Ignite Creation Date:
2024-05-06 @ 4:31 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05016869
Status:
UNKNOWN
Last Update Posted:
2022-08-18
First Post:
2021-08-17
Brief Title:
Fruquintinib Plus Capecitabine as Maintenance Treatment of RAS BRAF Wild-type Metastatic Colorectal Cancer
Sponsor:
Chinese Academy of Medical Sciences
Organization:
ChineseAMS
Study Overview
Official Title:
A Phase ⅠbⅡ Study of Fruquintinib Combined With Capecitabine in the First-line Maintenance Treatment of RASBRAF Wild-type Metastatic Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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:
This phase III study was designed to evaluate the efficacy and safety of fruquintinib combination with capecitabine in maintenance treatment after first-line chemotherapy combined with cetuximab
Detailed Description:
At present most studies use chemotherapy combined with cetuximab or cetuximab alone as the maintenance treatment scheme after the first-line regimen containing cetuximab However the skin reaction caused by cetuximab and frequent infusion treatment will bring inconvenience to patients MACBETH study compared the maintenance of bevacizumab with cetuximab although there was no significant difference in PFS between them the Bev group seemed to convey a longer median OS Fruquintinib is a highly selective anti angiogenesis TKI This study aims to explore the efficacy and safety of fruquintinib combined with capecitabine in maintenance treatment after first-line chemotherapy combined with cetuximab Both fruquintinib and capecitabine are orally given so this regimen may provide a maintenance treatment option that is more manageable for patients in clinical practice
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