Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467786
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-28
Brief Title:
Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cancer
Sponsor:
Tang-Du Hospital
Organization:
Tang-Du Hospital
Study Overview
Official Title:
The Therapeutic Effect of Irinotecan Liposomes Combined With CisplatinCarboplatin for Platinum Sensitive Recurrent Small Cell Lung Cancer
Status:
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:
This study is a prospective multicenter single arm Phase II exploratory study It is expected to include 24 first-line patients with small cell lung cancer who have progressed after 6 months of treatment with platinum containing regimens and receive treatment with irinotecan liposomes combined with cisplatin or carboplatin regimens
Detailed Description:
Based on literature research and the birth of independently developed irinotecan liposomes by Shiyao we plan to conduct a therapeutic study on the combination of irinotecan liposomes and cisplatincarboplatin for platinum sensitive recurrent small cell lung cancer The aim is to explore the efficacy and safety of the combination of irinotecan liposomes and platinum based chemotherapy regimen in first-line treatment of small cell lung cancer patients who have progressed after 6 months using platinum based regimens providing better clinical evidence for use
The research unit is the Second Affiliated Hospital of Air Force Military Medical University The study includes screening period within 28 days treatment period and follow-up period safety follow-up and PFS follow-up The subjects signed an informed consent form and underwent baseline examination during the screening period Patients who met the inclusion and exclusion criteria entered the treatment period All subjects completed the relevant examinations specified in the protocol during the treatment process to observe safety tolerance and efficacy The same subject only received one dosing plan during the study period After the treatment period ends enter the follow-up period
The research unit is the Second Affiliated Hospital of Air Force Military Medical University The study includes screening period within 28 days treatment period and follow-up period safety follow-up and PFS follow-up The subjects signed an informed consent form and underwent baseline examination during the screening period Patients who met the inclusion and exclusion criteria entered the treatment period All subjects completed the relevant examinations specified in the protocol during the treatment process to observe safety tolerance and efficacy The same subject only received one dosing plan during the study period After the treatment period ends enter the follow-up period
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