NCT06501664

Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC

Liposomal Irinotecan and 5-FU Versus Irinotecan / Irinotecan+5-fluorouracil as Second-line Therapy for Patients With Esophageal Squamous Cell Carcinoma: A Open-label, Randomized Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Rui-hua Xu, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the efficacy and safety of liposome irinotecan +5-FU and irinotecan / irinotecan +5-FU regimens in the second-line treatment of esophageal squamous cell carcinoma (ESCC).

Detailed description

Esophageal cancer was ranked the sixth most common cancer worldwide and seventh most common cause of cancer-related deaths. ESCC is the most common histologic subtype in Asia. The National Comprehensive Cancer Network (NCCN) guidelines recommend immune checkpoint inhibitors, taxanes, fluorouracils and/or irinotecan as the second-line treatment of ESCC. Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan. It adopts a special loading technology to encapsulate traditional irinotecan in liposomes, which can avoid its hydrolysis under physiological conditions, increase the affinity with cancer cells, overcome drug resistance, increase the drug uptake by cancer cells, reduce the drug dose, improve the efficacy and reduce the toxic side effects. The aim of this study is to compare the efficacy and safety of liposome irinotecan +5-FU and irinotecan / irinotecan +5-FU regimens in the second-line treatment of esophageal squamous cell carcinoma (ESCC).

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	liposomal irinotecan	Liposomal irinotecan 70 mg/m²
DRUG	5-FU	5-FU 400 mg/m² bolus then 2400 mg/m2 over 46 h
DRUG	LV	LV 400 mg/m²
DRUG	Irinotecan	Irinotecan 180 mg/m²

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-11-30
• Completion: 2027-11-30
• First posted: 2024-07-15
• Last updated: 2024-07-15