Not Yet RecruitingPhase 2

Dynamic ctDNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma

32 participantsStarted 2026-04-01

Plain-language summary

This is a single-center, prospective, exploratory study evaluating the use of dynamic circulating tumor DNA (ctDNA) monitoring in the postoperative adjuvant treatment setting for patients with stage III or stage IVA gastric or gastroesophageal junction adenocarcinoma. After curative-intent surgery, patients remain at risk of disease recurrence. Postoperative treatment decisions are currently based on clinicopathological factors, which may not fully reflect minimal residual disease. ctDNA is a blood-based biomarker that can detect tumor-derived DNA fragments and may provide additional information on recurrence risk. In this study, ctDNA will be assessed at predefined perioperative and postoperative time points using peripheral blood samples. The primary objective is to evaluate 1-year disease-free survival. Secondary objectives include survival outcomes, safety, and longitudinal changes in ctDNA status. The findings of this exploratory study may inform future research on ctDNA-guided postoperative management in gastric cancer.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Voluntarily participate in the study; fully understand the study and sign the written informed consent form (ICF); be willing and able to comply with all study procedures.
✓. Male or female patients aged ≥18 years and ≤75 years at the time of signing the ICF.
✓. Histologically confirmed, previously untreated gastric cancer or gastroesophageal junction (GEJ) cancer, with adenocarcinoma as the predominant histology. For GEJ cancer, only Siewert type III and Siewert type II tumors not requiring thoracotomy are eligible.
✓. Clinically confirmed stage III or stage IVA disease without distant metastasis, as assessed by the treating physician prior to enrollment.
✓. HER2-negative disease.
✓. Adequate cardiac function and deemed suitable for curative-intent surgical resection. Patients with ischemic heart disease, valvular disease, or other significant cardiac conditions should undergo preoperative evaluation by a cardiologist if clinically indicated.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to enrollment.
✓. Estimated life expectancy of at least 6 months.

Exclusion criteria

What they're measuring

1 year Disease-Free Survival rate

Timeframe: Up to 1 year after surgery

Trial details

NCT IDNCT07507916

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

Jun Lu

18916871096 lujun@fudan.edu.cn

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