Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356714
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-05
Brief Title:
Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens for the Treatment of Potentially Hazardous Colorectal Cancer SD Status
Sponsor:
Sun Jing
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
An Open Intervention Study of Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens for the Treatment of Potentially Hazardous Colorectal Cancer SDStable Disease Status
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Evaluate the efficacy and safety of Nocardia rubra cell wall skeleton in combination with prior second- or third-line regimens for the treatment of potentially hazardous colorectal cancer SDStable Disease status in the real world
Detailed Description:
This is a prospective interventional clinical trial investigating the efficacy and safety of Nocardia rubra cell wall skeleton in combination with prior second- or third-line regimens for the treatment of potentially hazardous colorectal cancer SD Stable Disease status in the real world
Enrollment requirements were patients who had received prior second- or third-line therapy for advanced or metastatic colorectal cancer and presented with a potentially harmful SD status
The potentially hazardous SD Stable Disease state is defined as an increase in SLD Sum of Longest Diameters by less than 20 according to RECIST 11 criteria with an absolute increase of SLD 5mm from the nadir a serum CEA Carcinoembryonic Antigen level below 100 ngml during stable disease with two consecutive measurements of 10 ngml or more with a testing interval of at least one month or a serum CEA level of 10 ngml or more during stable disease with a gradual increase in CEA after two consecutive measurements with a testing interval of at least one month a serum CA19-9 level below 600 ngml during stable disease with two consecutive measurements of 60 ngml or more with a testing interval of at least one month or a serum CEA level of 60 ngml or more during stable disease with a gradual increase in CEA after two consecutive measurements with a testing interval of at least one month Meeting any one of the above criteria can be considered as the presence of a potentially hazardous SD state
Enrollment requirements were patients who had received prior second- or third-line therapy for advanced or metastatic colorectal cancer and presented with a potentially harmful SD status
The potentially hazardous SD Stable Disease state is defined as an increase in SLD Sum of Longest Diameters by less than 20 according to RECIST 11 criteria with an absolute increase of SLD 5mm from the nadir a serum CEA Carcinoembryonic Antigen level below 100 ngml during stable disease with two consecutive measurements of 10 ngml or more with a testing interval of at least one month or a serum CEA level of 10 ngml or more during stable disease with a gradual increase in CEA after two consecutive measurements with a testing interval of at least one month a serum CA19-9 level below 600 ngml during stable disease with two consecutive measurements of 60 ngml or more with a testing interval of at least one month or a serum CEA level of 60 ngml or more during stable disease with a gradual increase in CEA after two consecutive measurements with a testing interval of at least one month Meeting any one of the above criteria can be considered as the presence of a potentially hazardous SD state
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