Study on the Efficacy, Safety and Cost-effectiveness of Cadonilimab in the Treatment of Cervical Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• •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.

Locations
Other Locations
China
No. 420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province
RECRUITING
Fuzhou
Contact Information
Primary
Yang Sun, Master
doctorsunyang@sina.com
15959028989
Backup
Jian Chen
marsz3@126.com
15806030009
Time Frame
Start Date: 2024-09-07
Estimated Completion Date: 2026-12
Participants
Target number of participants: 200
Treatments
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.
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.
Sponsors
Collaborators: Jiangxi Provincial Cancer Hospital, Gutian Hospital, People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fujian Medical University Affiliated Nanping First Hospital, Pingxiang Maternal and Child Health Hospital, Fujian Medical University Union Hospital, Lianyungang Donghai County People's Hospital, Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan), Huinan County People's Hospital, Changsha Maternal and Child Health Hospital, The First Hospital Affiliated to Fujian Medical University
Leads: Fujian Cancer Hospital

This content was sourced from clinicaltrials.gov