Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456515
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-21
Brief Title:
Regorafenib and Sintilimab in Combination With Electroacupuncture in MSS CRC
Sponsor:
The First Peoples Hospital of Changzhou
Organization:
The First Peoples Hospital of Changzhou
Study Overview
Official Title:
A Single-Arm Multicenter Phase II Clinical Study of Regorafenib and Sintilimab in Combination With Electroacupuncture in Patients With MSS Advanced Colorectal Cancer Who Have Failed More Than Second-Line Standard Chemotherapy
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:
None
Brief Summary:
The aim of this clinical trial is to find out whether Regorafenib and Sintilimab in combination with electroacupuncture works in treating participants with microsatellite stable MSS advanced colorectal cancer who have failed one or more second-line standard chemotherapy regimens It will also learn about the efficacy and safety of the combination therapy The main questions the trial aims to answer are
Does combination therapy reduce the overall survival time What medical problems do people have when they take combination therapy
Participants will
Regorafenib take for 2 weeks and stop for 1 week Sintilimab intravenous every 3 weeks Electroacupuncture was performed 1 day before on the day of and on the 2nd day after each cycle of Sintilimab administration and patients completed 3 treatments in week 1 followed by 1 treatment per week for 2 weeks with 5 treatments per dosing
Does combination therapy reduce the overall survival time What medical problems do people have when they take combination therapy
Participants will
Regorafenib take for 2 weeks and stop for 1 week Sintilimab intravenous every 3 weeks Electroacupuncture was performed 1 day before on the day of and on the 2nd day after each cycle of Sintilimab administration and patients completed 3 treatments in week 1 followed by 1 treatment per week for 2 weeks with 5 treatments per dosing
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