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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06434740
Other study ID # SRRS-LCsbrt
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2024
Est. completion date December 30, 2027

Study information

Verified date May 2024
Source Sir Run Run Shaw Hospital
Contact Xiaonan Sun, Ph D
Phone 8613606618387
Email sunxiaonan@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy and safety of SBRT combined with Puterizumab immunotherapy for non-small cell lung cancer with pulmonary metastases, and to determine the correlation between MRD and treatment efficacy. Through single-cell sequencing and spatial transcriptome information analysis, the underlying mechanisms will be analyzed to provide a basis for improving the new precision treatment methods for tumor immunotherapy resistance.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 37
Est. completion date December 30, 2027
Est. primary completion date December 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. age=18 2. Non small cell lung cancer patients who have experienced pulmonary metastasis after PD-1 immunotherapy in the past 3. Voluntarily participate in this study and sign an informed consent form 4. The presence of evaluable size and number of pulmonary metastases on chest CT 5. There are indications for lung puncture biopsy 6. General physical condition (ECOG) 0-1 7. The laboratory test meets the following standards: white blood cell count>3.5 × 109/L, absolute value of neutrophils>1.8 × 109/L, platelet count = 75 × 109/L, hemoglobin = 100g/L; NR = 1.5, and APTT = 1.5 times the upper limit of normal value or partial prothrombin time (PT) = 1.5 times the upper limit of normal value; Total bilirubin = 1.25 times the upper limit of normal value; ALT and AST<5 times the upper limit of normal values; 24-hour creatinine clearance rate>50mL/min or blood creatinine<1.5 times the upper limit of normal value. Exclusion Criteria: 1. Unable to tolerate or refuse further immunotherapy 2. Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiteracy, etc

Study Design


Intervention

Radiation:
Stereotactic Body Radiation Therapy,SBRT
The enrolled subjects will receive SBRT treatment for lung metastases.The dose segmentation is 10Gy/f, with a total dose of 50Gy/5f, once every other day.
Drug:
Puterizumab
Within 7-14 days after SBRT, Puterizumab should be used (dosage: recommended dosage of 200mg, intravenous infusion, infusion time of 60 minutes (± 15 minutes), once every 3 weeks (Q3W), for 6-8 months or intolerable toxicity).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sir Run Run Shaw Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary tumor response rate The tumor response rate will evaluate the local control of lung metastases,referring to the evaluation criteria for solid tumor efficacy RECIST 1.1 From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
Secondary Minor Residual Lesions Using the minimal residual disease (MRD) panel for ctDNA molecular residual detection, and through ctDNA multi-node assessment, we can dynamically monitor the therapeutic efficacy and disease recurrence. From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
Secondary progression-free survival PFS is the time from enrollment to tumor progression or death. From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
Secondary overall survival OS is the time from enrollment to death due to any reason. From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
Secondary RTOG acute radiation injury grading Refer to the acute radiation injury grading standards of the United States Collaborative Group on Tumor Radiotherapy (RTOG) From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted during the entire SBRT process and monthly after SBRT for up to 12 months.
Secondary QLQ-30 score The quality of life will be evaluated using the QLQ-30 score. From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
Secondary Lymphocyte subpopulation analysis Using flow cytometry to detect the count and percentage of lymphocytes, including CD3+, CD3+, CD4+, CD3+, CD8+, CD4+/CD8+, and CD3-CD56+. From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
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