NCT05790447

Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors

Treatment of Advanced Refractory Solid Tumors Based on Precise Thymalfasin-regulated PRaG Mode: an Open-label, Prospective, Multicenter Study (PRaG 5.0 Study)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, Phase II investigator-initiated trial of precise thymalfasin-regulated therapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF for treatment of advanced refractory solid tumors.

Detailed description

One cycle of activation cycle includes： Loading dose with thymalfasin was administrated based on the absolute number of T lymphocytes. Radiotherapy (5 or 8Gy three fractions)was administrated to a metastatic lesion. GM-CSF 200ug was subcutaneous injected for seven days from the first day of radiotherapy PD-1/L1 inhibitor was intravenous injected within one week after radiotherapy. At least two activation cycles were administrated. Then maintenance treatment includes： Loading dose with thymalfasin was administrated based on the absolute number of T lymphocytes. GM-CSF 200ug was subcutaneous injected for seven days. PD-1/L1 inhibitor was intravenous injected.

Conditions

• Advanced Solid Tumor
• Refractory Tumor

Interventions

Type	Name	Description
DRUG	Thymalfasin	loading dose with thymalfasin based on the amounts of T lymphocyte
RADIATION	Radiotherapy	hypofractionated radiotherapy/SBRT
DRUG	PD-1/PD-L1 inhibitor	The PD-1/PD-L1 inhibitors are used within one week after radiotherapy
DRUG	GM-CSF	subcutaneous injection daily for 7 consecutive days

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-05-01
• Completion: 2025-12-01
• First posted: 2023-03-30
• Last updated: 2023-03-30

Locations

1 site across 1 country: China