NCT06140589Recruiting
Exploring the Efficacy, Safety and Cost-effectiveness Analysis of Cadonilimab in the Treatment of Cervical Cancer
Study on the Efficacy, Safety and Cost-effectiveness of Cadonilimab in the Treatment of Cervical Cancer
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Cadonilimab, a PD-1/CTLA-4 bi-specific antibody, is being developed by Akeso, Inc. for the treatment of a range of solid tumors, including cervical cancer, lung cancer, gastric/gastroesophageal junction cancer, liver cancer and nasopharyngeal cancer. Cadonilimab was approved in China in June 2022 for use in patients with relapsed or metastatic cervical cancer who have progressed on or after platinum-based chemotherapy. The clinicopathological data of patients with persistent, recurrent or metastatic cervical cancer treated with Cadonilimab were collected, and medical images (magnetic resonance, CT, etc.) before and after treatment were followed up, and the efficacy was evaluated according to RECIST standards. The incidence and severity of adverse events and clinically significant abnormal laboratory test results were collected to evaluate the safety of the drug. Survival benefit analysis is conducted based on the patient's survival time and medical expenses.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 6 Nov 2023
- Start date
- 7 Sept 2024
- Primary completion date
- Dec 2024
- Lead sponsor
- Fujian Cancer Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT06140589
What you commit to
- Study type: Observational
- Planned participants: 200
- From 7 Sept 2024 to the primary completion date, Dec 2024
- 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
- 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.
Who the study is looking for
- •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.
Age in the registry: 18 years to 80 years · 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 |
|---|---|---|---|
| No. 420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.