RecruitingPhase 2NCT07474324

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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

124 participants

Start Date

Mar 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding a targeted antibody-drug treatment (disitamab vedotin, which delivers chemotherapy directly to cancer cells) to a standard chemotherapy regimen (SOX) improves outcomes for people who had surgery for stage III stomach cancer that has a higher level of the HER2 protein. **You may be eligible if...** - You are between 18 and 75 years old - You had surgery to remove your stomach cancer (radical resection with complete tumor removal — R0) - Your cancer was confirmed to be stage III stomach or gastroesophageal junction adenocarcinoma - Your tumor has moderate to high HER2 expression (IHC 2+ or 3+) - You did not receive chemotherapy or any other treatment before surgery - You are in good general health (ECOG 0 or 1) **You may NOT be eligible if...** - You received treatment before surgery (neoadjuvant therapy) - You have an active autoimmune disease - You have another cancer diagnosed in the last 5 years (with some exceptions) - You are breastfeeding - You have a serious psychiatric illness or uncontrolled systemic disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRC48

RC48 2.5mg/kg iv. ,q3w

DRUGSOX Chemotherapy

S-1: 40-60 mg/m², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 100 mg/m², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.

DRUGSOX(normal)

S-1: 40 mg/m², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 130 mg/m², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.


Locations(1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

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NCT07474324


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