Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419673
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-14
Brief Title:
Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Induced and Concurrent Serplulimab Plus Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for Stage III-IVA Cervical Cancer a Prospective Multicenter Randomized Open Controlled Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 randomized open controlled clinical trial aimed at evaluating the effectiveness and safety of serplulimab plus chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma adenocarcinoma and adenosquamous cell carcinoma patients who have not received prior treatment
Detailed Description:
Cervical cancer is the most prevalent malignant tumor of the female reproductive system in China with an estimated 150700 new cases and 55700 new deaths annually Concurrent chemoradiotherapy CRT remains the standard treatment for locally advanced cervical cancer LACC However for high-risk LACC HR-LACC patients the 2-year progression-free survival PFS rate is only 57-62 and the 5-year overall survival OS rate is 52-64 which are the leading causes of patient mortality The KEYNOTE-A18 study demonstrated that the combination of pembrolizumab and CRT reduced the progression risk and death risk by 30 and 27 respectively for HR-LACC patients Following this the FDA approved pembrolizumab in combination with CRT for the treatment of newly diagnosed stages III-IVA cervical cancer in January 2024 This prospective multicenter randomized controlled clinical trial study aims to evaluate the effectiveness and safety of serplulimab induced and combined chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma adenocarcinoma and adenosquamous cell carcinoma patients who have not received prior treatment
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