Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690035
Status:
WITHDRAWN
Last Update Posted:
2024-07-09
First Post:
2023-01-10
Brief Title:
Tislelizumab Combined With Fruquintinib for Metastatic pMMRMSS Colorectal Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
PD-1 Antibody Tislelizumab Combined With VEGFR 123 Inhibitor Fruquintinib for ARID1A-mutated Metastatic pMMRMSS Colorectal Cancer an Open-label Multi-center Phase II Clinical Trial
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to slow patient recruiting No patients were enrolled 12 months after study initiation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label phase II study with the aim of investigating the efficacy and safety of Tislelizumab Fruquintinib combination therapy in ARID1A-mutated pMMRMSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine oxaliplatin and irinotecan Patients with hypermutated CRC that carries POLEPOLD1 mutations cannot be included
Detailed Description:
In this open-label phase II study patients with ARID1A-mutated pMMRMSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine oxaliplatin and irinotecan will be scheduled for Tislelizumab 200mg ivdrip Q3W day1 Fruquintinib 5mgday Q3W day1-14 until intolerable toxicity disease progression or death Primary endpoint of this study is ORR and secondary endpoints are OS PFS DCR 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