surgery
Three-Year Overall Survival Rate
From R0 gastrectomy through 3 years after surgery
Lead Time From ctDNA-MRD Detection to Radiographic Recurrence
From the first postoperative ctDNA-MRD assessment through 3 years after surgery
Sensitivity and Specificity of ctDNA-MRD for Postoperative Recurrence
From the first postoperative ctDNA-MRD assessment through 3 years after surgery
Three-Year Disease-Free Survival by Postoperative Adjuvant Treatment Strategy
From R0 gastrectomy through 3 years after surgery
Incidence of Adverse Events
From enrollment through 3 years after surgery
Participants with gastric or gastroesophageal junction adenocarcinoma who achieve pathological complete response or major pathological response after neoadjuvant therapy and R0 gastrectomy. All participants undergo longitudinal ctDNA-MRD monitoring and receive clinician-selected standard-of-care postoperative management.
Patient-specific somatic variants identified from tumor tissue are used to construct an individualized panel for ultra-deep sequencing of plasma cell-free DNA at prespecified perioperative and follow-up time points. Results are used for observational correlation and do not guide treatment changes.
Adults treated at The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital) with histologically confirmed gastric or gastroesophageal junction adenocarcinoma who have completed neoadjuvant therapy, undergone R0 gastrectomy, and achieved pathological complete response or major pathological response.
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Nanjing, Jiangsu, 210029, China
Hao Xu
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
First Submitted
September 1, 2026
First Posted
September 2, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2032
Postoperative treatment is selected by treating clinicians according to guidelines and individual clinical factors. The study does not assign, randomize, or modify treatment.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 2, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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