RecruitingPhase 3NCT03941561

S-1 for 9 Months Versus 1 Year for Stage II Gastric Cancer (SMAC）

Compare S-1 for 9 Months to 1 Year as Adjuvant Chemotherapy in Stage II Gastric Cancer (SMAC）

Sponsor

Fudan University

Enrollment

1,006 participants

Start Date

Jan 1, 2019

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

The lower age limit of research subjects 18 years old and upper age limit of 75 years old.
Be proven to be primary adenocarcinoma of gastric cancer and staged II by pathological evidence
R0 surgery with lymphadenectomy
Without any other malignancies
ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
No contraindications to chemotherapy, including normal peripheral blood routine, liver, and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L, PLT≥100 x 109 /L and HGB≥90g/L).

Exclusion Criteria9

Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy.
Patients with stage I, III and IV.
Unavailable for R0 resection and D2 lymph node dissection.
Suffering from other uncontrolled diseases, such as other tumors, acute and Chronic infection.
With severe heart disease, including congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe heart valve disease, and resistant hypertension.
Any Known or suspected history of drug allergy test.
The researchers believe the patient is not able to complete the entire course of the experiment.
Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy, biological therapy, radiation therapy, or Immunosuppressive therapy.
Patients conform to any of the following: post-organ transplant, necessary for long-term immunosuppressive or suffering with autoimmune diseases.