NCT04892498

Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors (PRaG2.0)

A Prospective Multicenter Clinical Study of Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective multicenter clinical study to determine the efficacy and safety of hypofractionated radiotherapy combined with PD-1 inhibitor sequential GM-CSF and IL-2 for advanced multiple metastatic solid tumors

Conditions

• Advanced Refractory Solid Tumors

Interventions

Type	Name	Description
RADIATION	Hypofractionated radiotherapy	10-24Gy/5-8Gy/2-3f
DRUG	PD-1 inhibitor	q3w, until PD
DRUG	GM-CSF	200μg, D1-D7, ≥8 cycles
DRUG	IL-2	at a dose of 2 million IU, D8-D14, ≥8 cycles

Timeline

• Start date: 2021-05-30
• Primary completion: 2023-08-01
• Completion: 2024-08-01
• First posted: 2021-05-19
• Last updated: 2022-08-09

Locations

16 sites across 1 country: China