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
Fujian Cancer Hospital
200 participants
Sep 7, 2024
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- •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 Criteria5
- 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.
Interventions
The intravenous dose of Cadonilimab was 10mg/kg, and every 3 weeks was a course of treatment; Or 6mg/kg, every 2 weeks for a course of treatment
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06140589