Actively Recruiting
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
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-03-16
124
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years.
- Underwent radical surgery with D2 or wider lymph node dissection and achieved R0 resection.
- No prior systemic anti-tumor treatment before surgery.
- Histopathologically confirmed gastric adenocarcinoma.
- Pathological stage III gastric or gastroesophageal junction adenocarcinoma.
- HER2 moderate-to-high expression (IHC 3+ or 2+).
- ECOG Performance Status of 0 or 1.
- Expected survival time of at least 3 months.
- Able to understand the study and provide informed consent.
- Good compliance and able to follow the treatment plan.
- Complete imaging and pathological clinical data available.
- Adequate organ and bone marrow function.
You will not qualify if you...
- Primary stage III gastric or gastroesophageal-junction adenocarcinoma not confirmed by pathology or cytology.
- Unable to receive disitamab vedotin or SOX chemotherapy.
- Unable to follow the required follow-up schedule.
- Unable to accept the treatment plan specified in this study.
- Unable or unwilling to undergo required response assessments like CT scans.
- Active autoimmune disease.
- History of substance abuse that cannot be stopped, or severe/uncontrolled psychiatric or systemic disease.
- Any condition posing significant risk or compromising study completion as judged by the investigator.
- Other cancers within 5 years before screening, except certain treated and cured cancers.
- Lactating women.
- Prior neoadjuvant therapy or intraperitoneal chemotherapy during surgery.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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