Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547203
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Cetuximab Irinotecan Toripalimab in RASBRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Negative Ultraselection of Patients With RASBRAF Wild-type Refractory Right-Sided Metastatic Colorectal Cancer Receiving Cetuximab in Combination With Toripalimab and Irinotecan A Phase II Single-arm Study
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 objective of this clinical trial is to evaluate the efficacy and safety of cetuximab combined with PD-1 inhibitor and irinotecan in negative ultraselection RASBRAF wild-type refractory right-sided metastatic colorectal cancer
Detailed Description:
The present study focuses on exploring the effectiveness and safety of cetuximab combined with a PD-1 inhibitor and irinotecan in treating refractory right-sided metastatic colorectal cancer mCRC patients who are negative ultraselected for RASBRAF mutations Colorectal cancer ranks among the most prevalent digestive malignancies globally with right-sided mCRC generally exhibiting poorer outcomes than left-sided cases Current treatment guidelines vary based on genetic mutations and tumor location recommending cetuximab for left-sided RASBRAF wild-type mCRC and alternative therapies for right-sided or mutated cases Despite limited clinical data on EGFR inhibitors for right-sided mCRC retrospective analyses suggest varying efficacy outcomes The study aims to address these gaps by investigating cetuximab and PD-1 inhibitor combination therapy in this specific patient population potentially enhancing treatment options for refractory mCRC
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