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Effect of HIPEC After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer
Sponsor: The First Hospital of Jilin University
Summary
The study focuses on patients with locally advanced gastric adenocarcinoma (cT3N+M0 and cT4aN+/-M0), assessing the feasibility, surgical safety, and oncological benefit of prophylactic HIPEC treatment following laparoscopic D2 radical surgery.
Official title: Effect of Prophylactic Hyperthermic Intraperitonal Chemotherapy（HIPEC）After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer（cT3N+M0 and cT4aN+/-M0）: A Randomized-controlled Study
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
302
Start Date
2024-08
Completion Date
2030-07
Last Updated
2024-07-31
Healthy Volunteers
Yes
Conditions
Interventions
cisplatin oxaliplatin tegafur
Within 48 hours postoperative, the first infusion was performed with 3000-4000 ml of saline and 50 mg/m2 cisplatin at 43°C, with an infusion rate of 600 ml/min for a duration of 2 hours. During treatment, close attention is given to the patient's heart rate, blood pressure, oxygenation, and other vital signs. A total of 2 HIPEC treatments were conducted, each 48 hours apart. Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX: intravenous injection of oxaliplatin (130 mg/m2) on the first day and oral administration of tegafur (40-60 mg twice daily, with doses adjusted for body surface area: \<1.25 m2, 40 mg; 1.25m2 ≤ body surface area ≤ 1.5m2, 50mg; body surface area \>1.5m2, 60 mg bid) from day 1 to 14.