NCT06256224 Toripalimab Combined With Definitive CCRT for LACC Patients
| NCT ID | NCT06256224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-02-02 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-02-02 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Haoping Xu
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT06256224 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06256224 currently recruiting?
Yes, NCT06256224 is actively recruiting participants. Contact the research team at od12341@rjh.com.cn for enrollment information.
Where is the NCT06256224 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06256224 clinical trial?
NCT06256224 is sponsored by Ruijin Hospital. The principal investigator is Haoping Xu at Ruijin Hospital. The trial plans to enroll 150 participants.
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