Ignite Creation Date:
2024-07-17 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501664
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-09
Brief Title:
Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC
Sponsor:
Rui-hua Xu MD PhD
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Liposomal Irinotecan and 5-FU Versus Irinotecan Irinotecan5-fluorouracil as Second-line Therapy for Patients With Esophageal Squamous Cell Carcinoma A Open-label Randomized Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None