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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Active, not recruiting; Phase 2

Conditions: Whole Brain Radiotherapy

Treatments: Drug: Antirotinib hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06611657

NCC2766

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Anlotinib hydrochloride

Experimental group

Description:

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

Treatment:

Drug: Antirotinib hydrochloride