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.
After providing informed consent and meeting all eligibility criteria, participants will begin adjuvant therapy with disitamab vedotin plus chemotherapy (SOX) approximately four weeks after surgery, continuing for 6-8 cycles. Post-operative imaging assessments will be performed every three months until disease recurrence. Following recurrence, survival follow-up will be conducted every three months. Safety visits will continue from first drug administration until 60 days after the last dose or until initiation of new anti-tumor therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
RC48 2.5mg/kg iv. ,q3w
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.
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.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITING3-year-DFS rate
The 3-year disease-free survival (DFS) rate is defined as the proportion of participants who remain free of any of the following events for at least three years from the date of randomization: tumor recurrence, new primary tumor, or death from any cause. Patients who undergo curative-intent surgery and experience none of these events are considered disease-free.
Time frame: 3 years
Disease-Free Survival (DFS)
Defined from the date of completion of curative-intent treatment (e.g., surgery, adjuvant chemotherapy) to the date of first documentation of disease recurrence (e.g., tumor relapse, metastasis) or death from any cause, whichever occurs first.
Time frame: 3 years
2-year-OS rate
The 2-year overall survival (OS) rate is defined as the proportion of participants who remain alive for at least two years from the date of randomization, regardless of whether disease recurrence or progression has occurred.
Time frame: 2 years
3-year OS rate
The 3-year overall survival (OS) rate is defined as the proportion of participants who remain alive for at least two years from the date of randomization, regardless of whether disease recurrence or progression has occurred.
Time frame: 3 years
Overall Survival (OS)
Defined from date of recruit to date of first documentation of death from any cause or censored at the date of the last follow-up.
Time frame: 5 years
Incidence rate of adverse events (AEs)
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0
Time frame: 3 years
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