drugset / Trial / NCT05817214

Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer

NCT05817214

NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to test a new treatment combination including cadonilimab, anlotinib and granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent, metastasis and persistent cervical cancer. The main questions it aims to answer are: * The efficacy of this combination in R/M/P CC; * The tolerance of this combination in R/M/P CC; * Possible biomarker of treatment response for this combination. Participants will receive cadonilimab of 10mg/kg every three weeks at day 1, take anlotinib (12mg) orally in day 1 to day 14, then take a 7 days break and subcutaneously injection of GM-CSF (200ug) from day 1 to day 14, then also take a 7-days break. This treatment will continue until progression or intolerable toxicity or withdraw of participants and it will last for no longer than 2 years.

Timeline

Start
2023-02-16
Primary completion
2025-11-30
Completion
2027-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Cadonilimab Monoclonal antibody 10 mg/kg
Subject Catequentinib Small molecule 12 mg Oral
Subject sargramostim Protein / enzyme biologic 200 ug Subcutaneous

Indications