Toripalimab Combined With Definitive CCRT for LACC Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toripalimab, CCRT.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Chemoradiotherapy, Immunotherapy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Toripalimab Combined With Definitive Chemoradiotherapy for Locally Advanced Cervical Squamous Cell Carcinoma Patients
Overview
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.
Interventions
- Drug Toripalimab
Toripalimab combined with CCRT - Radiation 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)
Primary outcome measures
- 2-year progression-free survival [Time frame: 2 year]
Secondary outcome measures (3)
- 2-year local control [Time frame: 2 year]
- 2-year local regional control [Time frame: 2 year]
- 2-year overall survival [Time frame: 2 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital — Shanghai
Identifiers
NCT: NCT06256224 · 2024（022）