Exploring the Efficacy, Safety and Cost-effectiveness Analysis of Cadonilimab in the Treatment of Cervical Cancer
NCT ID: NCT06140589
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
200 participants
OBSERVATIONAL
2024-09-07
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cadonilimab Plus Nab -Paclitaxel for Patients With Recurrent, or Metastatic Cervical Cancer Resistant to Immune Checkpoint Inhibitors
NCT05824494
Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer
NCT05817214
A Single-Arm, Phase II Clinical Trail of Cadonilimab Combined With Chemoradiotherapy in Oligometastatic Stage IVB Cervical Cancer
NCT06998394
A Prospective Real-world Study of Cadonilimab in Patients With Recurrent or Metastatic Cervical Cancer
NCT06155422
CNCMT：a Multi-center, Prospective, Single-arm Study
NCT06714084
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
80 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fujian Medical University Affiliated Nanping First Hospital
UNKNOWN
The First Hospital Affiliated to Fujian Medical University
UNKNOWN
Fujian Medical University Union Hospital
OTHER
Gutian Hospital
UNKNOWN
Jiangxi Provincial Cancer Hospital
OTHER
Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan)
UNKNOWN
Lianyungang Donghai County People's Hospital
UNKNOWN
Changsha Maternal and Child Health Hospital
UNKNOWN
Pingxiang Maternal and Child Health Hospital
UNKNOWN
Huinan County People's Hospital
UNKNOWN
People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine
UNKNOWN
Fujian Cancer Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
No. 420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province
Fuzhou, Fujian, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Keam SJ. Cadonilimab: First Approval. Drugs. 2022 Aug;82(12):1333-1339. doi: 10.1007/s40265-022-01761-9.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Sunyang1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.