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

Overview

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

• Drug Cadonilimab
  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 outcome measures

• Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer [Time frame: 2026-12-21]
• Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer [Time frame: 2026-12-21]
• Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer [Time frame: 2026-12-21]
• Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer [Time frame: 2026-12-21]

Secondary outcome measures (3)

• Safety and adverse reactions of Cadonilimab [Time frame: 2026-12-21]
• cost-effectiveness analysis of using Cadonilimab to treat cervical cancer [Time frame: 2026-12-21]
• The relationship between genetic mutations and the efficacy of Cadonilimab A in patients with cervical cancer [Time frame: 2026-12-21]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• No. 420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province — Fuzhou

Publications

• Doroshow DB, Bhalla S, Beasley MB, Sholl LM, Kerr KM, Gnjatic S, Wistuba II, Rimm DL, Tsao MS, Hirsch FR. PD-L1 as a biomarker of response to immune-checkpoint inhibitors. Nat Rev Clin Oncol. 2021 Jun;18(6):345-362. doi: 10.1038/s41571-021-00473-5. Epub 2021 Feb 12. PMID 33580222
• Keam SJ. Cadonilimab: First Approval. Drugs. 2022 Aug;82(12):1333-1339. doi: 10.1007/s40265-022-01761-9. PMID 35986837
• Gao X, Xu N, Li Z, Shen L, Ji K, Zheng Z, Liu D, Lou H, Bai L, Liu T, Li Y, Li Y, Fan Q, Feng M, Zhong H, Huang Y, Lou G, Wang J, Lin X, Chen Y, An R, Li C, Zhou Q, Huang X, Guo Z, Wang S, Li G, Fei J, Zhu L, Zhu H, Li X, Li F, Liao S, Min Q, Tang L, Shan F, Gong J, Gao Y, Zhou J, Lu Z, Li X, Li J, Ren H, Liu X, Yang H, Li W, Song W, Wang ZM, Li B, Xia M, Wu X, Ji J. Safety and antitumour activity PMID 37797632
• 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. PMID 37852261
• 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. PMID 36971124
• Chen J, Yu H, Lin Y, Hu D, Liu L, Fan R, Zou J, Zang L, Lin Y, Lin R, Chen D, Weng X, Shen F, Wang S, Zeng W, Tian Q, Yi Y, Chen Y, Miao J, Zhang B, Zou Y, Gao F, Lian R, Yang L, Sun Y. Real-world data of cadonilimab in recurrent or metastatic cervical cancer in China: a multicentric study. Front Immunol. 2025 Jul 14;16:1611696. doi: 10.3389/fimmu.2025.1611696. eCollection 2025. PMID 40726978

Identifiers

NCT: NCT06140589 · Sunyang1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗