Evaluating Cadonilimab for Cervical Cancer Treatment
Study on the Efficacy, Safety and Cost-effectiveness of Cadonilimab in the Treatment of Cervical Cancer
This study is testing a new drug called Cadonilimab to see if it can help people with persistent, recurrent, or metastatic cervical cancer feel better and live longer while also looking at its safety and costs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Fujian Cancer Hospital Government |
| Drugs / interventions | Cadonilimab, chemotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06140589 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy, safety, and cost-effectiveness of Cadonilimab, a PD-1/CTLA-4 bi-specific antibody, in patients with persistent, recurrent, or metastatic cervical cancer. It involves collecting clinicopathological data and medical imaging results to assess treatment outcomes based on RECIST criteria. Additionally, the study monitors adverse events and laboratory test results to evaluate safety, while also conducting a survival benefit analysis related to medical expenses. The research aims to explore the relationship between genetic mutations and the drug's efficacy.
Who should consider this trial
Good fit: Ideal candidates include individuals with persistent, recurrent, or metastatic cervical cancer who have specific pathological types and measurable lesions.
Not a fit: Patients with other histopathological types of cervical cancer or those who have previously received immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced cervical cancer.
How similar studies have performed: Other studies have shown promise with immune checkpoint inhibitors in treating various cancers, suggesting potential success for this approach in cervical cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * •Persistent, recurrent or metastatic cervical cancer; * The pathological types are squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma; * No combination with other multiple primary cancers; * MRI before treatment Or CT examination, according to RECIST evaluation standards, there is at least one measurable lesion; * ECOG score 0-1 points. * Subjects gave informed consent, voluntarily cooperated with clinical follow-up, and signed informed consent forms. Exclusion Criteria: * Patients with other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc.; * Previous treatment with immune checkpoint inhibitors; * There are drug contraindications, such as liver function Insufficiency, renal insufficiency, etc. * The patient withdraws the informed consent; * The researcher determines that the patient is not suitable to participate in this clinical study.
Where this trial is running
Fuzhou, Fujian
- No. 420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Yang Sun, Master
- Email: doctorsunyang@sina.com
- Phone: 15959028989
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.