Search / Trial NCT06611657

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

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Sep 22, 2024

Trial Information

Current as of December 22, 2024

Active, not recruiting

Keywords

ClinConnect Summary

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.

Gender

ALL

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.

Trial Officials

Lei Deng, MD

Study Chair

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

About Cancer Institute And Hospital, Chinese Academy Of Medical Sciences

The Cancer Institute and Hospital of the Chinese Academy of Medical Sciences is a leading research and treatment center dedicated to advancing cancer care through innovative clinical trials and comprehensive patient services. As a prominent institution in oncology, it focuses on integrating cutting-edge research with clinical practice, fostering collaborations that enhance the understanding and treatment of various cancer types. The institute is committed to improving patient outcomes by exploring novel therapies, optimizing treatment protocols, and contributing to the global fight against cancer through rigorous scientific investigation and evidence-based practices.

Locations

Beijing, Beijing, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0