Antirotinib Hydrochloride Plus Whole Brain Radiotherapy for Small Cell Lung Cancer With Brain Metastases

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Antirotinib Hydrochloride Plus Whole Brain Radiotherapy for Small Cell Lung Cancer With Brain Metastases

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06611657
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lei Deng, MD
Principal Investigator Affiliation	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Whole Brain Radiotherapy

Additional Details

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.

Arms & Interventions

Arms

Experimental: Anlotinib hydrochloride

Subjects received antirotinib hydrochloride capsules, 1 capsule (12mg) once a day.

Interventions

Drug: - Antirotinib hydrochloride

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Address

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing, 100021

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