A Randomized Controlled Study of Serplulimab Combined With Chemotherapy for Locally Advanced Gast… (NCT07257575) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Randomized Controlled Study of Serplulimab Combined With Chemotherapy for Locally Advanced Gastric Adenocarcinoma
China138 participantsStarted 2025-01-05
Plain-language summary
The goal of this clinical trial is to learn if FLOT chemotherapy combined with serplulimab can improve the pathological complete response (pCR) rate in patients with stage III gastric cancer. The main question it aims to answer is:
Can FLOT chemotherapy combined with serplulimab improve the pathological complete response (pCR) rate in patients with stage III gastric cancer? Researchers will compare serplulimab with a blank control group to see if it can improve the pathological complete response (pCR) rate in patients with stage III gastric cancer.
Participants will :
Receive serplulimab combined with FLOT chemotherapy or FLOT chemotherapy alone every 2 weeks Undergo imaging assessments at 4 weeks and 8 weeks Undergo surgery based on imaging results after 8 weeks Receive postoperative serplulimab combined with adjuvant chemotherapy or adjuvant chemotherapy alone
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Have a full understanding of the study and voluntarily sign the Informed Consent Form (ICF);
✓. The tumor is located in the stomach, pathologically confirmed as adenocarcinoma, with clinical stage III (cT3-4aN1-3M0) determined by enhanced CT/MRI examination;
✓. Tumor specimens show PD-L1 positivity (CPS ≥ 1). At the time of enrollment, there must be sufficient tumor tissue available for assessing PD-L1 expression levels (subjects undergoing repeated screening do not need additional PD-L1 testing);
✓. No restriction on gender, aged 18-70 years;
✓. Generally in good condition, with an ECOG performance status of 0-1, and no contraindications to surgery;
✓. Physical condition and organ function allow for major abdominal surgery;
✓. Expected survival ≥ 3 months;
✓. Laboratory test results within 7 days prior to enrollment must meet the following criteria:
. HER2-positive status, defined as IHC3+ or IHC2+ with FISH+; or known MSI-H/dMMR.
✕. Tumor involvement of the esophagogastric junction (EGJ).
✕. Known allergy to citric acid monohydrate, sodium citrate dihydrate, mannitol, or polysorbate (components of the investigational drug).
✕. History or concurrent diagnosis of other malignancies (excluding completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, mucosal carcinoma, superficial bladder cancer, or any other cancer with no recurrence for at least 5 years).
✕. Uncontrolled pericardial effusion, pleural effusion, ascites, gastrointestinal bleeding, or high bleeding risk within 2 weeks prior to enrollment.
✕. Weight loss exceeding 20% within 2 weeks prior to enrollment.
✕. Inability to take oral medication.
✕. History of chemotherapy, radiotherapy, immunotherapy, or surgery for gastric cancer.