NCT05915481

Stereotactic Body Radiotherapy Combined With Cadonilimab for Advanced Refractory Malignant Solid Tumors

Clinical Study of Stereotactic Body Radiotherapy Combined With Cadonilimab for the Treatment of Advanced Refractory Malignant Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Solid Tumor
• Stereotactic Body Radiotherapy
• Immune Checkpoint Inhibitor
• Safety
• Efficacy

Interventions

Type	Name	Description
DRUG	Cadonilimab	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.
RADIATION	Stereotactic body radiotherapy	Participants will receive SBRT to one lesion or more lesions.

Timeline

• Start date: 2023-06-21
• Primary completion: 2024-06-21
• Completion: 2025-06-21
• First posted: 2023-06-23
• Last updated: 2023-06-23

Locations

1 site across 1 country: China