RecruitingNCT06140589

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

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


Sponsor

Fujian Cancer Hospital

Enrollment

200 participants

Start Date

Sep 7, 2024

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether cadonilimab — a newer immunotherapy drug that blocks two immune checkpoint proteins (PD-1 and CTLA-4) — is effective, safe, and cost-effective in treating persistent, recurrent, or metastatic cervical cancer. **You may be eligible if...** - You have persistent, recurrent, or metastatic cervical cancer - Your cancer is squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma - You have at least one tumor that can be measured on imaging (MRI or CT) - Your overall health is good (ECOG 0 or 1) - You do not have other primary cancers - You have signed informed consent **You may NOT be eligible if...** - Your cervical cancer is a rare type other than the three listed above - Your tumors cannot be measured on scans - You have another active cancer at the same time - Your overall health is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCadonilimab

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


Locations(1)

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

Fuzhou, Fujian, China

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NCT06140589


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