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NCT Number: NCT06140589

Exploring the Efficacy, Safety and Cost-effectiveness Analysis of Cadonilimab in the Treatment of Cervical Cancer

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

  • 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.

  • 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.).
  • To explore the cost-benefit analysis of Cadonilimab in patients with cervical cancer.
  • Explore the relationship between genetic mutations and drug efficacy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cadonilimab

Drug

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

Primary outcomes

  1. Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer

    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.

  2. Efficacy of Cadonilimab in the treatment of persistent, 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.

  3. Efficacy of Cadonilimab in the treatment of persistent, 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.

  4. Efficacy of Cadonilimab in the treatment of persistent, 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.

Secondary outcomes

  1. Safety and adverse reactions of Cadonilimab

    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.

  2. cost-effectiveness analysis of using Cadonilimab to treat cervical cancer

    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.

  3. The relationship between genetic mutations and the efficacy of Cadonilimab A in patients with cervical cancer

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Chen

CONTACT

[email protected]

15806030009

Yang Sun, Master

CONTACT

[email protected]

15959028989

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Collaborators

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

Registry information

Official study title

Study on the Efficacy, Safety and Cost-effectiveness of Cadonilimab in the Treatment of Cervical Cancer

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Nov 20, 2023
Registry last updated
Sep 19, 2024

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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