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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
Sponsor: Xijing Hospital
Summary
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.
Official title: Efficacy and Safety of Serplulimab Combined With Nab-paclitaxel and SOX as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2024-11-15
Completion Date
2026-09-30
Last Updated
2025-12-23
Healthy Volunteers
No
Interventions
Serplulimab Combined With Chemotherapy
Serplulimab (Dosage form: Lyophilized powder; Unit dose strength: 4.5 mg; Route of administration: IV infusion; Storage requirements: 2-8℃. Protect from light and freezing.) Nap-paclitaxel (Dosage form: Lyophilized powder; Unit dose strength: 100 mg; Route of administration: IV infusion; Storage requirements: \<25℃. Protect from light.) S-1 (Dosage form: Capsule; Unit dose strength: 20 mg; Route of administration: Oral; Storage requirements: 20-30℃. Protect from light.) Oxaliplatin (Dosage form: Lyophilized powder; Unit dose strength: 50 mg; Route of administration: IV infusion; Storage requirements: \<25℃. Protect from light.) Surgery: All surgical procedures are performed according to the guidelines of the Japanese Research Society for the Study of Gastric Cancer.
Placebo combined with Chemotherapy
Placebo (Dosage form: Lyophilized powder; Unit dose strength: 4.5 mg; Route of administration: IV infusion; Storage requirements: 2-8℃. Protect from light and freezing.) Nap-paclitaxel (Dosage form: Lyophilized powder; Unit dose strength: 100 mg; Route of administration: IV infusion; Storage requirements: \<25℃. Protect from light.) S-1 (Dosage form: Capsule; Unit dose strength: 20 mg; Route of administration: Oral; Storage requirements: 20-30℃. Protect from light.) Oxaliplatin (Dosage form: Lyophilized powder; Unit dose strength: 50 mg; Route of administration: IV infusion; Storage requirements: \<25℃. Protect from light.) Surgery: All surgical procedures are performed according to the guidelines of the Japanese Research Society for the Study of Gastric Cancer.
Locations (4)
The fourth hospital of Hebei Medical University
Shijiazhuang, Heibei Province, China
Department of Digestive surgery, Xijing Hospital of Digestive Diseases, Air Force Medical University, Xi' an, China
Xi'an, Shaanxi, China
Department of General Surgery, Tangdu Hospital, Air Force Medical University
Xi'an, Shaanxi, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China