The Efficacy and Safety of Apatinib Monotherapy in Maintenance Treatment of Extensive-stage Small-cell Lung Cancer

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

52 patients with extensive-stage small-cell lung cancer and without progression after completing chemotherapy, will receive apatinib monotherapy as maintenance therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Junling Li
• Treatments: Apatinib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed small-cell lung cancer and extensive stage (extrathoracic metastatic disease, malignant pleural effusion, contralateral supraclavicular adenopathy, or contralateral hilar adenopathy)

• Having a best response of complete response (CR), partial response (PR), or stable disease (SD) after completing chemotherapy, or combining sequential radiotherapy

• Prior treatment without c-kit targeted drugs

• Life expectancy of more than 3 months

• Age ≥ 18 years

• Oncology Group performance status of 0 to 2

• Informed consent.

Exclusion Criteria:

• Mixed lung cancer or other types of lung cancer

• Have previously received c-kit targeted drugs

• Hemoglobin<8.0 g/dL, white blood cell <3 X 10^9/L, platelet count <75 X 10^9/L, alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times

• Known or suspected allergy to the investigational agent or any agent given in association with this trial

• Patients had recent major surgery, significant hemoptysis ( 5 ml), open wounds, or brain metastases present on required pre-enrollment brain imaging or required full-dose anticoagulation

• Uncontrol hypertension, >160/100 mmHg after treatment

• Pregnant or lactating patients

• Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) infection

• Patients who are suffering from serious autoimmune disease

• Patients who had active infection

• Patients who are suffering from serious organ dysfunction

• Patients who are suffering from other cancer

• Other situations that the researchers considered unsuitable for this study.

• Other concurrent uncontrolled illness