NCT07799649Not yet recruiting
ctDNA-MRD Monitoring After Neoadjuvant Therapy in Gastric Cancer With pCR or MPR
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
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Apr 2032
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07799649
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Sept 2026 to the primary completion date, 30 Apr 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Another malignant tumor within the previous 5 years.
- Severe postoperative complications preventing any postoperative antitumor therapy.
Other illness
- Distant metastatic disease identified intraoperatively or postoperatively.
- Contraindication to immunotherapy, including active autoimmune disease.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital) Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.