Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-28 @ 4:24 AM
Study NCT ID:
NCT06288360
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2024-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Immunochemotherapy in PD-L1-negative LACC
Sponsor:
Tongji Hospital
Organization:
Study Overview
Official Title:
Neoadjuvant Chemotherapy Plus Camrelizumab in PD-L1-negative Locally Advanced Cervical Cancer: a Multicentre, Single-arm, Phase 2 Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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. Patients will receive an initial course of priming neoadjuvant chemotherapy, followed by two courses of neoadjuvant immunochemotherapy. The study aims to evaluate the effects of combining neoadjuvant chemotherapy with a PD-1 inhibitor on tumor remission rates, surgical complications, positive margin rates, and patient survival. Additionally, the trial will investigate changes in local immune-related factors and tumor cells during treatment, as well as identify biomarkers that may influence the efficacy of neoadjuvant immunochemotherapy.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: