Comparison of With and Without Sequential Single Drug Therapy of S-1 After Adjuvant Chemotherapy With Docetaxel Plus S-1 in Stage III Gastric Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The goal of this single arm clinical trial is to learn about sequential S-1 adjuvant therapy in patient wich locally advanced gastric cancer. The main question it aims to answer is: • The efficacy and safety of S-1 adjuvant therapy, following D2 radical surgery and DS(Docetaxel + S-1) adjuvant chemotherapy. All patients with locally advanced gastric cancer will received D2 radical surgery, 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy up to 1 year postoperation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• (1) Histologically or cytologically confirmed adenocarcinoma of the stomach or adenocarcinoma of the gastroesophageal junction;

• (2) Radical surgery (D2 lymph node dissection) for gastric cancer in our center, with postoperative pathological stage of stage III;

• (3) No significant tumor recurrence or metastasis as assessed by imaging;

• (4) Age 18 years - 75 years;

• (5) ECOG score of 0 or 1;

• (6) Laboratory tests tolerant to chemotherapy;

• (7) Hematological examination: no obvious signs of hematologic diseases, ANC ≥ 1.5 × 10\^9/L, platelet count ≥ 80 × 10\^9/L, Hb ≥ 90 g/L, WBC ≥ 3.0 × 10\^9/L before enrollment, and no bleeding tendency; (8) Biochemical examination: total bilirubin \< 1.5 times the upper limit of normal value, AST, ALT \< 2.5 times the upper limit of normal value, creatinine \< 1.5 times the upper limit of normal value.

Locations
Other Locations
China
Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
RECRUITING
Hanzhou
Contact Information
Primary
Xiaoli Jin
Jinxiaoli@zju.edu.cn
+86-13605809870
Time Frame
Start Date: 2023-01-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 70
Treatments
Experimental: DS-S group
All patients pathologically confirmed pTNM stage III, will receive 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy till 1 year postoperation.
Related Therapeutic Areas
Sponsors
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov

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