NCT06525714

Effect of HIPEC After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 302 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Patients meeting the inclusion criteria will undergo laparoscopic D2 radical surgery. Before closing the abdomen during surgery, heat perfusion tubes are inserted, typically placing four tubes in a cross arrangement. Two drainage tubes at the pelvic floor exit through the upper abdomen, and two drainage tubes at the hepatorenal and splenorenal recesses exit through the lower abdomen, thus completing the tube placement. 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. HIPEC is not performed postoperative. 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.

Conditions

• Gastric Cancer
• Survival Rate

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2029-07-01
• Completion: 2030-07-01
• First posted: 2024-07-29
• Last updated: 2024-07-31