Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction
NCT Number: NCT06576921
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Stomach Neoplasms|Immune Checkpoint Inhibitors
Interventions: DRUG: Serplulimab Combined With Chemotherapy|DRUG: Placebo combined with Chemotherapy
Sponsor: Xijing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-30

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.

Primary Outcome Measures: Pathological complete response rate (pCR), postoperative pathological response according to the Mandard tumor regression grading system (TRG), TRG 1 is pCR., 3 weeks after completion of the neoadjuvant treatment phase
Secondary Outcome Measures: 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, 30 days after completion of the surgery phase|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., 1 year|Adverse event (AE), Safety of study drugs according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, 90 days after completion of treatment|Morbidity, Discomfort, dysfunction and other problems caused by surgical injury, 30 days after completion of the surgery phase|Mortality, Proportion of total deaths among all patients undergoing surgery based on observational follow-up (whether cause of death is causally related to surgery or not), 30 days after completion of the surgery phase|Hospital stay, From the first day after surgery to the day before discharge, 90 days after completion of the surgery phase|Overall survival, From randomization to the time of death from any cause., 3 years|Disease-free survival, The time from the start of randomization until disease recurrences or patients die due to disease progression, 3 years