Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532539
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Single-arm Multicenter Clinical Trial of Definitive Treatment With Cadonilimab Paclitaxel Cisplatin and Radiation for the Treatment of Locally Recurrent and Oligometastatic Endometrial Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The goal of this clinical trial is to evaluate the efficacy and safety of cadonilimab in combination with paclitaxel cisplatin and radiation therapy for the treatment of locally recurrent and oligometastatic endometrial carcinoma The main questions it aims to answer are
1 Does the combination therapy improve the overall response rate ORR progression-free survival PFS disease control rate DCR overall survival OS and safety in participants
2 What are the predictive biomarkers of treatment efficacy and how can this information better guide the use of immune-oncology drugs in combination therapy
Participants will
Receive cadonilimab paclitaxel cisplatin and radiation therapy according to a specified protocol
Visit the clinic for regular checkups and tests throughout the treatment period
Be monitored for and have records kept of ORR PFS DCR OS and safety
Provide hematologic and tissue samples to explore biomarkers
This study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic endometrial carcinoma as well as identify biomarkers to better guide treatment strategies
1 Does the combination therapy improve the overall response rate ORR progression-free survival PFS disease control rate DCR overall survival OS and safety in participants
2 What are the predictive biomarkers of treatment efficacy and how can this information better guide the use of immune-oncology drugs in combination therapy
Participants will
Receive cadonilimab paclitaxel cisplatin and radiation therapy according to a specified protocol
Visit the clinic for regular checkups and tests throughout the treatment period
Be monitored for and have records kept of ORR PFS DCR OS and safety
Provide hematologic and tissue samples to explore biomarkers
This study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic endometrial carcinoma as well as identify biomarkers to better guide treatment strategies
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