NCT06434740Not yet recruitingPhase 2
A Study of SBRT Combined With Puterizumab in Intrapulmonary Metastasis From NSCLC
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
Source: ClinicalTrials.gov · Last updated 30 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- First submitted
- 19 May 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Sir Run Run Shaw Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06434740
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 37
- From 1 Jun 2024 to the primary completion date, 30 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable to tolerate or refuse further immunotherapy
Other illness
- Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiteracy, etc
Who the study is looking for
- age≥18
- Non small cell lung cancer patients who have experienced pulmonary metastasis after PD-1 immunotherapy in the past
- Voluntarily participate in this study and sign an informed consent form
- The presence of evaluable size and number of pulmonary metastases on chest CT
- There are indications for lung puncture biopsy
- General physical condition (ECOG) 0-1
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.