Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416696
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-11
Brief Title:
Toripalimab for High-risk Locally Advanced 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:
Toripalimab Combined With Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for High-risk Locally Advanced Cervical Cancer the Phase II Single-arm TorCH -CC Study
Status:
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 phase II clinical study assesses the efficacy and safety of Toripalimab combined with chemoradiotherapy CRT followed by Toripalimab maintenance in treating high-risk locally advanced cervical cancer HR-LACC Despite CRT being the standard treatment HR-LACC patients face poor survival outcomes Toripalimab a cost-effective PD-1 inhibitor has shown promise in prior research The primary endpoint is 2-year progression-free survival with the study aiming to improve treatment accessibility and patient prognoses in China
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 Nevertheless the high cost of pembrolizumab poses a significant barrier for patients in China Toripalimab the first domestically approved PD-1 inhibitor in China has shown good safety and efficacy in previous studies and is more affordable This phase II single-arm open-label study aims to evaluate the efficacy and safety of Toripalimab combined with CRT followed by Toripalimab maintenance therapy in 130 patients with stages III-IVA cervical cancer The primary endpoint is the 2-year PFS The study is expected to contribute to the implementation of precision and personalized treatment for HR-LACC in China with the potential to improve patient survival rates and quality of life
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