Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06140589
Enrollment
200
Registered
2023-11-20
Start date
2024-09-07
Completion date
2026-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Cervical Cancer, immune checkpoint inhibitors, Curative effect, safety, cost-effectiveness analysis

Brief 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.

Detailed description

1. To explore the efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer. 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. 2. Observation on the safety and adverse reactions of Cadonilimab. Collect adverse events of tumors and abnormal laboratory indicators during medication (nausea, vomiting, bone marrow suppression, liver damage, rash, abnormal thyroid function, adrenocortical dysfunction, diabetes, myocarditis, myositis, hand-foot syndrome, etc.). 3. To explore the cost-benefit analysis of Cadonilimab in patients with cervical cancer. 4. Explore the relationship between genetic mutations and drug efficacy.

Interventions

DRUGCadonilimab

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

Sponsors

Fujian Medical University Affiliated Nanping First Hospital
CollaboratorUNKNOWN
The First Hospital Affiliated to Fujian Medical University
CollaboratorUNKNOWN
Fujian Medical University Union Hospital
CollaboratorOTHER
Gutian Hospital
CollaboratorUNKNOWN
Jiangxi Provincial Cancer Hospital
CollaboratorOTHER
Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan)
CollaboratorUNKNOWN
Lianyungang Donghai County People's Hospital
CollaboratorUNKNOWN
Changsha Maternal and Child Health Hospital
CollaboratorUNKNOWN
Pingxiang Maternal and Child Health Hospital
CollaboratorUNKNOWN
Huinan County People's Hospital
CollaboratorUNKNOWN
People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine
CollaboratorUNKNOWN
Fujian Cancer Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer2026-12-21Objective response rate (ORR) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced, recurrent or metastatic cervical cancer.

Secondary

MeasureTime frameDescription
Safety and adverse reactions of Cadonilimab2026-12-21According 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.
cost-effectiveness analysis of using Cadonilimab to treat cervical cancer2026-12-21The 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.
The relationship between genetic mutations and the efficacy of Cadonilimab A in patients with cervical cancer2026-12-21According 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.

Countries

China

Contacts

Primary ContactYang Sun, Master
doctorsunyang@sina.com15959028989
Backup ContactJian Chen
marsz3@126.com15806030009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026