Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280495
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-20
Brief Title:
Neoadjuvant Serplulimab Bevacizumab With FOLFOX vs FOLFOX Alone in RASBRAF WT pMMRMSS CRC Patients
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Neoadjuvant Combination of Serplulimab and Bevacizumab With FOLFOX Versus FOLFOX Alone for Resectable Liver Metastases in RASBRAF Wild-Type pMMRMSS Colorectal Cancer Patients
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:
The primary objective of this study is to assess whether the addition of Serplulimab a PD-1 inhibitor and Bevacizumab an anti-angiogenesis agent to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver increase T lymphocyte infiltration and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases RASBRAF wild-type pMMRMSS compared to FOLFOX alone
Detailed Description:
In this prospective multi-center clinical trial titled INTENSIFY we seek to evaluate the potential benefits of integrating Serplulimab and Bevacizumab with the standard FOLFOX chemotherapy regimen as neoadjuvant treatment for surgically resectable colorectal cancer liver metastases CRLM Colorectal cancer remains a leading cause of global cancer-related morbidity and mortality with liver metastases accounting for a significant proportion Our primary objective is to investigate whether the addition of Serplulimab a PD-1 inhibitor and Bevacizumab an anti-angiogenesis agent can improve the postoperative prognosis for patients with RASBRAF wild-type pMMRMSS CRLM We aim to address critical questions regarding the efficacy of this combined treatment in enhancing the immune microenvironment within the liver ultimately leading to increased T lymphocyte infiltration and improved patient outcomes The study will involve a randomized assignment of patients to either the standard FOLFOX chemotherapy arm or the experimental arm receiving FOLFOX in combination with Serplulimab and Bevacizumab Participants will undergo neoadjuvant treatment surgical resection and regular follow-up assessments to evaluate treatment response recurrence rates and overall survival By comparing outcomes between the two groups specifically assessing factors like recurrence-free survival overall survival and changes in the immune microenvironment we aim to provide valuable insights into the optimization of treatment strategies for this specific subset of colorectal cancer patients
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