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

Sponsor
Fudan University
Study ID
NCT07507916
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Apr 2, 2026
Start date
Apr 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ctDNA-Positive（after surgery）
    Patients with detectable circulating tumor DNA (ctDNA) after surgery will receive adjuvant treatment with HLX10 in combination with SOX chemotherapy
  • Experimental: ctDNA-Negative（after surgery）
    Patients without detectable circulating tumor DNA (ctDNA) after surgery will receive adjuvant treatment with HLX10 monotherapy

Primary Outcome Measure

1 year Disease-Free Survival rate [ Time Frame: Up to 1 year after surgery ]

Central Contacts

Find similar trials

Nationwide
Gastric cancer trialsOncology trialsGI oncology trials

Related Studies