NCT06256224Recruiting
Toripalimab Combined With Definitive CCRT for LACC Patients
Toripalimab Combined With Definitive Chemoradiotherapy for Locally Advanced Cervical Squamous Cell Carcinoma Patients
Source: ClinicalTrials.gov · Last updated 24 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 5 Feb 2024
- Start date
- 2 Feb 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Ruijin Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT06256224
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 2 Feb 2024 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previously suffered from immunodeficiency disorders
- Previously received or currently receiving other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1
Other illness
- had any condition that researchers believed to be associated with increased risk of treatment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.