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

Not Applicable

Recruiting

• Conditions: Immune Checkpoint Inhibitor; Radiotherapy; Lung Cancer
• Interventions: Radiation: Super-hyperfractionation Pulse Radiotherapy

• Registration Number: NCT05754203
• Lead Sponsor: Xinqiao Hospital of Chongqing

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-12
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-03
• Study Start: 2023-08-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint Inhibitor	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.

Primary Outcome Measures

Name	Time	Method
objective response rate	12 weeks	The proportion of patients with tumor volume reduced by 30% and maintained for more than 4 weeks. Sum of the proportions of complete response (CR) and partial response (PR)

Secondary Outcome Measures

Name	Time	Method
iORR	24 weeks	The objective response rate away from the radiation field

Trial Locations

Locations (2)

the second affiliated hospital of Army medical university; 🇨🇳 Chongqing, Chongqing, China

Jianguo Sun; 🇨🇳 Chongqing, China