NCT07905937Recruiting
Exploration of Whole-Brain Radiotherapy Combined With PD-1 Inhibitors on Brain Injury
A Prospective Cohort Observational Study of Brain Injury Induced by Whole-Brain Radiotherapy Combined With Immunotherapy
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 42 (estimated)
- First submitted
- 20 Oct 2026
- Start date
- 30 Jun 2026
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Guizhou Medical University
- Diseases
- Lung cancer
- NCT number
- NCT07905937
What you commit to
- Study type: Observational
- Planned participants: 42
- From 30 Jun 2026 to the primary completion date, 30 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received brain radiotherapy, brain surgery, or immunotherapy.
Other illness
- 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 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.
Other
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.