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Cervical CancerNCT06140589

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

An observational study of Cervical Cancer, run by Fujian Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Cadonilimab
Type of treatment
Injection or infusion
How many people
200 participants
Where
1 siteChina
Study dates
7 Sep 2024to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • •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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yang Sun, Master contact

15959028989

doctorsunyang@sina.com

Jian Chen contact

15806030009

marsz3@126.com

China1 site, 1 recruiting
  • No. 420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province

    Fuzhou, Fujian, 350074

    Jian Chen, Master, +8615806030009, marsz3@126.com

    Yang Sun, Master, +8615959028989, sunyangfjzl@sina.com

    Recruiting

Other trials in China

About this study

Official title: Study on the Efficacy, Safety and Cost-effectiveness 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.

Read the 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.
Conditions
Cervical Cancer
Being tested
Cadonilimab
Keywords
Cervical Cancer, immune checkpoint inhibitors, Curative effect, safety, cost-effectiveness analysis
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CadonilimabDrug

    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

Study groups in NCT06140589
Study groupRoleWhat they receive
effective groupThe 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.
Receives: Drug: Cadonilimab
ineffective groupThe 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.
Receives: Drug: Cadonilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2026-12-21

  2. 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.

    Measured: 2026-12-21

  3. 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.

    Measured: 2026-12-21

  4. 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.

    Measured: 2026-12-21

Secondary outcomes (3)
  1. Safety and adverse reactions of Cadonilimab

    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.

    Measured: 2026-12-21

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

    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.

    Measured: 2026-12-21

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

    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.

    Measured: 2026-12-21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2023
  2. Study start7 Sep 2024 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06140589
Sponsor's protocol ID
Sunyang1
Status last verified
Nov 2023
First submitted
6 Nov 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All relevant patient personal information and follow-up results of this study were saved by the principal investigator, and there was no plan to share them with other investigators

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.

    PubMed 33580222
  • Keam SJ. Cadonilimab: First Approval. Drugs. 2022 Aug;82(12):1333-1339. doi: 10.1007/s40265-022-01761-9.

    PubMed 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 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 40726978

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Cancer, run by Fujian Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yang Sun, Master (15959028989, doctorsunyang@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer (time frame: 2026-12-21). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06140589, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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