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Clinical Trial Summary

The goal of this multicenter prospective single-arm phase I/II study is to study the safety and efficacy stereotactic body radiotherapy (SBRT) combined with Cadonilimab for advanced refractory malignant solid tumors. The main questions it aims to answer are: - How safe is this regimen of SBRT combined with Cadonilimab for advanced refractory malignant solid tumors? - How effective is this regimen of SBRT combined with Cadonilimab for advanced refractory malignant solid tumors? Participants will receive SBRT combined with Cadonilimab until disease progression or intolerable toxicities or death.


Clinical Trial Description

The goal of this single center prospective single-arm phase I/II study is to study the safety and efficacy stereotactic body radiotherapy (SBRT) combined with Cadonilimab for advanced refractory malignant solid tumors. The primary endpoint is adverse event (AE) and the secondary endpoints are progression free survival, overall survival, overall response rate, and disease control rate. Participants will receive SBRT combined with Cadonilimab. Cadonilimab will be administered, 6mg/kg, twice a week, intravenous until disease progression or intolerable toxicities or death. The first cycle of Cadonilimab was started within 3 days before and after the first fraction of SBRT treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05915481
Study type Interventional
Source Peking University Third Hospital
Contact Hongqing Zhuang, M.D.
Phone 8601082264910
Email hongqingzhuang@163.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date June 21, 2023
Completion date June 21, 2025

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