Status:
ACTIVE_NOT_RECRUITING
Antirotinib Hydrochloride Plus Whole Brain Radiotherapy for Small Cell Lung Cancer With Brain Metastases
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Whole Brain Radiotherapy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The objective of this study was to evaluate the efficacy and safety of whole brain radiotherapy combined with antirotinib hydrochloride in the treatment of brain metastases in small cell lung cancer
Detailed Description
This was a single-center, single-arm trail. Enrolled patients were pathologically diagnosed with small cell lung cancer and had completed at least 4 cycles of first-line chemotherapy. Patients with br...
Eligibility Criteria
Inclusion
- Small cell lung cancer confirmed by pathology, completion of at least 4 cycles of first-line chemotherapy, and measurable disease according to RECIST criteria.
- The expected survival time is more than 3 months.
- Intracranial metastases ≤10.
- Adequate organ and bone marrow function.
Exclusion
- Patients who have used antiangiogenic drugs within the previous 1 month.
- Non-small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer).
- Small cell lung cancer with hilar invasion or hemoptysis.
- Patients with intracranial acute, subacute cerebral infarction, intracranial lesions acute, subacute hemorrhage.
- An unresolved acute toxic reaction period higher than grade 2 of CTC-AE(4.0) due to any prior treatment.
- Advanced patients with severe symptoms, tumors that have spread to the internal organs, and a short-term risk of life-threatening complications.
- Patients with life-threatening conditions of other severe and/or uncontrolled diseases.
Key Trial Info
Start Date :
August 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06611657
Start Date
August 20 2021
End Date
July 30 2025
Last Update
October 16 2024
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021