Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The prognosis was poor for recurrent, metastasis and persistent cervical cancer especially for those who had multiple lesions and history of previous radiation therapy. KEYNOTE-826 Study demonstrated survival benefit of adding pembrolizumab into the standard first-line treatment for cervical cancer. Here we designed a exploratory clinical study to test a new treatment combination including cadonilimab and anlotinib in recurrent, metastasis and persistent cervical cancer. All participants will receive cadonilimab of 10mg/kg every three weeks at day 1, take anlotinib (8mg) 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05817214
Study type	Interventional
Source	Zhongnan Hospital
Contact	Shaoxing Sun, M.D.
Phone	+08613871286154
Email	sunshaoxing@whu.edu.cn
Status	Recruiting
Phase	Phase 2
Start date	February 16, 2023
Completion date	February 28, 2027

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