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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent.

• Participants diagnosed with stage IIIB or above non-small cell lung cancer confirmed by histopathology (whether newly diagnosed or not) meet the requirements of SBRT radiotherapy (mass limited, less than 5 cm) and immune checkpoint inhibitor therapy (according to CSCO guidelines).

• Age ≥ 18 and less than 75.

• Eastern Cooperative Oncology Group Performance Status Score (ECOG PS) 0-3.

Locations
Other Locations
China
Jianguo Sun
NOT_YET_RECRUITING
Chongqing
the second affiliated hospital of Army medical university
RECRUITING
Chongqing
Contact Information
Primary
Jianguo Sun, doctor
sunjianguo@tmmu.edu.cn
+862368774490
Backup
Lin-Peng Zheng
zlpxiangya@163.com
+862368774395
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 40
Treatments
Experimental: Super-hyperfractionation Pulse Radiotherapy Combined With Immune Checkpoint Inhibitor
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.
Sponsors
Leads: Xinqiao Hospital of Chongqing

This content was sourced from clinicaltrials.gov