Clinical Trials Directory

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RecruitingNCT06288360

Neoadjuvant Immunochemotherapy in PD-L1-negative LACC

Neoadjuvant Chemotherapy Plus Camrelizumab in PD-L1-negative Locally Advanced Cervical Cancer: a Multicentre, Single-arm, Phase 2 Trial

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Tongji Hospital · Academic / Other
Sex
Female
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGCamrelizumab200 mg, intravenously, 20-60 min. 2 times, every 21 days
DRUGPaclitaxel-albumin260 mg/m² over 30 min, 3 times, every 21 days
DRUGCisplatin4 h, 75-80 mg/m², 3 times, every 21 days
PROCEDUREradical surgeryRadical hysterectomy + pelvic lymphadenectomy 士 para-aortic lymphadenectomy

Timeline

Start date
2024-09-12
Primary completion
2025-12-31
Completion
2030-12-12
First posted
2024-03-01
Last updated
2025-03-20

Locations

12 sites across 1 country: China

Source: ClinicalTrials.gov record NCT06288360. Inclusion in this directory is not an endorsement.