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Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)

StatusRecruiting
PhasePhase 2
SponsorYu jiren
Started2023-12-24
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 17, 2024 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2024-01-15
Study Status v3
Start dateestimated 2023-12-15→confirmed 2023-12-24
2023-12-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2023-09-15→2023-12-15
Study sitesdetails revised at 5 of 5 sites
2023-08-05
Study Status v1
Start date2023-06-15→2023-09-15
2023-05-23
Original filing
Yu jiren
5 trials monitored
See all monitored trials
Gastric Cancer
1,194 trials monitored
See 60 trials at risk
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
Trial Details
NCT Number NCT05872685
Lead Sponsor Yu jiren
Conditions Adenocarcinoma of the Stomach, Adenocarcinoma of Esophagogastric Junction, Proficient Mismatch Repair
Enrollment 314 participants
Start Date 2023-12-24
Primary Completion 2026-04-30 (estimated)
Study Completion 2029-04-30 (estimated)
Updated on ClinicalTrials.gov 2024-01-17