Patients with locally advanced gastric cancer (LAGC), particularly those with serosal invasion, remain at high risk of peritoneal recurrence despite standard perioperative treatment. Hyperthermic intraperitoneal chemotherapy (HIPEC) may eradicate free intraperitoneal tumor cells and microscopic peritoneal disease while potentially enhancing systemic anti-tumor immune activation.
This is a prospective, single-center, single-arm exploratory study evaluating a HIPEC priming strategy followed by serplulimab-based neoadjuvant therapy in patients with locally advanced gastric cancer (cT3-4aN+M0). Eligible patients will undergo diagnostic laparoscopy confirming no visible peritoneal metastasis (P0) and negative peritoneal cytology (CY0), followed by docetaxel-based HIPEC.
After recovery from HIPEC, patients will initially receive one cycle of serplulimab combined with fluoropyrimidine monotherapy (S-1 or capecitabine), followed by subsequent cycles of serplulimab combined with SOX/XELOX chemotherapy prior to radical gastrectomy.
The primary endpoints are pathological complete response (pCR) rate and major pathological response (MPR) rate. Secondary endpoints include R0 resection rate, objective response rate (ORR), peritoneal recurrence-free survival (PRFS), overall survival (OS), and safety.
Aged 18 to 75 years (inclusive); gender unrestricted.
Histologically confirmed gastric or gastroesophageal junction adenocarcinoma via endoscopic biopsy.
Clinical stage cT3-4a (imaging evidence of tumor invasion into or penetration through the serosa), N+ (lymph node positive), M0 (no distant organ metastasis), based on the 8th Edition of the AJCC Staging Manual.
HER2-negative disease, defined as HER2 IHC 0 or 1+, or IHC 2+ with negative ISH.
History of other active malignancies within the past 5 years, or the presence of other active malignancies at the time of enrollment. Patients with cured localized tumors-such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, or carcinoma in situ of the breast-are eligible for enrollment.
Presence of documented distant metastases (e.g., liver, lung, or bone metastases) or laparoscopically confirmed peritoneal seeding (P1).
Patients scheduled to undergo, or with a history of having undergone, organ or bone marrow transplantation.
Occurrence of myocardial infarction or poorly controlled arrhythmias (including a QTc interval ≥ 450 ms for males or ≥ 470 ms for females; QTc interval calculated using the Fridericia formula) within 6 months prior to enrollment.
Single group
Hyperthermic Intraperitoneal Chemotherapy
Procedure/SurgeryDocetaxel-based hyperthermic intraperitoneal chemotherapy administered after diagnostic laparoscopy in patients with P0/CY0 locally advanced gastric cancer
Serplulimab
DrugSerplulimab administered intravenously every 3 weeks as part of neoadjuvant treatment
S-1
DrugOral S-1 administered during neoadjuvant treatment.
Capecitabine
DrugOral capecitabine administered during neoadjuvant treatment.
Oxaliplatin
DrugIntravenous oxaliplatin administered as part of SOX/XELOX neoadjuvant chemotherapy.
Radical Gastrectomy
Procedure/SurgeryStandard radical gastrectomy with D2 lymphadenectomy performed after completion of neoadjuvant therapy.
Pathological Complete Response (pCR) Rate
Proportion of patients achieving pathological complete response, defined as the absence of residual viable tumor cells in both the primary tumor and regional lymph nodes after neoadjuvant treatment and radical gastrectomy.
Major Pathological Response (MPR) Rate
Proportion of patients achieving major pathological response, defined as ≤10% residual viable tumor cells in the resected primary tumor specimen following neoadjuvant treatment.
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST version 1.1.
R0 Resection Rate
Proportion of patients achieving microscopically margin-negative (R0) resection.
Peritoneal Recurrence-Free Survival (PRFS)
Time from enrollment to the occurrence of peritoneal metastasis (peritoneal metastasis detected by PET/CT and/or diagnostic laparoscopy).
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