NCT07905937
Exploration of Whole-Brain Radiotherapy Combined With PD-1 Inhibitors on Brain Injury
Recruiting · Not specified · Guizhou Medical University · registry updated 2026-10-30
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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)....
Inclusion
- Histologically or cytologically confirmed limited-stage or extensive-stage small cell lung cancer, and meeting the indications for prophylactic cranial irradiation (PCI): patients with limited-stage disease achieving complete response (CR) or partial response (PR) after first-line treatment; patients with extensive-stage disease achieving effective tumor control after systemic therapy, with no clear evidence of brain metastasis.
- Age 18-75 years, Karnofsky Performance Status (KPS) score ≥ 70.
- Estimated survival ≥ 6 months, with completion of at least 12 months of follow-up.
- No contraindications to radiotherapy, chemotherapy, or immunotherapy.
- Good compliance with the treatment protocol and follow-up, and provision of informed consent.
Exclusion
- Patients with brain metastases, cerebral infarction, cerebral hemorrhage, sequelae of traumatic brain injury, or other primary brain diseases (e.g., Alzheimer's disease, multiple sclerosis) confirmed by MRI before enrollment.
- Patients who have previously received brain radiotherapy, brain surgery, or immunotherapy.
- Patients with psychiatric disorders or cognitive impairment (MMSE score \< 26) unable to cooperate with follow-up assessments.
- Patients with a history of other malignancies prior to or concurrent with the current treatment.
- Severe cardiac, pulmonary, or renal disease, active autoimmune disease, or uncontrolled active infectious disease.
- Pregnant or lactating women.