OncoMatch/Clinical Trials/NCT03941561
S-1 for 9 Months Versus 1 Year for Stage II Gastric Cancer (SMAC）
Is NCT03941561 recruiting? Yes, currently enrolling (May 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
Cancer type
Gastric Cancer
Disease stage
Required: Stage II
Excluded: Stage I, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
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.
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