Clinical trial · Observational
Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in NSCLC
Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in Non-small Cell Lung Cancer
NCT04912128CI-TRIAL-00052091AnloSBRTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Anlotinib group
- description
- Patients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation,12mg/d QD,day1\~14, 21d/cycle. All patients received SBRT for brain metastases.
- interventionNames
- Drug: Anlotinib
- label
- SBRT group
- description
- Patients in SBRT group took no anti-angiogenic drugs. All patients received SBRT for brain metastases.
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 1 years
- description
- progression-free survival
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients pathologically diagnosed as non-small cell lung cancer, with brain metastases and measurable lesions; 2. Patients aged between 18 -80 years; with expected survival time\>3 months. 3. Patients with no more than 5 brain metastases 4. Patients with normal organ function within 7 days prior to treatment, the following criteria are met: 1. blood routine examination criteria : i) hemoglobin (HB) ≥90g/L; ii) absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥80×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min; Exclusion Criteria: 1. Patients who had previously used antiangiogenic agents within 1 month; 2. Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer); 3. Patient with lung squamous cell carcinoma that involved pulmonary hilar, or non-small cell lung cancer with hemoptysis; 4. Patients with cerebral infarction and cerebral hemorrhage; 5. Patients without perilesional edema; 6. Patients with more than grade 2 (NCI-CTCAE v4.0) acute toxicity reaction due to any previous treatment. 7. Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.); 8. Patients with visceral dissemination or severe symptoms, which could cause death in short term; 9. Patients with any other severe and/or uncontrolled disease; 10. Patients who received a surgery, a biopsy or a significant traumatic injury within 1 month; 11. Patients with any signs or medical history of bleeding, unhealed wounds, ulcers or fractures, regardless of the severity; 12. Patients underwent artery or venous thrombotic events within 2 months, such as deep vein thrombosis and pulmonary embolism; 13. Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders; 14. Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers;
References
Publications (0)
Data not yet available
No reference posted for this study.