Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403709
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-01
Brief Title:
Irinotecan TAS-102 Plus Bevacizumab as a Third-Line or Beyond Therapy in mCRC Patients
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 Irinotecan Plus TrifluridineTipiracil TAS-102 in Combination With Bevacizumab as a Third-Line or Beyond Therapy for Patients With Metastatic Colorectal Cancer mCRC
Status:
ACTIVE_NOT_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:
Currently the approved third-line treatments for metastatic colorectal cancer mCRC include regorafenib fruquintinib and trifluridinetipiracilTAS-102 In recent years several phase III studies evaluated the combination of TAS-102 and bevacizumab in mCRC patients who were refractory to standard therapies and showed promising antitumor efficacy and manageable toxicity In this single-center phase II study the investigators explored the efficacy and safety of irinotecan TAS-102 plus bevacizumab in a third-line or beyond therapy for patients with mCRC
Detailed Description:
The mCRC patients who are refractory to standard therapies and need a third-line or beyond therapy are eligible Patients who previously received irinotecan while progressing during maintenance therapy are also eligible
These patients received an intravenous infusion of irinotecan 150mgm2 on day 1 plus bevacizumab 5 mgkg on day 1 and an oral administration of TAS-10230 mgm2 given bid on days 1-5 repeated every 14 days
The primary endpoint was the objective response rate ORR and the secondary endpoints included progression-free survival PFS overall survival OS and safety
These patients received an intravenous infusion of irinotecan 150mgm2 on day 1 plus bevacizumab 5 mgkg on day 1 and an oral administration of TAS-10230 mgm2 given bid on days 1-5 repeated every 14 days
The primary endpoint was the objective response rate ORR and the secondary endpoints included progression-free survival PFS overall survival OS and safety
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