Toripalimab Combined With Definitive CCRT for LACC Patients

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 Criteria:

* 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 Criteria:

* 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

Conditions4

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