Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07621484
PHASE2

HIPEC Priming Followed by Serplulimab Plus SOX/XELOX in Locally Advanced Gastric Cancer

Sponsor: Shanghai Changzheng Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective Exploratory Study of a HIPEC Priming Strategy Followed by Serplulimab Combined With SOX/XELOX as Neoadjuvant Therapy for Locally Advanced Gastric Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-07-01

Completion Date

2028-05-09

Last Updated

2026-06-17

Healthy Volunteers

No

Interventions

PROCEDURE

Hyperthermic Intraperitoneal Chemotherapy

Docetaxel-based hyperthermic intraperitoneal chemotherapy administered after diagnostic laparoscopy in patients with P0/CY0 locally advanced gastric cancer

DRUG

Serplulimab

Serplulimab administered intravenously every 3 weeks as part of neoadjuvant treatment

DRUG

S-1

Oral S-1 administered during neoadjuvant treatment.

DRUG

Capecitabine

Oral capecitabine administered during neoadjuvant treatment.

DRUG

Oxaliplatin

Intravenous oxaliplatin administered as part of SOX/XELOX neoadjuvant chemotherapy.

PROCEDURE

Radical Gastrectomy

Standard radical gastrectomy with D2 lymphadenectomy performed after completion of neoadjuvant therapy.