An observational study in Small Cell Lung Cancer ( SCLC ) and Brain Injury, sponsored by Guizhou Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Guizhou Medical University · Observational
The study aims to enroll the small cell lung cancer(SCLC) who meet the indications for prophylactic cranial irradiation (PCI): patients with limited-stage SCLC who have achieved complete or partial remission after first-line treatment, or patients with extensive-stage SCLC whose tumors are effectively controlled after systemic therapy with no definitive evidence of brain metastases. Additional inclusion criteria are expected survival≥6 months, completion of at least 12 months of follow-up, and signed informed consent obtained before enrollment after explaining the study objectives and methods.The observation group consists of patients with extensive-stage SCLC receiving first-line chemotherapy combined with concurrent immunotherapy. After two cycles, patients with a confirmed response (CR, PR, or SD) undergo PCI. The control group consists of patients with limited-stage SCLC receiving standard concurrent chemoradiotherapy (systemic therapy plus thoracic radiotherapy). After two cycles of systemic therapy, those with a confirmed response undergo PCI.Starting from the completion of PCI, contrast-enhanced MRI of the brain (plain scan, contrast-enhanced scan, and DWI) and contrast-enhanced CT of the chest and whole abdomen are performed every three months. Treatment-related toxicity is evaluated using CTCAE v5.0. Cognitive function is assessed every three months using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA). Venous blood samples are collected one day before radiotherapy and every three months thereafter to measure white blood cells, neutrophils, lymphocytes, platelets, hemoglobin, liver function, renal function, electrolytes, and coagulation function; stool and urine tests are also performed. The data are analyzed to determine whether whole-brain radiotherapy combined with immunotherapy exacerbates neurological impairment.
1,240 studies on the registry are indexed under Small Cell Lung Carcinoma; 354 are open to participants now.
This study's planned enrollment of 42 is below the median of 144 across 126 observational studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Guizhou Medical University is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Histologically or cytologically confirmed limited-stage or extensive-stage small cell lung cancer, and meeting the indications for prophylactic cranial irradiation (PCI).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Extensive-stage small cell lung cancer
Drug: PD-1 Inhibitor + Chemotherapy+PCI
Limited-stage small cell lung cancer
Drug: chemotherapy+PCI
Drug page: Immune checkpoint inhibitors
The study was retrospective and did not use interventional protocols. The recommended first-line treatment for patients with extensive-stage small cell lung cancer is PD-1 inhibitor combined with chemotherapy. Under the condition that brain metastases have been excluded after effective drug therapy, prophylactic cranial irradiation (PCI) may be performed.
The study was retrospective and did not use interventional protocols. For patients with limited-stage small cell lung cancer, the recommended first-line treatment is platinum-based cytotoxic chemotherapy, and prophylactic cranial irradiation (PCI) may be administered after achieving a response to drug therapy.
Progression-free survival (PFS)
Time frame: From enrollment to the end of treatment at 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Dec 2028, 30 months after the start.
Of 62 observational studies under Small Cell Lung Carcinoma, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 30. This study's planned 30 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Guizhou Medical University