Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543836
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
ctDNA-guided Treatment of TKI Plus PD-1 Inhibitor for Advanced pMMRMSS Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ctDNA-guided Treatment of an Anti-angiogenic TKI Combined With a PD-1 Inhibitor for Advanced pMMRMSS Colorectal Cancer Failed With Standard Therapy a Randomized Controlled Phase 2 Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The efficacy of combining TKI with PD-1 inhibitor in the treatment of advanced MSSpMMR colorectal cancer with low levels of maxVAF in peripheral blood ctDNA failed with standard treatment was assessed compared to standard treatment as chosen by researchers
Detailed Description:
This study is a prospective randomized phase II controlled trial It will include patients with histologically confirmed advanced metastatic pMMRMSS colorectal adenocarcinoma who have failed with treatment with fluoropyrimidine 5-fluorouracil or capecitabine oxaliplatin irinotecan plus bevacizumabcetuximab left-side RASBRAF wild-type and whose peripheral blood ctDNA test shows a maxVAF level lower than 65 Patients will be randomly assigned to receive a TKI a PD-1 inhibitor primarily fruquintinib combined with sintilimab or standard later-line treatment options regorafenib or fruquintinib monotherapy at the discretion of the investigator until disease progression death intolerable adverse events or withdrawal of informed consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None