OncoMatch/Clinical Trials/NCT03941561
S-1 for 9 Months Versus 1 Year for Stage II Gastric Cancer (SMAC）
Is NCT03941561 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including S-1 for 9 months and S-1 for 1 year for gastric cancer.
Treatment: S-1 for 9 months · S-1 for 1 year — The study aims to compare the efficacy and safety of S-1 for 9 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer. Hypothesis: For gastric patients after D2 resection, S-1 for 9 months shows non-inferiority to S-1 for 1 year in disease-free survival(DFS), overall survival (OS) and safety.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Gastric Cancer
Disease stage
Required: Stage II
Excluded: Stage I, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: R0 surgery with lymphadenectomy
R0 surgery with lymphadenectomy
Cannot have received: anti-cancer drugs therapy
Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy
Cannot have received: biological therapy
Patients (within 4 weeks) are receiving...biological therapy
Cannot have received: radiation therapy
Patients (within 4 weeks) are receiving...radiation therapy
Cannot have received: immunosuppressive therapy
Patients (within 4 weeks) are receiving...Immunosuppressive therapy
Lab requirements
Blood counts
WBC≥4.0 x 10^9 /L, NEU≥1.5 x 10^9 /L, PLT≥100 x 10^9 /L and HGB≥90g/L
Kidney function
normal kidney function
Liver function
normal liver function
Cardiac function
electrocardiogram normal; severe heart disease excluded
No contraindications to chemotherapy, including normal peripheral blood routine, liver, and kidney function and electrocardiogram （WBC≥4.0 x 10^9 /L, NEU≥1.5 x 10^9 /L, PLT≥100 x 10^9 /L and HGB≥90g/L). With severe heart disease, including congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe heart valve disease, and resistant hypertension [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT03941561 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-cancer drugs therapy, biological therapy, radiation therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage II is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages