Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486545
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-21
Brief Title:
Liposomal Irinotecan Combination Regimen for Second-line Treatment of Advanced Gastric Cancer
Sponsor:
Hunan Cancer Hospital
Organization:
Hunan Cancer Hospital
Study Overview
Official Title:
Liposomal Irinotecan Combined With Albumin-bound Paclitaxel for Second-line Treatment of Advanced Gastric Cancer a Single-arm Single-center Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Liposomal irinotecan intravenous infusion 90min d1
Grade 150mgm2 Grade 260mgm2 Grade 370mgm2 Albumin-paclitaxel 150mgm2 intravenous infusion d1 DLT was observed for 2 weeks the first cycle The same subject received only one dose of liposomal irinotecan during the study All subjects underwent protocol-mandated examinations during treatment to observe safety and initial efficacy If the patient volunteers and the investigator determines that the benefits of continuing the original regimen outweigh the risks the subject may continue to receive treatment for metastatic disease The drug was repeated every 2 weeks for up to 6 cycles and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patients adverse reactions and physical status and the remaining single-agent maintenance therapy was performed Until there is a possibility of surgery disease progression intolerable toxicity or the patient withdraws informed consent whichever comes first
Grade 150mgm2 Grade 260mgm2 Grade 370mgm2 Albumin-paclitaxel 150mgm2 intravenous infusion d1 DLT was observed for 2 weeks the first cycle The same subject received only one dose of liposomal irinotecan during the study All subjects underwent protocol-mandated examinations during treatment to observe safety and initial efficacy If the patient volunteers and the investigator determines that the benefits of continuing the original regimen outweigh the risks the subject may continue to receive treatment for metastatic disease The drug was repeated every 2 weeks for up to 6 cycles and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patients adverse reactions and physical status and the remaining single-agent maintenance therapy was performed Until there is a possibility of surgery disease progression intolerable toxicity or the patient withdraws informed consent whichever comes first
Detailed Description:
This is a single-arm single-center clinical study to evaluate the efficacy and safety of liposomal irinotecan combined with albumin paclitaxel regimen for second-line treatment of advanced gastric cancer Using a 33 study design 9 to 18 eligible patients with unresectable or locally advanced gastric cancer and gastroesophageal junction adenocarcinoma will receive liposomal irinotecan albumin paclitaxel combination therapy
Three dose groups of liposomal irinotecan 50mgm2 60 mgm2 and 70 mgm2 were preset and a fixed dose of albumin paclitaxel 150mgm2 intravenous infusion d1 was administered for one cycle The dose of liposomal irinotecan was gradually increased from the low-dose group to the high-dose group and DLT was observed for 2 weeks the first cycle The same subject received only one dose of liposomal irinotecan during the study All subjects underwent protocol-mandated examinations during treatment to observe safety and initial efficacy If the patient volunteers and the investigator determines that the benefits of continuing the original regimen outweigh the risks the subject may continue to receive treatment for metastatic disease The drug was repeated every 2 weeks for up to 6 cycles and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patients adverse reactions and physical status and the remaining single-agent maintenance therapy was performed Until there is a possibility of surgery disease progression intolerable toxicity or the patient withdraws informed consent whichever comes first
Main study indicators Maximum tolerated dose MTD of liposomal irinotecan in the combination regimen Secondary study measures dose-limiting toxicity DLT of liposomal irinotecan objective response rate ORR disease control rate DCR progression-free survival PFS and overall survival OS
Three dose groups of liposomal irinotecan 50mgm2 60 mgm2 and 70 mgm2 were preset and a fixed dose of albumin paclitaxel 150mgm2 intravenous infusion d1 was administered for one cycle The dose of liposomal irinotecan was gradually increased from the low-dose group to the high-dose group and DLT was observed for 2 weeks the first cycle The same subject received only one dose of liposomal irinotecan during the study All subjects underwent protocol-mandated examinations during treatment to observe safety and initial efficacy If the patient volunteers and the investigator determines that the benefits of continuing the original regimen outweigh the risks the subject may continue to receive treatment for metastatic disease The drug was repeated every 2 weeks for up to 6 cycles and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patients adverse reactions and physical status and the remaining single-agent maintenance therapy was performed Until there is a possibility of surgery disease progression intolerable toxicity or the patient withdraws informed consent whichever comes first
Main study indicators Maximum tolerated dose MTD of liposomal irinotecan in the combination regimen Secondary study measures dose-limiting toxicity DLT of liposomal irinotecan objective response rate ORR disease control rate DCR progression-free survival PFS and overall survival OS
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