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

NCT07507916 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2029-12-31
Completion
2029-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507916 on ClinicalTrials.gov