Trial Title:
Exploring the Efficacy, Safety and Cost-effectiveness Analysis of Cadonilimab in the Treatment of Cervical Cancer
NCT ID:
NCT06140589
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Cervical Cancer
immune checkpoint inhibitors
Curative effect
safety
cost-effectiveness analysis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
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
Arm group label:
effective group
Arm group label:
ineffective group
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.
Criteria for eligibility:
Study pop:
Patients with advanced or metastatic cervical cancer who were treated from June 2022 to
December 2026 and met the above inclusion and exclusion criteria
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
No. 420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province
Address:
City:
Fuzhou
Zip:
350074
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Chen, Master
Phone:
+8615806030009
Email:
marsz3@126.com
Contact backup:
Last name:
Yang Sun, Master
Phone:
+8615959028989
Email:
sunyangfjzl@sina.com
Start date:
September 7, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Medical University Affiliated Nanping First Hospital
Agency class:
Other
Collaborator:
Agency:
The First Hospital Affiliated to Fujian Medical University
Agency class:
Other
Collaborator:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Collaborator:
Agency:
Gutian Hospital
Agency class:
Other
Collaborator:
Agency:
Jiangxi Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan)
Agency class:
Other
Collaborator:
Agency:
Lianyungang Donghai County People's Hospital
Agency class:
Other
Collaborator:
Agency:
Changsha Maternal and Child Health Hospital
Agency class:
Other
Collaborator:
Agency:
Pingxiang Maternal and Child Health Hospital
Agency class:
Other
Collaborator:
Agency:
Huinan County People's Hospital
Agency class:
Other
Collaborator:
Agency:
People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06140589
