No. 420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province
Fuzhou, Fujian, 350074, China
Location status: Recruiting
Location contact
Jian Chen, Master
CONTACT
Yang Sun, Master
CONTACT
NCT Number: NCT06140589
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.
Interested in participating?
Request Info18 year–80 year
Female
Observational
Fuzhou, Fujian, 350074, China
Location status: Recruiting
Jian Chen, Master
CONTACT
Yang Sun, Master
CONTACT
The size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. Complete response (CR) is defined as the complete disappearance of all target lesions. Partial response (PR): The sum of the diameters of all measurable target lesions is ≥30% below baseline. Disease progression (PD): The minimum value of the sum of the diameters of all measured target lesions during the entire experimental study is used as the reference, and the relative increase in the diameter sum is at least 20% (if the baseline measurement value is the smallest, the baseline value is used as the reference). Stable disease (SD): The reduction of the target lesion does not reach the PR level, and the increase does not reach the PD level, but is somewhere in between. For details, refer to the "Response Evaluation Criteria in Solid Tumors RECIST 1.1.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 2026-12-21
Objective response rate (ORR) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced, recurrent or metastatic cervical cancer.
Time frame: 2026-12-21
Progression free survival (PFS) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced , recurrent or metastatic cervical cancer.
Time frame: 2026-12-21
Disease control rate (DFS) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced , recurrent or metastatic cervical cancer.
Time frame: 2026-12-21
Overall survival (OS) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced , recurrent or metastatic cervical cancer.
Time frame: 2026-12-21
According to CTCAE v5.0, any adverse events that occur to all subjects during the study period will be recorded. We recorded the clinical manifestation characteristics, severity, onset time, duration, treatment method and prognosis, and determined the correlation with Cadonilimab.
Time frame: 2026-12-21
The main economic outcome is the ICER.Health benefits were expressed as life years (LYs), and quality-adjusted life-years (QALYs) gained. The ICER was calculated by dividing the incremental cost difference between the two strategies, by the incremental difference in health outcomes (LYs and QALYs). Probabilistic Sensitivity Analysis (PSA) was performed to assess the impact of uncertainty around the key parameters of the model on the ICER. A second-order Monte Carlo simulation with 1000 iterations was used to run replicated outcomes. The normal distributions used for costs, utility and reimbursement ratio were carried to the specific limits.
Time frame: 2026-12-21
According to the objective response rate, the patients in the study were divided into effective group and ineffective group. Whole exome sequencing was performed on some patients in the two groups to compare the differences in gene expression between the two group.
Contact information is provided by the study sponsor or research team.
Jian Chen
CONTACT
Yang Sun, Master
CONTACT
Fujian Cancer Hospital
Other Gov
Study on the Efficacy, Safety and Cost-effectiveness of Cadonilimab in the Treatment of Cervical Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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