Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05790200
Status:
RECRUITING
Last Update Posted:
2023-03-30
First Post:
2023-03-01
Brief Title:
Cadonilimab AK104 in the Treatment of Nasopharyngeal Carcinoma
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
A Phase II Clinical Study of Cadonilimab AK104 Combined With Chemotherapy in the Treatment of PD-1 Inhibitor Resistant Nasopharyngeal Carcinoma
Status:
RECRUITING
Status Verified Date:
2023-03
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 phase II clinical study of Cadonilimab AK104 combined with chemotherapy in the treatment of PD-1 inhibitor-resistant nasopharyngeal carcinoma
Detailed Description:
The purpose is to evaluate the safety and effectiveness of Cadonilimab combined with chemotherapy in the treatment of PD-1 inhibitor-resistant nasopharyngeal carcinoma as the second line and above This study is a single-arm phase II clinical study It is planned to enroll about 30 patients with PD-1 inhibitor resistant nasopharyngeal carcinoma PD-Ll CPS 50 vs50 subjects whose PD-Ll expression could not be evaluated were classified as50 was used as the stratification factor The study will set up a safety induction period It is planned to enroll about 6 PD-1 inhibitor resistant subjects first and the researchers will conduct a preliminary safety assessment If the safety and tolerability are good and the preliminary curative effect signal is observed it will enter the extended group period When about 15 subjects are selected effectiveness analysis will be carried out If 6 of the 15 subjects with severe side effects can not tolerate the researcher may stop the group of subjects after discussion In case of poor safety the researcher decided to revise or stop the study after discussion
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