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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT07799649
Status
Not Yet Recruiting

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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tumor-Informed ctDNA-MRD Monitoring — DIAGNOSTIC_TEST
    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.
  • Clinician-Selected Standard-of-Care Postoperative Treatment — OTHER
    Postoperative treatment is selected by treating clinicians according to guidelines and individual clinical factors. The study does not assign, randomize, or modify treatment.

Study Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Apr 30, 2032
Completion
Apr 30, 2032

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Prospective pCR/MPR Cohort
    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.

Primary Outcome Measure

Three-Year Disease-Free Survival Rate [ Time Frame: From R0 gastrectomy through 3 years after surgery ]

Central Contacts

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