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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-20

Study Completion Date

2025-07-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Whole Brain Radiotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anlotinib hydrochloride

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

Group Type EXPERIMENTAL

Antirotinib hydrochloride

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Anlotinib hydrochloride + Brain radiotherapy

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No