NCT07507916

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

Dynamic Circulating Tumor DNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma：A Phase 2 Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, prospective, exploratory study designed to evaluate the feasibility and clinical value of using dynamic circulating tumor DNA (ctDNA) testing to guide postoperative adjuvant treatment in patients with stage III or stage IVA gastric or gastroesophageal junction adenocarcinoma. After curative-intent surgery, patients remain at risk of disease recurrence. Currently, postoperative adjuvant treatment decisions are mainly based on clinical and pathological factors, which may not fully reflect the presence of minimal residual disease. ctDNA is a blood-based biomarker that can detect small amounts of tumor-derived DNA and may provide additional information about recurrence risk after surgery. In this study, ctDNA will be dynamically assessed at predefined perioperative and postoperative time points using peripheral blood samples. The study aims to explore the association between postoperative ctDNA status and disease outcomes, as well as the potential role of ctDNA monitoring in postoperative adjuvant treatment management. The primary objective of this study is to evaluate disease-free survival at 1 year. Secondary objectives include assessment of survival outcomes, safety, and changes in ctDNA status over time. The results of this exploratory study are expected to provide preliminary evidence to support further clinical research on ctDNA-guided adjuvant treatment strategies in gastric cancer.

Conditions

• ctDNA
• Gastric Cancer
• Gastroesophageal Junction (GEJ) Adenocarcinoma
• Adjuvant Treatment

Interventions

Type	Name	Description
DRUG	HLX10	HLX10 is a programmed death-1 (PD-1) monoclonal antibody administered as postoperative adjuvant treatment
DRUG	SOX Chemotherapy	SOX chemotherapy consists of S-1 in combination with oxaliplatin and is administered as part of postoperative adjuvant treatment

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2026-04-02
• Last updated: 2026-04-02