Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427005
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-19
Brief Title:
Fruquintinib Plus S-1 and Raltitrexed RSF for mCRC
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Fruquintinib Combined With S-1 and Raltitrexed for Patients With Metastatic Colorectal Cancer Refractory to Standard Therapies A 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:
Based on the FRECO-2 study Fruquintinib has become one of the standard third-line treatments for advanced colorectal cancer however its objective response rate ORR remains low Our previous studies have shown that the combination of raltitrexed and S-1 - bevacizumab is effective and provides a significant survival benefit in patients with metastatic colorectal cancer mCRC who are refractory to standard treatments This study aims to evaluate the efficacy and safety of combining Fruquintinib with S-1 and raltitrexed in these patients
Detailed Description:
Conducted at West China Hospital in China this investigator-initiated open-label single-arm phase II trial included patients with mCRC that had progressed following treatment with fluoropyrimidine irinotecan and oxaliplatin and had at least one measurable lesion Patients could have previously received anti-EGFR for tumors with wild-type RAS and anti-VEGF therapy in the first or second line including those who had been treated with bevacizumab in two consecutive chemotherapy regimens Participants received Fruquintinib 5 mg daily for 14 days followed by a 7-day break oral S-1 80-120 mg daily for 14 days followed by a 7-day break and raltitrexed 3 mgm² on day 1 with a maximum dose of 5 mg every 3 weeks The primary endpoint was the ORR while secondary endpoints included progression-free survival PFS overall survival OS and toxicity
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?:
False
Is an FDA AA801 Violation?:
None