Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511726
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer A Multicenter Open-label Single-arm Phase II Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
CATPCC-01
Brief Summary:
This is a Phase II clinical study for patients with locally advanced cervical cancer aimed at evaluating the efficacy safety and tolerability of Cadonilimab combined with chemotherapy induction therapy as well as exploring the correlation between the expression level of PD-L1 in tumor samples changes in blood and tumor-local immune-related factors and cells during treatment and the efficacy of Cadonilimab induction therapy The study is divided into two stages with the first stage requiring the enrollment of 9 patients If the number of effective cases is 7 the trial will be terminated if 7 cases it will proceed to the second stage continuing to enroll patients until reaching 29 The Cadonilimab dosing regimen involves immunotherapy combined with chemotherapy induction Cadonilimab and cisplatin and albumin-bound paclitaxel for a total of 2 cycles The radiotherapy and chemotherapy regimen includes cisplatin 30-40 mgm2 once weekly for 5 times external radiation 6MV-X-ray at a dose of 45-60Gy25F and brachytherapy at a dose of 30Gy5F The primary endpoint of the study is ORR with secondary endpoints being OS PFS and DCR
Detailed Description:
None
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