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Trial Title:
Antirotinib Hydrochloride Plus Whole Brain Radiotherapy for Small Cell Lung Cancer With Brain Metastases
NCT ID:
NCT06611657
Condition:
Whole Brain Radiotherapy
Conditions: Official terms:
Small Cell Lung Carcinoma
Brain Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Antirotinib hydrochloride
Description:
Oral antirotinib treatment was started 2 weeks before radiotherapy for brain metastases,
stopped for 1 week after 2 weeks, and continued after radiotherapy until tumor
progression
Arm group label:
Anlotinib hydrochloride
Other name:
Anlotinib hydrochloride + Brain radiotherapy
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 brain metastases at first visit or during treatment were
treated with whole brain radiotherapy combined with anlotinib hydrochloride. Oral
antirotinib was started 2 weeks before radiotherapy for brain metastases and stopped for
1 week after 2 weeks. After radiotherapy, antirotinib was continued until tumor
progression. Efficacy and toxicity data were collected for evaluation and analysis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Small cell lung cancer confirmed by pathology, completion of at least 4 cycles of
first-line chemotherapy, and measurable disease according to RECIST criteria.
2. The expected survival time is more than 3 months.
3. Intracranial metastases ≤10.
4. Adequate organ and bone marrow function.
Exclusion Criteria:
1. Patients who have used antiangiogenic drugs within the previous 1 month.
2. Non-small cell lung cancer (including small cell carcinoma and non-small cell
carcinoma mixed lung cancer).
3. Small cell lung cancer with hilar invasion or hemoptysis.
4. Patients with intracranial acute, subacute cerebral infarction, intracranial lesions
acute, subacute hemorrhage.
5. An unresolved acute toxic reaction period higher than grade 2 of CTC-AE(4.0) due to
any prior treatment.
6. Advanced patients with severe symptoms, tumors that have spread to the internal
organs, and a short-term risk of life-threatening complications.
7. Patients with life-threatening conditions of other severe and/or uncontrolled
diseases.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Start date:
August 20, 2021
Completion date:
July 30, 2025
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06611657
