Toripalimab Combined With Definitive CCRT for LACC Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Toripalimab: Toripalimab combined with CCRT

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)

Study 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

Primary outcome measure(s)

• 2-year progression-free survival — 2 year
  the date of the treatment to the date of disease progression or death from any cause in the absence of progression

Trial sites (1)

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