NCT07085273

Irinotecan Liposome II + 5-FU/LV + Oxaliplatin + Karelizumab in Neoadjuvant Treatment of Gastric Cancer

A Single-arm Clinical Study of Irinotecan Liposome II + 5-FU/LV + Oxaliplatin + Karelizumab for Neoadjuvant Treatment of Gastric Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

For non-esophagogastric union progressive gastric cancer, the current treatment standard is D2 surgical resection combined with postoperative adjuvant chemotherapy, and for those with advanced stage (clinical stage III or above), perioperative chemotherapy mode can be chosen. For progressive esophagogastric combination cancer, neoadjuvant radiotherapy or preoperative chemotherapy can be chosen. Preoperative chemotherapy significantly improves the tumor remission rate and R0 resection rate with good safety. Irinotecan has been widely used in clinical practice, and together with the available data from the Irinotecan Liposome (II) clinical study demonstrated good safety and clinical efficacy, bringing hope for prolonging progression-free survival and overall survival for several tumor patients. In order to further explore the safety and efficacy of the neoadjuvant therapeutic application of irinotecan liposome (II) in patients with gastric cancer, the present study was conducted to provide data to guide future clinical practice.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan Liposomal	FOLFIRINOX + Karelizumab Irinotecan liposomal: 60 mg/m2, IV infusion, d1; 5-FU: 400 mg/m2, IV infusion, d1, followed by 1200 mg/m2/d x 2 days of continuous IV infusion (total 2400 mg/m2, 46-48h infusion); Calcium folinate: 400 mg/m2, IV infusion, d1; Oxaliplatin: 85 mg/m2, IV infusion, d1; Karelizumab: 200 mg, IV infusion, d1; Repeat every 2 weeks.

Timeline

• Start date: 2025-08-15
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2025-07-25
• Last updated: 2025-07-31