Toripalimab Combined With Definitive CCRT for LACC Patients

Recruiting now · Not applicable

Conditions studied: Cervical Cancer, Chemoradiotherapy, Immunotherapy

In brief

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.

Key facts

Study ID

NCT06256224

Run by

Ruijin Hospital

People needed

150

Starts

2024-02-02

Expected to finish

2028-12-31

Last updated by the study team

2024-04-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ruijin Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.