About this trial
The purpose of this study was to evaluate the effect of immunotherapy combined with spatial fractionation radiotherapy and low dose radiotherapy on the prognosis of patients with advanced lung cancer under specific dose regimens (spatial fractionation radiotherapy: high dose region: 800-1200cGy × 3f, low dose region: 100-300cGy × 5f; low dose radiotherapy area: 100-300cGy × 5f). Through the phase II clinical trial, to determine the efficacy and safety of the combined treatment model in advanced lung cancer and its effect on the immune microenvironment of patients, so as to provide scientific basis for the optimization of treatment regimen for advanced lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Sign the informed consent form.
Be at least 18 years old.
Have a Karnofsky Performance Status (KPS) score of 70 or higher and an expected survival of more than 3 months.
Have histopathological evidence of small cell lung cancer, lung adenocarcinoma, or lung squamous cell carcinoma.
Disqualifiers
The patient has lesions that are not suitable for radiotherapy: malignant pleural effusion, ascites, meningeal metastasis, etc.
The patient has other serious comorbidities, such as myocardial infarction occurring within 6 months, severe arrhythmia, mental illness, etc., is unable to complete the treatment, or has an expected survival period of less than 3 months.
The patient has severe organ dysfunction, such as liver failure, cardiopulmonary failure, etc., and is difficult to tolerate radiotherapy.
The patient currently has a severe infection.
Trial design
Parallel
Treatments tested in this trial
Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy
RadiationSpatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy
Conventional fractionated radiotherapy
RadiationConventional fractionated radiotherapy
Treatment groups
Trial outcomes
Primary outcomes
Objective response rate
Secondary outcomes
Disease control rate
Progression free survival
Overall survival
Adverse Event
Sponsors and contacts
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