Non-Small-Cell Lung Cancer Clinical Trial
Official title:
The Efficacy and Safety of Stereotactic Radiotherapy Combined With Puterizumab in Non Small Cell Lung Cancer With Intrapulmonary Metastasis:A Phase II Prospective Single Arm Clinical Study
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Sir Run Run Shaw Hospital |
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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