Spatial Fragmentation Combined With Low-dose Radiotherapy for Immunotherapy Combined With Chemotherapy-resistant Locally Advanced or Advanced Non-small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital

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

Qualifiers

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

Treatments tested in this trial

  • Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy
  • Conventional fractionated radiotherapy

Treatment groups

84 Participants
are divided into 2 treatment groups