Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321081
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-14
Brief Title:
ICE Study Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC
Sponsor:
Beijing Hospital
Organization:
Beijing Hospital
Study Overview
Official Title:
ICE Study a Clinical Study of the Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This is a non-profit phase II open clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen in pre-treated RASBRAF wild type metastatic colorectal cancer patients according to liquid biopsy at baseline Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit complete or partial response from both of them no matter whether they had treated by any PD-1 inhibitor before
Detailed Description:
This is a non-profit phase II open-label clinical study of the combination irinotecan plus cetuximab and envafolimab as a rechallenge regimen in pre-treated RASBRAF wild type metastatic colorectal cancer patients according to liquid biopsy at baseline Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit complete or partial response from both of them no matter whether they had treated by any PD-1 inhibitor before
30 patients will be treated with irinotecan plus cetuximab and envafolimab For each patient before treatment a blood sample will be obtained and analyzed for circulating free tumorDNA to identify RASBRAF wild type patient to be enrolled
The same procedure will be performed at progression of the disease Treatment will continue until
disease progression significant clinical deterioration any criterion for withdrawal from the trial or trial drug is fulfilled treatment may continue past the initial determination of disease progression according to RECIST 11 if the subjects performance status has remained stable and if in the opinion of the Investigator the subject will benefit from continued treatment and if other criteria are fulfilled as outlined in the protocol that is no new symptoms or worsening of existing symptoms and no decrease in performance score
30 patients will be treated with irinotecan plus cetuximab and envafolimab For each patient before treatment a blood sample will be obtained and analyzed for circulating free tumorDNA to identify RASBRAF wild type patient to be enrolled
The same procedure will be performed at progression of the disease Treatment will continue until
disease progression significant clinical deterioration any criterion for withdrawal from the trial or trial drug is fulfilled treatment may continue past the initial determination of disease progression according to RECIST 11 if the subjects performance status has remained stable and if in the opinion of the Investigator the subject will benefit from continued treatment and if other criteria are fulfilled as outlined in the protocol that is no new symptoms or worsening of existing symptoms and no decrease in performance score
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