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RECRUITING
NCT06685887
PHASE2

A Clinical Study Evaluating the Efficacy of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

This study is a single-center, prospective, phase II clinical trial aimed at assessing the impact of HIPEC combined with systemic chemotherapy and immune checkpoint inhibitors on the R0 resection rate in patients with peritoneal metastasis from gastric cancer. Furthermore, it seeks to analyze the effects of this treatment strategy on overall survival (OS), progression-free survival (PFS), PCI and adverse reaction rates.

Official title: Phase Ⅱ Study of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2025-02-15

Completion Date

2027-12

Last Updated

2025-04-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

HIPEC

HIPEC treatment (Oxaliplatin, physiological saline at 43°C for 60 min) was performed after the Laparoscopic exploratory surgery.

DRUG

SOX

Oxaliplatin, 130 mg, i.v. + S-1 (40 mg per dose for BSA \<1.25; 60 mg per dose for BSA 1.25 to 1.5; 60 mg per dose for BSA ≥1.5, twice daily for each treatment cycle d1-14, q3w

DRUG

Immune Checkpoint Inhibitors

Tislelizumab, 200 mg, q3w

Locations (1)

Wuhan Union Hospital

Wuhan, Hubei, China