NCT06243003 WBRT With Hippocampal-avoidance Technique Followed by SRT for Extensive-stage SCLC With Baseline Brain Metastases
| NCT ID | NCT06243003 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Fudan University |
| Condition | SCLC,Extensive Stage |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 56 participants in total. It began in 2024-01-15 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the safety and efficacy of hippocampal-sparing WBRT combined with SRS as first-line treatment for SCLC patients with brain metastases.
Eligibility Criteria
Inclusion Criteria: 1. Eastern Cooperative Oncology Group(ECOG) performance status score 0-2; 2. Small cell lung cancer confirmed by histopathology or cytology; 3. Complete baseline imaging data (including brain enhanced MRI/CT, positron emission tomography(PET/CT) or chest enhanced CT+ bone scan + neck and abdomen B ultrasound /CT) should be obtained before first-line treatment; 4. Patients with initial diagnosis of ES-SCLC with brain metastases who planned to receive at least 4 cycles of standard platinum-based doublet chemotherapy combined with immunotherapy (PD-1 or PD-L1 monoclonal antibody) as first-line treatment, and who met the organ function requirements as judged by the investigator; 5. Brain metastases assessed by contrast-enhanced MRI met the criteria for SRS (less than or equal to 10 brain metastases, maximum tumor volume less than 10ml, maximum tumor diameter less than 3cm, total tumor volume less than 15ml, and no evidence of leptomeningeal metastasis). 6. No history of other malignant tumors; 7. Male/female of childbearing age agreed to use contraception (surgical ligation or oral contraceptive/intrauterine device + condom) during the trial; 8. Life expectancy ≥3 months 9. Patients must be able to understand and voluntarily sign informed consent. Exclusion Criteria: 1. Patients with non-small cell lung cancer (NSCLC) components on baseline pathological examination; 2. Patients who had received any antitumor therapy prior to ES-SCLC diagnosis; 3. Patients with imaging evidence of leptomeningeal metastasis or suspected leptomeningeal metastasis with symptoms and signs; 4. patients unable to undergo contrast-enhanced MRI; 5. Patients with severe symptoms of brain metastases requiring emergency surgery to reduce intracranial pressure; 6. Patients who could not complete immobilization for radiotherapy or tolerate radiotherapy; 7. Symptomatic interstitial lung disease or active infectious/noninfectious pneumonia; 8. Patients requiring long-term corticosteroid or immunosuppressive therapy; 9. Patients who are allergic to PD-1 or PD-L1 monoclonal antibody immunotherapy or unable to receive immune maintenance therapy for other reasons; 10. Lactating or pregnant women; 11. The patient had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc. 12. Medical examination or clinical findings or other uncontrollable conditions that the investigator considers may interfere with the results or increase the risk of treatment complications for the patient; 13. Patients with mental illness, substance abuse, or social problems that could affect adherence were excluded from enrollment after physician review.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06243003 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying SCLC,Extensive Stage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06243003 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06243003 currently recruiting?
Yes, NCT06243003 is actively recruiting participants. Contact the research team at fuscczzf@163.com for enrollment information.
Where is the NCT06243003 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06243003 clinical trial?
NCT06243003 is sponsored by Fudan University. The trial plans to enroll 56 participants.