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ctDNA-MRD Monitoring After Neoadjuvant Therapy in Gastric Cancer With pCR or MPR

NCT07799649 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-09-02

No results posted yet for this study

Summary

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.

Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Interventions

DIAGNOSTIC_TEST

Tumor-Informed ctDNA-MRD Monitoring

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.

OTHER

Clinician-Selected Standard-of-Care Postoperative Treatment

Postoperative treatment is selected by treating clinicians according to guidelines and individual clinical factors. The study does not assign, randomize, or modify treatment.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Hao Xu · The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2032-04-30
Completion
2032-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07799649 on ClinicalTrials.gov