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Clinical Trials in China / NCT06140589
Recruiting Observational

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

NCT06140589 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Cancer Hospital
Phase
Observational
Started
2024-09-07
Last updated
2024-09-19

Condition(s) studied

Cervical Cancer

Investigational drug(s) / intervention(s)

Cadonilimab →

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

Study 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
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer — 2026-12-21
    Objective response rate (ORR) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced, recurrent or metastatic cervical cancer.
  • Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer — 2026-12-21
    Progression free survival (PFS) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced , recurrent or metastatic cervical cancer.
  • Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer — 2026-12-21
    Disease control rate (DFS) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced , recurrent or metastatic cervical cancer.
  • Efficacy of Cadonilimab in the treatment of persistent, recurrent or metastatic cervical cancer — 2026-12-21
    Overall survival (OS) was used to evaluate the efficacy of Cadonilimab in the treatment of advanced , recurrent or metastatic cervical cancer.

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06140589 on ClinicalTrials.gov ↗ ← All trials in China