Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06148402
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-11-03
Brief Title:
Fruquintinib Plus Camrelizumab and Capecitabine as Salvage Therapy After Progression on FOLFOXIRI-based First-line Treatment in Patients With UnresectableMetastatic Colorectal Cancer
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Fruquintinib Plus Camrelizumab and Capecitabine as Salvage Therapy After Progression on FOLFOXIRI-based First-line Treatment in Patients With UnresectableMetastatic Colorectal Cancer a Prospective Phase II Study
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:
FOLFOXIRI-based regimen is more used as a first-line therapeutic approach for patients diagnosed with unresectable or metastatic colorectal cancer for its superior efficacy However there are no standard recommendations for second-line therapy after progression on FOLFOXIRI with or without targeted therapy Here the investigators conduct this open-label single arm phase II study to evaluate whether fruquintinib in combination with camrelizumab and capecitabine can be the salvage therapy following FOLFOXIRI based regimen for mCRC Patients diagnosed with unresectable or metastatic colorectal cancer progression on FOLFOXIRI-based regimen are includedor patients have progression or untolerated toxicity with irinotecan oxaliplatin and fluorouracil successively within one year patients with BRAF mutation were allowed to receive BRAF inhibitor therapy with or without MEK inhibitor therapy after FOLFOXIRI-based regimen
Patients participated in this study will receive fruquintinib 5 mg once daily 2 weeks on1 week off plus camrelizumab 200 mg Q3W and capecitabine 750mgsquare meter twice 2 weeks on1 week off repeated every three weeks The primary endpoint is Objective Response RateORR The investigators estimated that 30 patients were necessary Secondary endpoints include progression-free survival overall survival safety and exploratory ctDNA for efficacy prediction for unresectable or metastatic colorectal cancer
Patients participated in this study will receive fruquintinib 5 mg once daily 2 weeks on1 week off plus camrelizumab 200 mg Q3W and capecitabine 750mgsquare meter twice 2 weeks on1 week off repeated every three weeks The primary endpoint is Objective Response RateORR The investigators estimated that 30 patients were necessary Secondary endpoints include progression-free survival overall survival safety and exploratory ctDNA for efficacy prediction for unresectable or metastatic colorectal cancer
Detailed Description:
None
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