NCT06047860

A Clinical Study of Recombinant Human Vascular Endothelial Inhibitor in Combination With PRaG for Advanced Refractory Non-small Cell Lung Cancer

A Clinical Study of Recombinant Human Vascular Endothelial Inhibitor (Endo) in Combination With Bragg Treatment for Advanced Refractory Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Exploring the efficacy and safety of recombinant human vascular endothelial inhibitor (Endo) in combination with Bragg therapy in advanced refractory non-small cell lung

Detailed description

Radiotherapy: Start radiotherapy on the first day of treatment, as described in 6.2 above; GM-CSF treatment: GM-CSF 200 μg on the first day of treatment, administered subcutaneously daily for 7 days; IL-2 treatment. 2 million IU of IL-2 on the day after GM-CSF, administered subcutaneously daily for 7 days; Immunotherapy: PD-1/PD-L1 inhibitors within one week of radiotherapy; Recombinant human vascular endothelial inhibitor (Endo): Recombinant human vascular endothelial inhibitor (Endo) 210 mg CIV72h starting on the first day of treatment, every 21 days for a minimum of ≥ 2 cycles of this combination therapy. Maintenance treatment phase: Maintenance with PD-1/PD-L1 inhibitor in combination with recombinant human vascular endothelial inhibitor (Endo) until progression or intolerable side effects.

Conditions

• Advanced Solid Tumor
• Refractory Tumor

Interventions

Type	Name	Description
RADIATION	Radiotherapy	hypofractionated radiotherapy/SBRT
DRUG	PD-1/PD-L1 inhibitor	PD-1/PD-L1 inhibitor within one week of radiotherapy
DRUG	Granulocyte-macrophage colony-stimulating factor subcutaneous injection	IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;
DRUG	Interleukin 2 subcutaneous injection	IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;
DRUG	Endostatin	Recombinant human vascular endothelial inhibitor (Endo) 210 mg CIV72h was started on the first day of treatment, every 21 days for a minimum of ≥ 2 cycles of this combination therapy.

Timeline

• Start date: 2023-06-16
• Primary completion: 2024-12-30
• Completion: 2024-12-31
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: China