Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06256224

Toripalimab Combined With Definitive CCRT for LACC Patients

Led by Ruijin Hospital · Updated on 2024-04-24

150

Participants Needed

1

Research Sites

256 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Toripalimab Combined With Definitive CCRT for LACC Patients

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged over 18 years
  • Newly diagnosed and previously untreated locally advanced squamous cell carcinoma of the uterine cervix
  • FIGO 2018 stage IB3 to IVA with no distant metastasis
  • ECOG performance status 0-1 without major organ failure
  • Voluntary signed informed consent
Not Eligible

You will not qualify if you...

  • History of immunodeficiency disorders
  • Any condition that may increase the risk of treatment as judged by researchers
  • Previously received or currently receiving PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ruijin Hospital

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

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Research Team

D

Dan Ou

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Toripalimab Combined With Definitive CCRT for LACC Patients | DecenTrialz