Toripalimab Combined With Definitive CCRT for LACC Patients
Toripalimab Combined With Definitive Chemoradiotherapy for Locally Advanced Cervical Squamous Cell Carcinoma Patients
Ruijin Hospital
150 participants
Feb 2, 2024
INTERVENTIONAL
Conditions
Summary
Cervical cancer constitutes a significant health burden for women globally. While most patients with early-stage disease can be cured with radical surgery or chemoradiotherapy, patients with high-risk locally advanced disease or with recurrent/metastatic disease have a poor prognosis with standard treatments. Immunotherapies are a rational treatment for this HPV-driven cancer that commonly expresses programmed cell death ligand-1. Toripalimab, a humanized immunoglobulin G4 monoclonal antibody against PD-1, showed promising anti-tumor efficacy in multiple solid tumors. This randomised study is evaluating toripalimab combined with CCRT versus CCRT alone for treatment-naïve LACC.
Eligibility
Inclusion Criteria5
- more than 18 years old females
- had newly diagnosed and previously untreated locally advanced squamous cell carcinoma of the uterine cervix
- FIGO 2018 stage IB3 to IVA with no evidence of distant metastasis
- ECOG PS 0-1 without major organ failure
- signed informed consent voluntarily
Exclusion Criteria3
- previously suffered from immunodeficiency disorders
- had any condition that researchers believed to be associated with increased risk of treatment
- Previously received or currently receiving other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1
Interventions
Toripalimab combined with CCRT
CCRT includes cisplatin (40 mg/m2, once a week for 5 weeks), radiotherapy (45-50.4Gy/25-28Fx, 5 fractions a week, followed by brachytherapy 24-30Gy/3-5Fx)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06256224