drugset / Trial / NCT07085273

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

NCT07085273 ↗

Phase 2 Not yet recruiting 33 enrolled The First Affiliated Hospital of Zhengzhou University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-08-15
Primary completion
2026-12-31
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Liposomal Unknown 60 mg/m2 Intravenous

Indications