Actively Recruiting
Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage IIIGastric 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary effectiveness and safety of combining disitamab vedotin with the SOX chemotherapy regimen compared to SOX alone. This phase II, prospective, multicenter, randomized clinical trial focuses on patients with HER2-moderate to high-expressing stage III gastric or gastroesophageal junction adenocarcinoma who have undergone D2 or more extensive surgery with no prior systemic anti-tumor treatment before surgery. Participants will receive adjuvant therapy starting about four weeks after surgery, with one group treated with disitamab vedotin plus SOX and the other with SOX alone. Treatment consists of 6 to 8 cycles. Post-operative imaging assessments occur every three months to monitor for disease recurrence. Following any recurrence, survival follow-up visits are conducted every three months. Safety visits continue from the first dose until 60 days after the last dose or until a new anti-tumor treatment begins. During the study, participants will undergo regular imaging to assess disease status, and researchers will monitor safety and survival outcomes. The primary outcome is the 3-year disease-free survival rate, with secondary measures including overall survival rates and adverse event incidence over several years. Participants can expect ongoing follow-up for up to five years after treatment to evaluate long-term outcomes.
CONDITIONS
Brief 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 written 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...
- Gastric or gastroesophageal junction adenocarcinoma not confirmed by histology or cytology.
- Unable to receive disitamab vedotin or SOX chemotherapy.
- Unable to comply with follow-up schedule.
- Unable to accept the specified treatment regimen.
- Unwilling or unable to undergo required response assessments like CT imaging.
- Active autoimmune disease.
- History of substance abuse or severe/uncontrolled psychiatric or systemic disease.
- Any condition posing significant risk or compromising study completion.
- Other malignancies within 5 years except certain treated cancers considered cured.
- Lactating women.
- Prior neoadjuvant therapy or intra-operative intraperitoneal chemotherapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 to 6 months
Participants receive adjuvant therapy with disitamab vedotin combined with SOX chemotherapy or SOX chemotherapy alone for 6 to 8 cycles.
6 to 8 treatment cycles, each lasting about 3 weeks
Duration - Up to 3 years or until disease recurrence
Participants undergo imaging assessments every three months until disease recurrence to monitor their condition.
Imaging visits every 3 months
Duration - Until study completion or death
After disease recurrence, participants are followed every three months to monitor survival and overall health.
Visits every 3 months
Duration - From first dose until 60 days post last dose or new therapy initiation
Safety visits occur from the first drug administration until 60 days after the last dose or until starting new anti-tumor therapy to monitor adverse events.
Regular safety visits during and shortly after treatment
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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