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.
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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Age 18 to 75 years.
* Histologically confirmed gastric or gastroesophageal junction adenocarcinoma.
* Completion of preoperative neoadjuvant therapy followed by R0 gastrectomy.
* Postoperative pathological complete response, defined as Becker tumor regression grade 1a or Ryan tumor regression grade 0, or major pathological response, defined as Becker tumor regression grade 1b or Ryan tumor regression grade 1 with 10 percent or less residual viable tumor.
* Willingness to undergo serial blood collection and follow-up and provision of written informed consent.
* Eastern Cooperative Oncology Group performance status of 0 or 1 with adequate major organ function.
* Adequate diagnostic biopsy or preoperative tumor tissue for 1021-gene panel testing.
Exclusion Criteria:
* Postoperative pathological assessment showing neither pathological complete response nor major pathological response, including more than 10 percent residual viable tumor or Becker tumor regression grade 2 to 3.
* Distant metastatic disease identified intraoperatively or postoperatively.
* Another malignant tumor within the previous 5 years.
* Severe postoperative complications preventing any postoperative antitumor therapy.
* Contraindication to immunotherapy, including active autoimmune disease.
Primary outcome measure(s)
Three-Year Disease-Free Survival Rate — From R0 gastrectomy through 3 years after surgery 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.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Nanjing
Jiangsu
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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