Combining Toripalimab with Chemoradiotherapy for Cervical Cancer
Toripalimab Combined With Definitive Chemoradiotherapy for Locally Advanced Cervical Squamous Cell Carcinoma Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | Toripalimab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06256224 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with immunodeficiency disorders or those who have previously received PD-1 antibody treatments may not benefit from this study.
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 performed: Other studies have shown promising results with immunotherapy approaches in treating cervical cancer, suggesting potential success for this combination treatment.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.