Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548763
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Oral Topotecan With Toripalimab for Patients With Endometrial Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Oral Topotecan in Combination With Toripalimab for Patients With AdvancedRecurrent Endometrial Cancer a Phase II Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to explore the safety and efficacy of oral topotecan combined with toripalimab in treating advancedrecurrent endometrial cancer through a single-center prospective single-arm phase II clinical trial The goal is to explore the first-line treatment options for endometrial cancer patients in the era of immunotherapy to improve the overall treatment level and prognosis of endometrial cancer
Detailed Description:
1 Overall Design This trial is a single-center prospective single-arm phase II clinical trial to evaluate the safety and efficacy of oral topotecan combined with toripalimab in treating advancedrecurrent endometrial cancer
2 Experimental observation indicators 1 Main indicators progression-free survival PFS 2 Other indicators overall survival OS objective response rate ORR adverse reactions changes in immune-related factors and biomarkers
3 Sample size calculation This clinical trial aims to evaluate the safety and efficacy of oral topotecan combined with toripalimab in treating advancedrecurrent endometrial cancer patients Based on literature reports the median PFS of patients with advancedrecurrent endometrial cancer is 38 months In comparison the experimental group is expected to have a median PFS of 7 months with an alpha value of 005 Follow-up for 1 year is conducted considering a 10 dropout rate This study plans to include 30 patients with advancedrecurrent endometrial cancer
Mid-term analysis Expected ORR not less than 15 with a minimum of 19 enrolled cases for mid-term analysis at least 3 cases of CR or PR
4 Methods Topotecan 14mg orally administered d1-5toripalimab 240mg intravenous drip d1 q3w until disease progression or toxicity intolerance
5 Data Processing Enter data and use SPSS statistical software for statistical analysis Statistical analyst Clinical Statistics Department of Fudan University Cancer Hospital Mailing address 270 Dongan Road Shanghai
2 Experimental observation indicators 1 Main indicators progression-free survival PFS 2 Other indicators overall survival OS objective response rate ORR adverse reactions changes in immune-related factors and biomarkers
3 Sample size calculation This clinical trial aims to evaluate the safety and efficacy of oral topotecan combined with toripalimab in treating advancedrecurrent endometrial cancer patients Based on literature reports the median PFS of patients with advancedrecurrent endometrial cancer is 38 months In comparison the experimental group is expected to have a median PFS of 7 months with an alpha value of 005 Follow-up for 1 year is conducted considering a 10 dropout rate This study plans to include 30 patients with advancedrecurrent endometrial cancer
Mid-term analysis Expected ORR not less than 15 with a minimum of 19 enrolled cases for mid-term analysis at least 3 cases of CR or PR
4 Methods Topotecan 14mg orally administered d1-5toripalimab 240mg intravenous drip d1 q3w until disease progression or toxicity intolerance
5 Data Processing Enter data and use SPSS statistical software for statistical analysis Statistical analyst Clinical Statistics Department of Fudan University Cancer Hospital Mailing address 270 Dongan Road Shanghai
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None