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

NCT06140589 | Recruiting

• 1 other identifier: Sunyang1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

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

Outcome Measures

Primary Outcomes (4)

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

  Objective response rate (ORR) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced, recurrent or metastatic cervical cancer.

  2026-12-21

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

  Progression free survival (PFS) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced , recurrent or metastatic cervical cancer.

  2026-12-21

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

  Disease control rate (DFS) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced , recurrent or metastatic cervical cancer.

  2026-12-21

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

  Overall survival (OS) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced , recurrent or metastatic cervical cancer.

  2026-12-21

Secondary Outcomes (3)

• Safety and adverse reactions of Cadonilimab

  2026-12-21

• cost-effectiveness analysis of using Cadonilimab to treat cervical cancer

  2026-12-21

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

  2026-12-21

Study Arms (2)

effective group

The tumor size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. According to Recist 1.1 criteria, patients who were evaluated as complete remission, partial remission and stable disease were included in the effective group. Patients assessed as having progressive disease were included in the treatment-refractory group.

Drug: Cadonilimab

ineffective group

The tumor size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. According to Recist 1.1 criteria. Patients assessed as having progressive disease were included in the ineffective group.

Drug: Cadonilimab

Interventions

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

effective group; ineffective group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Fuzhou, Fujian, 350074, China

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• Keam SJ. Cadonilimab: First Approval. Drugs. 2022 Aug;82(12):1333-1339. doi: 10.1007/s40265-022-01761-9.

  PMID: 35986837 BACKGROUND

• 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 of cadonilimab, an anti-PD-1/CTLA-4 bispecific antibody, for patients with advanced solid tumours (COMPASSION-03): a multicentre, open-label, phase 1b/2 trial. Lancet Oncol. 2023 Oct;24(10):1134-1146. doi: 10.1016/S1470-2045(23)00411-4.

  PMID: 37797632 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Yang Sun, Master

CONTACT

15959028989; doctorsunyang@sina.com

Jian Chen

CONTACT

15806030009; marsz3@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 20, 2023
• Study Start: September 7, 2024
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)