Health TrialsbyHealthPanel

SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer

ConditionsNon-Small-Cell Lung CancerBrain Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First People's Hospital of Lianyungang

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with diffuse pleural metastases, malignant pericardial effusion, or diffuse spinal cord involvement.

Patients with a history of other malignancies within 5 years (excluding cured basal cell carcinoma of the skin, prostate intraepithelial neoplasia, and cervical intraepithelial neoplasia).

Current presence of pulmonary pneumonia with CTCAE 5.0 grade ≥ 2.

Individuals with various factors that affect oral medication (such as dysphagia, gastrointestinal resection, chronic diarrhea, and intestinal obstruction).

Trial design

Design model

Single group

Treatments tested in this trial

  • Anlotinib hydrochloride

    Drug

    Anlotinib#12mg#PO#Q3W#d1-14# SRT#depends

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Anlotinib+SRT GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

intracerebral Progression-Free-Surviva（iPFS）

The time from the start of treatment to intracranial tumor progression or death for any reason The time from the start of treatment to intracranial tumor progression or death for any reason The time from the start of treatment to intracranial tumor progression or death for any reason

Time frame
20 months
2

intracerebral Objective Response Rate (iORR)

The proportion of patients whose intracranial tumor volume has reduced to a predetermined value and can maintain the minimum time limit

Time frame
20 months

Secondary outcomes

1

intracerebral Progression-Free-Survival rate at 6 months and 1 year

Time frame
12 months
2

Progression-Free-Survival（PFS）

Time frame
20 months
3

Objective Response Rate（ORR）

Time frame
20 months
4

intracerebral Disease Control Rate（iDCR）

Time frame
20 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First People's Hospital of Lianyungang

Lead sponsor

Source ClinicalTrials.gov
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