Treatment Study of Complete Cytoreductive Surgery with Intraperitoneal and Systemic Chemotherapy for Gastric Cancer Patients with Limited Peritoneal Spread

What this Trial Is About

This research aims to evaluate the 6-month disease control rate in patients with gastric adenocarcinoma who have limited peritoneal carcinomatosis or positive peritoneal wash cytology. Peritoneal carcinomatosis in these patients is usually considered an advanced and difficult-to-treat condition, and current palliative chemotherapy options have limited effectiveness. The study focuses on a combined treatment approach involving surgery and chemotherapy to improve outcomes for these patients. Participants will receive complete cytoreductive surgery followed by normothermic intraperitoneal chemotherapy with paclitaxel combined with systemic chemotherapy regimens, either high-dose fluorouracil and cisplatin P-HDFL or capecitabine and oxaliplatin CAPOX. Treatment cycles involve multiple administrations of these therapies on specified days within each cycle. Patients may receive up to 6 or 8 cycles of this combined treatment depending on the chemotherapy regimen, followed by continued systemic chemotherapy alone until disease progression or death. The study is conducted in two stages with predefined patient numbers in each arm based on disease characteristics. During the study, patients will undergo regular monitoring including computed tomography scans every 12 weeks to assess disease status and ascites response. Clinical evaluations will occur every 2 to 3 weeks depending on the chemotherapy used. Peritoneal cytology samples will be collected at surgery and at the start of each treatment cycle. The study also tracks progression-free survival, overall survival, and safety outcomes over periods up to 3 years. Participation may last several months to years depending on treatment response and disease progression.

Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis