SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer: a Single-arm, Prospective, Exploratory Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To evaluate the efficacy and safety of SRT combined with anlotinib in the treatment of limited brain metastases from non-small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
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• Patients voluntarily participate in this study, sign informed consent, and demonstrate good compliance.

• Patients with histologically or pathologically confirmed EGFR wild-type and EGFR mutant non-small cell lung cancer resistant to treatment.

• The number of brain metastases is ≤ 5, and the patient has at least one assessable brain metastasis on imaging (RECIST 1.1). Additionally, the patient's physical condition allows for the completion of stereotactic radiosurgery.

• Age between 18-80 years, gender unspecified.

• ECOG performance status of 0 or 1; expected survival of no less than 3 months.

• Regardless of prior treatment, it is only required that concurrent oral administration of anlotinib during radiotherapy without intervention regarding subsequent treatment regimens.

• Oral administration of anlotinib including, but not limited to, third-line therapy.

• Good function of major organs, with laboratory test indicators meeting the following criteria:

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• Hematological examination:

‣ Hemoglobin (Hb) ≥ 90g/L (no blood transfusion within 14 days);

⁃ Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; total white blood cell count ≥ 3.5×10\^9/L;

⁃ Platelets (PLT) ≥ 100×10\^9/L;

• Blood biochemistry examination:

• a、Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for liver metastasis/bone metastasis; ≤ 5 ULN for tumor bone metastasis); b、Total bilirubin (TBIL) ≤ 1.5 × ULN; c、Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate ≥ 60 ml/min;

• Coagulation function examination: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN.

Locations
Other Locations
China
The First People's Hospital of Lianyungang
RECRUITING
Lianyungang
Contact Information
Primary
Xiaodong Jiang, Doc
jxdysy1970@163.com
86-0518-85469074
Backup
Xiaodong Jiang, Doc
jxdysy1970@163.com
18961326201
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 46
Treatments
Experimental: Anlotinib+SRT Group
Anlotinib#12mg#PO#Q3W#d1-14#
Sponsors
Leads: The First People's Hospital of Lianyungang

This content was sourced from clinicaltrials.gov