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

ConditionGC/GEJC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Primary stage III gastric or gastroesophageal-junction adenocarcinoma not histologically or cytologically confirmed;

Unable to receive disitamab vedotin or SOX chemotherapy;

Unable to comply with the required follow-up schedule;

Unable to accept the treatment regimen specified in this protocol;

Trial design

Treatments tested in this trial

  • RC48
  • SOX Chemotherapy
  • SOX(normal)

Treatment groups

124 Participants
are divided into 2 treatment groups