Toripalimab Combined With Definitive CCRT for LACC Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRuijin Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Toripalimab
- CCRT
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov