Non-Small Cell Lung Cancer (NSCLC) Clinical Trials
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A Single-centre Phase II Clinical Study of Spatially Fragmentation Radiotherapy Combined With Low-dose Radiotherapy for Reversal of Immunotherapy Combined With Chemotherapy Resistance in Locally Advanced Inoperable or Advanced Non-small Cell Lung Cancer
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
• Have received prior immunotherapy and experienced disease progression.
• The site targeted for radiotherapy has not been previously irradiated or it has been at least 6 months since the last radiotherapy.
Locations
Other Locations
China
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Contact Information
Primary
Ningbo Liu, doctor
liuningbo@tjmuch.com
+86 15602036608
Backup
Ningbo Liu, doctor
+8615602036608
Time Frame
Start Date:2024-10-01
Estimated Completion Date:2028-01-28
Participants
Target number of participants:84
Treatments
Experimental: experimental group
1. Patients received dose-specific irradiation using a medical linear accelerator to create each sphere of approximately 0.5 to 1.5 cm in diameter within the gross tumour volume (GTV) of the largest tumour, with spheres spaced 2.0 to 5.0 cm apart from each other as the high-dose area; the rest of the GTV was used as the low-dose area.~ For a single lesion, spatially divided radiotherapy was given, with the prescribed dose for the high-dose area: 800-1200cGy×3f, and the prescribed dose for the low-dose area: 100-300cGy×5f; all the remaining irradiable metastatic foci were given low-dose radiotherapy (palliative radiotherapy was given to the brain and bone metastases in accordance with the clinical routine, and was excluded from the scope of low-dose radiotherapy), with the prescribed dos~2. During or within 1 week after radiotherapy, chemotherapy combined with immunotherapy was carried out according to the physical, pathological and genetic detection of the patients.
Active_comparator: control group
The control group only received conventional radiotherapy for chest or other lesions, followed by immunotherapy and chemotherapy according to the tumor stage, tolerance and genetic characteristics of the patients