Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer

• Status: Recruiting
• Trial end date: 2024-02-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Cancer Hospital
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• sign written informed consent form

• age ≥ 18 years, ≤69 years

• ECOG status: 0~2

• pathologically confirmed gastric cancer at stage II or IIIA (AJCC 7th version)

• negative peritoneal cytology

• underwent curative distal gastrectomy with D2 lymph node dissection

• no prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy

• adequate organ function as defined below: Hematologic ANC ≥ 2*109/L, Platelets ≥ 100*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.

Exclusion Criteria:

• be enrolled in other clinical trials

• underwent prior antitumor treatment

• allergic reaction to S-1 or oxaliplatin

• abnormal GI tract function

• female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy

• other situation to be judged not adaptive to the study by investigators