Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443671
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMRMSS Locally Advanced Rectal Cancer
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMRMSS Locally Advanced Rectal Cancer A Prospective Open-label Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
PKUCH-R09
Brief Summary:
The goal of this clinical trial is to learn if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMRMSS locally advanced rectal cancer patients compared with CapeOX It will also learn about the safety of neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX The main questions it aims to answer are
Does neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX improve the pCR rate of mid-high pMMRMSS locally advanced rectal cancer patients
What medical problems do participants have when receiving neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX Researchers will compare Fruquintinib and Tislelizumab combined with mCapeOX to CapeOX to see if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMRMSS locally advanced rectal cancer patients
Participants will
Receive Fruquintinib and Tislelizumab combined with mCapeOX or CapeOX before surgery up to 4 cycles
Receive radical operations and three years follow-up
Keep a diary of their postoperative pathology results and survival
Does neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX improve the pCR rate of mid-high pMMRMSS locally advanced rectal cancer patients
What medical problems do participants have when receiving neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX Researchers will compare Fruquintinib and Tislelizumab combined with mCapeOX to CapeOX to see if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMRMSS locally advanced rectal cancer patients
Participants will
Receive Fruquintinib and Tislelizumab combined with mCapeOX or CapeOX before surgery up to 4 cycles
Receive radical operations and three years follow-up
Keep a diary of their postoperative pathology results and survival
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?:
False
Is an FDA AA801 Violation?:
None