RecruitingNot ApplicableNCT06256224

Toripalimab Combined With Definitive CCRT for LACC Patients

Toripalimab Combined With Definitive Chemoradiotherapy for Locally Advanced Cervical Squamous Cell Carcinoma Patients

Sponsor

Ruijin Hospital

Enrollment

150 participants

Start Date

Feb 2, 2024

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer Immunotherapy Chemoradiotherapy

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial adds toripalimab (an immunotherapy drug that blocks the PD-1 checkpoint to help the immune system fight cancer) to standard chemoradiation treatment for women with locally advanced cervical cancer. The goal is to see if combining immunotherapy with the standard approach achieves better cancer control. **You may be eligible if...** - You are a woman over 18 with newly diagnosed locally advanced squamous cell cervical cancer - Your tumor is FIGO stage IB3 to IVA (moderately to very advanced but not yet spread to distant organs) - You have not received any prior treatment for this cancer - You are in good health (ECOG status 0–1) with no major organ failure **You may NOT be eligible if...** - You have a history of immune deficiency disorders - You have previously received PD-1 or PD-L1 immunotherapy - You have another condition that the researchers believe would increase treatment risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab

Toripalimab combined with CCRT

RADIATIONCCRT

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)