Combining Toripalimab with Chemoradiotherapy for Cervical Cancer
Official title: Toripalimab Combined With Definitive Chemoradiotherapy for Locally Advanced Cervical Squamous Cell Carcinoma Patients
Run by Ruijin Hospital · NCT06256224 · Data updated 2026-11-12
This study is testing if adding an immunotherapy drug called toripalimab to standard treatment can help women with newly diagnosed locally advanced cervical cancer do better than with just the standard treatment alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | Toripalimab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | February 2, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | April 24, 2024 |
| Trial ID | NCT06256224 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women over 18 with newly diagnosed locally advanced squamous cell carcinoma of the cervix, specifically FIGO stages IB3 to IVA.
✕Probably not a fit
Patients with immunodeficiency disorders or those who have previously received PD-1 antibody treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of toripalimab, an immunotherapy drug, when combined with definitive chemoradiotherapy (CCRT) for women with newly diagnosed locally advanced cervical cancer. The study aims to compare the outcomes of patients receiving this combination treatment against those receiving CCRT alone. Participants must be female, aged over 18, and diagnosed with specific stages of cervical cancer without distant metastasis. The trial seeks to improve treatment options for patients who have a poor prognosis with standard therapies.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for women with locally advanced cervical cancer.
How similar studies have gone: Other studies have shown promising results with immunotherapy approaches in treating cervical cancer, suggesting potential success for this combination treatment.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Ruijin Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Haoping Xu — Ruijin Hospital
- Study coordinator: Dan Ou
- Email: od12341@rjh.com.cn
- Phone: 8618801970632
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.