Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405139
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-03
Brief Title:
Nanoliposomal Irinotecan Oxaliplatin Plus Capecitabine as Conversion Therapy of Locally Advanced Colorectal Cancer
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Phase II Study of Nanoliposomal Irinotecan Oxaliplatin Plus Capecitabine as Conversion Therapy for Patients With Locally Advanced Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Neoadjuvant chemotherapy has gained acceptance in treating locally advanced breast cancer esophageal cancer gastric cancer and rectal cancer However the role of neoadjuvant chemotherapy for locally advanced colon cancer is still in the exploratory stage The objective of this study is to explore the efficacy and safety of nanoliposomal irinotecan and oxaliplatin combined with capecitabine as a novel conversion therapy for locally advanced colorectal cancer patients
Detailed Description:
After patients are enrolled they will receive a modified FOLFOXIRI regimen nanoliposomal irinotecan 60mgm2 oxaliplatin 85 mgm2 and capecitabine 800 mgm2 twice daily day 1 to 7 repeated every two weeks The efficacy and resectability were evaluated every four cycles Patients who had lesions that were radically resectable after evaluation will receive surgery This medication will be administrated until disease progression or unacceptable toxicity or resectability or up to a maximum of 12 cycles
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