NCT05754203

Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With ICIs for Advanced NSCLC

Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint Inhibitor for Advanced Non-small Cell Lung Cancer.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Investigators intend to combine low-dose hypersensitivity with high-dose immunopotentiation effect, and use super-hyperfractionation pulse radiotherapy, which is expected to achieve the effect of in situ vaccine that can enhance tumor killing, protect normal tissues, reduce immune cell damage and enhance tumor immunogenicity at the same time, and play a stronger immunopotentiation effect in combined immunotherapy. Thereby inducing a stronger abscopal effect of radiotherapy.

Conditions

• Lung Cancer
• Immune Checkpoint Inhibitor
• Radiotherapy

Interventions

Type	Name	Description
RADIATION	Super-hyperfractionation Pulse Radiotherapy	Radiotherapy design: a single dose of 0.5Gy, 16 consecutive pulses with an interval of 3 minutes (0.5Gy \* 16F), total dose DT: 8Gy; Immunotherapy: PD-1/PD-L1 monoclonal antibodies conforming to CSCO guidelines for lung cancer indications, including Carrilizumab, Tirelizumab, Teripril, Paborizumab, etc., conventional therapeutic dose, Q3W, until progression or the investigator judges that there is no longer clinical benefit or intolerable side effects.

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-03-03
• Last updated: 2025-07-14

Locations

2 sites across 1 country: China