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.
Age older than 18 and younger than 75 years
Primary GC or AEG (Siewert II/III)confirmed pathologically by endoscopic biopsy
Clinical stage T3/T4N+M0 disease as assessed by CT/MRI, PET-CT, and laparoscopy, if feasible
At least one measurable lesion according to the RECIST, version 1.1
Squamous cell carcinoma, adenosquamous cell carcinoma, small cell carcinoma, and undifferentiated gastric cancer were confirmed by pathology
Positive Her-2 detection (IHC3+ or IHC2+ amplified by FISH detection)
Prior chemotherapy, radiotherapy, hormone therapy, targeted therapy, or immunotherapy
Contraindications for surgical treatment or chemotherapy
Parallel
Serplulimab Combined With Chemotherapy
DrugSerplulimab (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
DrugPlacebo (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.
Pathological complete response rate (pCR)
postoperative pathological response according to the Mandard tumor regression grading system (TRG), TRG 1 is pCR.
R0 resection rate
The tumor was completely removed during the operation, and the cutting edge was also negative when viewed under the microscope, that is, the resection effect was perfect and there were no residual components of the tumor
1 year Progression-free survival rate (PFS)
From the beginning of treatment, patients are able to survive for one year with no probability of disease recurrence.
Adverse event (AE)
Safety of study drugs according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Morbidity
Discomfort, dysfunction and other problems caused by surgical injury
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Xijing Hospital
Lead sponsor
Tang-Du Hospital
Collaborator
Hebei Medical University Fourth Hospital
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
