OncoMatch/Clinical Trials/NCT06576921
Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction
Is NCT06576921 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Serplulimab Combined With Chemotherapy for stomach neoplasms.
Treatment: Serplulimab Combined With Chemotherapy — This is a multicenter, double-blind, randomized, phase 2 trial to investigate the efficacy and safety of serlulimab combined with nab-paclitaxel plus SOX versus nab-paclitaxel plus SOX alone as neoadjuvant treatment for locally advanced GC or AEG. The goal of this clinical trial is to learn if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC. It will also learn about the safety of serlulimab combined with nab-paclitaxel plus SOX. The main questions it aims to answer are: Does serlulimab increase the pCR of participants with locally advanced AEG/GC ? What medical problems do participants have when taking serlulimab? Researchers will compare to a placebo (a look-alike substance that contains no drug) to see if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC. Participants will: Eligible patients were randomly assigned to receive serlulimab (4.5 mg intravenously on day 1) combined with chemotherapy (nap-paclitaxel 260 mg/m2 intravenously on days 1, OXA 130mg/ /m2, intravenously on days 1, and S-1 40 to 60 mg orally twice daily depending on BSA on days 1 to 14) or chemotherapy alone every 3 weeks for 3 preoperative cycles followed by 3 postoperative cycles. All patients will be followed for survival.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Excluded: HER2 (ERBB2) overexpression or amplification
Positive Her-2 detection (IHC3+ or IHC2+ amplified by FISH detection)
Disease stage
Required: Stage T4N+M0
Clinical stage T3/T4N+M0 disease as assessed by CT/MRI, PET-CT, and laparoscopy, if feasible
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Cannot have received: radiotherapy
Cannot have received: hormone therapy
Cannot have received: targeted therapy
Cannot have received: immunotherapy
Lab requirements
Blood counts
white blood cell count ≥3.5 ×10^9/L, neutrophils ≥1.5 × 10^9/L, platelet count >100 × 10^9/L, and hemoglobin ≥90 g/L
Kidney function
serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr) ≥60mL/min
Liver function
ALT and AST ≤2.5×ULN; total bilirubin (TBIL) ≤1.5×ULN (Gilbert syndrome patients, ≤3×ULN)
Acceptable bone marrow, hepatic, and renal function, including: ... see full text
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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