Clinical trial NCT06140589: Exploring the Efficacy, Safety and Cost-effectiveness Analysis of Cadonilimab in the Treatment of Cervical Cancer
Official title: Study on the Efficacy, Safety and Cost-effectiveness of Cadonilimab in the Treatment of Cervical Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Keywords: Cervical Cancer
immune checkpoint inhibitors
Curative effect
safety
cost-effectiveness analysis
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Fujian Medical University Affiliated Nanping First Hospital
name: The First Hospital Affiliated to Fujian Medical University
name: Fujian Medical University Union Hospital
name: Gutian Hospital
name: Jiangxi Provincial Cancer Hospital
name: Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan)
name: Lianyungang Donghai County People&amp;amp;amp;amp;amp;amp;amp;amp;#39;s Hospital
name: Changsha Maternal and Child Health Hospital
name: Pingxiang Maternal and Child Health Hospital
name: Huinan County People&amp;amp;amp;amp;amp;amp;amp;amp;#39;s Hospital
name: People&amp;amp;amp;amp;amp;amp;amp;#39;s Hospital Affiliated to Fujian University of Traditional Chinese Medicine
First posted: 2023-11-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced or metastatic cervical cancer who were treated from June 2022 to December 2026 and met the above inclusion and exclusion criteria

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer
timeFrame: 2026-12-21
measure: Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer
timeFrame: 2026-12-21
measure: Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer
timeFrame: 2026-12-21
measure: Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer
timeFrame: 2026-12-21
Secondary outcomes:
measure: Safety and adverse reactions of Cadonilimab
timeFrame: 2026-12-21
measure: cost-effectiveness analysis of using Cadonilimab to treat cervical cancer
timeFrame: 2026-12-21
measure: The relationship between genetic mutations and the efficacy of Cadonilimab A in patients with cervical cancer
timeFrame: 2026-12-21
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: No. 420 Fuma Road, Jin&#39;an District, Fuzhou City, Fujian Province
state: Fujian
Study officials:
References:
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citation: Frentzas S, Gan HK, Cosman R, Coward J, Tran B, Millward M, Zhou Y, Wang W, Xia D, Wang ZM, Li B, Xia M, Desai J. A phase 1a/1b first-in-human study (COMPASSION-01) evaluating cadonilimab in patients with advanced solid tumors. Cell Rep Med. 2023 Nov 21;4(11):101242. doi: 10.1016/j.xcrm.2023.101242. Epub 2023 Oct 17.
citation: Zhang T, Lin Y, Gao Q. Bispecific antibodies targeting immunomodulatory checkpoints for cancer therapy. Cancer Biol Med. 2023 Mar 24;20(3):181-95. doi: 10.20892/j.issn.2095-3941.2023.0002.