Actively Recruiting
Spatial Fragmentation Combined With Low-dose Radiotherapy for Immunotherapy Combined With Chemotherapy-resistant Locally Advanced or Advanced Non-small Cell Lung Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-06-17
84
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Spatial Fragmentation Combined With Low-dose Radiotherapy for Immunotherapy Combined With Chemotherapy-resistant Locally Advanced or Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- At least 18 years old
- Karnofsky Performance Status (KPS) score of 70 or higher
- Expected survival of more than 3 months
- Histopathological diagnosis of small cell lung cancer, lung adenocarcinoma, or lung squamous cell carcinoma
- Prior immunotherapy received with disease progression
- Radiotherapy target site not previously irradiated or irradiated at least 6 months ago
You will not qualify if you...
- Lesions unsuitable for radiotherapy such as malignant pleural effusion, ascites, or meningeal metastasis
- Serious comorbidities like recent myocardial infarction (within 6 months), severe arrhythmia, or mental illness preventing treatment completion
- Severe organ dysfunction including liver failure or cardiopulmonary failure
- Current severe infection
- Known or suspected active autoimmune diseases except vitiligo, cured childhood asthma, or well-controlled type 1 diabetes
- Experienced grade 3 or higher cardiac or liver toxicity or grade 4 toxicity in other organs during previous immunotherapy
- Other disqualifying conditions as determined by the study reviewers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
N
Ningbo Liu, doctor
CONTACT
N
Ningbo Liu, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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