Condition: Stomach Neoplasms · Immune Checkpoint Inhibitors · Sponsor: Xijing Hospital
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.
This description comes directly from the study's public registry record.
Zhenshun Li, Ph.D · 15922893108 · 769054503@qq.com
Always discuss trial participation with your own doctor first.
| The fourth hospital of Hebei Medical University | Shijiazhuang, Heibei Province, China | Recruiting |
| Department of Digestive surgery, Xijing Hospital of Digestive Diseases, Air Force Medical University, Xi' an, China | Xi'an, Shaanxi, China | Recruiting |
| Department of General Surgery, Tangdu Hospital, Air Force Medical University | Xi'an, Shaanxi, China | Recruiting |
| Department of General Surgery, The 986th Military Hospital, Air Force Medical University | Xi'an, Shaanxi, China | Recruiting |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06576921