Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer

Shanxi Province Cancer Hospital

Status and phase: Unknown; Phase 2

Conditions: Brain Metastases

Treatments: Combination Product: Apatinib plus radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03356600

Ahead-SXZL 7

Details and patient eligibility

About

To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 to 75 years old, males or females;.

2. According to pathological and histological，the subjects were diagnosed with wild-type non-small-cell lung cancer patients from brain metastasis examinations;

3. Subjects failed first-line standard chemotherapy ;

4. Subjects expected survival of more than 3 months;

5. Eastern Cooperative Oncology Group performance status :0-2 points;

6. The main organ function is normal, that is to meet the following standards:(1) Blood routine examination meets the following standards

   a. Hemoglobin ≥90 g/L；b. Absolute Neutrophil Count≥1.5×10^9/L； c. Platelet ≥80×10^9/L； (2)Blood biochemistry examination meets the following standards

   a.Total Bilirubin <1.5 times the upper normal limit；b.Glutamic transaminase <2.5 times the upper normal limit, glutamic-oxalacetic transaminase <2.5 times the upper normal limit， For patients with liver metastasis ,the Glutamic transaminase and glutamic-oxalacetic transaminase index is less than 5 times the upper normal limit c.Serum Cr was less than 1.25 times the upper normal limit

7. Women of reproductive age must undergo urine tests to eliminate the possibility of pregnancy.During the period of treatment and within 8 weeks after the treatment, the subjects voluntarily adopted appropriate methods of contraception .

8. Subjects volunteered to participate in this study and signed informed consent

Exclusion criteria

1. Patients with meningeal metastasis;
2. Patients with intracranial stroke;
3. Previous toxicity associated with chemotherapy and / or radiotherapy persisted;
4. Radiological evidence indicates the presence of an empty or necrotic tumor;
5. Radiological evidence indicates the presence of a central tumor invading large blood vessels;
6. Patients need to be treated with anticoagulants or antiplatelet drugs;
7. The subjects with abnormal coagulation function and bleeding tendency (INR>1.5×ULN、APTT>1.5×ULN);during the past 6 months, the subjects experienced severe thrombosis or clinically related severe bleeding events;In the past 3 months, clinically significant hemoptysis occurred;the subjects had inherited bleeding or thrombosis tendency;
8. Subjects with high blood pressure and whose blood pressure can not be reduced to normal range by antihypertensive drugs;
9. Other investigators believe that patients are not eligible for inclusion

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Apatinib plus radiotherapy

Experimental group

Description:

Apatinib: Within 1 week before radiotherapy, the dose of Apatinib were 500mg/daily .During radiotherapy,the dose of Apatinib were 250mg/daily. After radiotherapy, if the subject did not have a level 3 or above adverse reaction, investigators consider increasing doses to 500mg. Radiotherapy: The subjects with 1 to 4 metastases receive stereotactic radiosurgery or stereotactic radiation therapy ,and the subjects with more than 4 metastases receive stereotactic radiosurgery plus whole-brain radiation therapy.

Treatment:

Combination Product: Apatinib plus radiotherapy