Y U several terms
Y U several terms
This phase II study is a prospective, multi-center, double-blinded, and randomized trial to compare the efficacy and safety of perioperative SOX plus serplulimab with SOX plus placebo for locally advanced gastric adenocarcinoma with proficient mismatch repair
Adenocarcinoma of the Stomach
Adenocarcinoma of Esophagogastric Junction
Proficient Mismatch Repair
S1
Oxaliplatin
serplulimab
Placebo
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 314 participants |
Masking : | Quadruple |
Primary Purpose : | Treatment |
Official Title : | Perioperative S-1 Plus Oxaliplatin Combined With Serplulimab or Placebo for Locally Advanced Gastric Adenocarcinoma With Proficient Mismatch Repair: a Prospective, Multi-center, Double-blinded, Randomized Placebo-controlled Study |
Actual Study Start Date : | December 24, 2023 |
Estimated Primary Completion Date : | April 30, 2026 |
Estimated Study Completion Date : | April 30, 2029 |
Arm | Intervention/treatment |
---|---|
Experimental: Group A (Chemotherapy+Serplulimab ) Drug: Oxaliplatin,S-1,Serplulimab Chemotherapy (SOX): Oxaliplatin, administered as a 2-hour intravenous infusion (130 mg/m2) S-1, orally twice daily for 2 weeks followed by a 7-day rest period. The dose of S-1 was 80 mg/day for body surface area less than 1.25 m2, 100 mg/day for body surface area greater than or equal to 1.25 to less than 1.5 m2, and 120 mg/day for body surface area greater than or equal to 1.5 m2 Chemotherapy will be repeated each 21 day for 3 cycles prior to surgery and 3 cycles after surgery. Serplulimab: 300 mg IV infusion on Day 1 of each 21 day cycle for 3 cycles prior to surgery and 3 cycles after surgery. |
Drug: S1 Drug: Oxaliplatin Drug: Serplulimab |
Active Comparator: Group B (Chemotherapy+Placebo ) Drug: Oxaliplatin,S-1,Placebo Chemotherapy (SOX): Oxaliplatin, administered as a 2-hour intravenous infusion (130 mg/m2) S-1, orally twice daily for 2 weeks followed by a 7-day rest period. The dose of S-1 was 80 mg/day for body surface area less than 1.25 m2, 100 mg/day for body surface area greater than or equal to 1.25 to less than 1.5 m2, and 120 mg/day for body surface area greater than or equal to 1.5 m2 Chemotherapy will be repeated each 21 day for 3 cycles prior to surgery and 3 cycles after surgery. Placebo: 300 mg IV infusion on Day 1 of each 21 day cycle for 3 cycles prior to surgery and 3 cycles after surgery. |
Drug: S1 Drug: Oxaliplatin Drug: Placebo |
Ages Eligible for Study: | 18 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Not yet recruiting
The Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Not yet recruiting
Lishui Central Hospital
l Who, Zhejiang, China, 323000
Not yet recruiting
Ningbo Medical Center LiHuiLi Hospital
Ningbo, Zhejiang, China, 315048
Not yet recruiting
Taizhou Hospital
Taizhou, Zhejiang, China, 317099