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Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Minor Enrollment closed, study ongoing
    • Primary completion date changed from estimate of May 31, 2026 to Aug 10, 2026
    • Site details revised at 5 of 5 sites
    • Collaborators: 3 to 4
    v6
  2. Minor Study sites: 4 to 5
    • Primary completion date: Mar 1, 2026 to May 31, 2026
    v5
  3. Notable Primary completion date: Sep 1, 2025 to Mar 1, 2026
    • Study sites: 1 to 4
    • Study completion date: Sep 30, 2025 to Sep 30, 2026
    • Collaborators expanded, about 14 words
    v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 1, 2024 to Nov 15, 2024
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
179 trials monitored
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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.
Trial Details
NCT Number NCT06576921
Lead Sponsor Xijing Hospital
Collaborators: Tang-Du Hospital, Hebei Medical University Fourth Hospital, Tianjin Medical University Cancer Institute and Hospital, The 986th Military Hospital
Conditions
(from sponsor)
Stomach Neoplasms, Immune Checkpoint Inhibitors
Related terms Stomach Neoplasms
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov