Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage Ⅲ Gastric Cancer: A Prospective, Multicenter, Randomized, Phase Ⅱ Clinical Trial

Recruiting Phase 2 Interventional Study
GC/GEJC
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
124 (estimated)
Sponsor
The First Affiliated Hospital with Nanjing Medical University · Other
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About This Trial

This is a prospective, multicenter, randomized, phase II clinical trial intended to enroll patients with HER2-moderate/high-expressing, pathologically staged stage III gastric cancer who have undergone D2 or more extensive surgery. The study aims to evaluate the preliminary efficacy and safety of disitamab vedotin combined with the SOX regimen versus SOX alone as post-operative adjuvant therapy.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Aged between 18 and 75 years. * Have undergone radical resection with D2 or wider lymph node dissection and achieved R0 resection status. * No prior systemic anti-tumor treatment (i.e., neoadjuvant therapy) before surgery. * Histopathologically confirmed gastric adenocarcinoma…
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