Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368141
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-11-27
Brief Title:
Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor ICI Therapy in Locally Advanced Colon Cancer
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor ICI Therapy in Locally Advanced Colon Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
NeoCHIC
Brief Summary:
The goal of this clinical trial is to learn the effect of neoadjuvant chemotherapy plus sequential immune checkpoint inhibitor ICI therapy in locally advanced colon cancer The main questions it aims to answer are
Does this neoadjuvant chemotherapy increase the pathologic complete response pCR of locally advanced colon cancer
Does this neoadjuvant chemotherapy improve the long-term survival of locally advanced colon cancer
Participants will receive
a pre-operative CAPEOX capecitabine oral oxaliplatin ivregimen
a sequential CAPEOX plus Serplulimab regimen
a standard complete mesocolic excision CME operation
Does this neoadjuvant chemotherapy increase the pathologic complete response pCR of locally advanced colon cancer
Does this neoadjuvant chemotherapy improve the long-term survival of locally advanced colon cancer
Participants will receive
a pre-operative CAPEOX capecitabine oral oxaliplatin ivregimen
a sequential CAPEOX plus Serplulimab regimen
a standard complete mesocolic excision CME operation
Detailed Description:
None
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