Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-18
Brief Title:
Neoadjuvant Immunochemotherapy in PD-L1-negative LACC
Sponsor:
Tongji Hospital
Organization:
Tongji Hospital
Study Overview
Official Title:
Neoadjuvant Chemotherapy Plus Camrelizumab in PD-L1-negative Locally Advanced Cervical Cancer a Multicentre Single-arm Phase 2 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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 is a multicenter prospective single-arm phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI neoadjuvant chemotherapy plus Camrelizumab for PD-L1-negative locally advanced cervical cancer
Detailed Description:
This multicenter prospective single-arm clinical trial is designed to enroll patients with PD-L1-negative locally advanced cervical cancer with 1 course of priming neoadjuvant chemotherapy followed by 2 courses of neoadjuvant immunochemotherapy to clarify the effects of neoadjuvant chemotherapy combined with a PD-1 inhibitor on tumor remission rate surgical complications and surgical cleanliness and to evaluate the effects of neoadjuvant chemotherapy combined with a PD-1 inhibitor on the survival of patients with locally advanced cervical cancer to clarify the effects of neoadjuvant chemotherapy combined with a PD-1 inhibitor on tumor remission rate surgical complications and complete resection rate and to assess the effects of neoadjuvant chemotherapy combined with a PD-1 inhibitor on the survival of patients with locally advanced cervical cancer and to explore the changes of local immune-related factors and tumor cells during the treatment process as well as biomarkers that affect the efficacy of PD-1 combination therapy
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