Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434090
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Liposomal Irinotecan Plus Bevacizumab in Irinotecan-refractory Metastatic Colorectal Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Liposomal Irinotecan Plus Bevacizumab in Irinotecan-refractory Metastatic Colorectal Cancera Multicenter Phase III 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:
None
Brief Summary:
To evaluate the efficacy and safety of liposomal irinotecan plus bevacizumab in irinotecan-refractory metastatic colorectal cancer
Detailed Description:
The standard treatment regimen based on irinotecan with or without bevacizumab is commonly used in metastatic colorectal cancer With administration of traditional irinotecan the parent drug and active metabolite SN-38 exist in the form of active lactone and carboxylate and the lactone ring structure is unstable in neutral and alkaline solutions In physiological pH conditions the active lactone rapidly hydrolyzes to the inactive carboxylate thereby reducing the efficacy so there is certain limitation in clinical application
Liposomes Irinotecan load the active substance irinotecan into liposomes so that it can be slowly released in the body and achieve the effect of reducing toxicity and increasing efficacyAfter being rationally designed irinotecan liposomes can also take advantage of the high permeability and retention effect EPR to specifically target the tumor area increase the amount of drug taken up by cancer cells reduce the dosage improve efficacy and reduce side effects
We are currently conducting an Phase III study in mCRC patients who have previously received irinotecan After determining the maximum tolerable dose MTD of irinotecan liposomes in the combined regimen of irinotecan liposomes and bevacizumab we will further explore the safety and initial efficacy of irinotecan liposomes combined with bevacizumab
Liposomes Irinotecan load the active substance irinotecan into liposomes so that it can be slowly released in the body and achieve the effect of reducing toxicity and increasing efficacyAfter being rationally designed irinotecan liposomes can also take advantage of the high permeability and retention effect EPR to specifically target the tumor area increase the amount of drug taken up by cancer cells reduce the dosage improve efficacy and reduce side effects
We are currently conducting an Phase III study in mCRC patients who have previously received irinotecan After determining the maximum tolerable dose MTD of irinotecan liposomes in the combined regimen of irinotecan liposomes and bevacizumab we will further explore the safety and initial efficacy of irinotecan liposomes combined with bevacizumab
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