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

Junling Li

Status and phase

Unknown

Phase 2

Conditions

Apatinib in Maintenance Treatment

Treatments

Drug: Apatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT03129698

CH-L-066-SL

Details and patient eligibility

About

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

Full description

52 patients with extensive-stage small-cell lung cancer, who had a best response of complete response (CR), partial response (PR), or stable disease (SD) after completing chemotherapy will receive apatinib monotherapy as maintenance therapy after chemotherapy to evaluate the efficacy and safety of maintenance apatinib after chemotherapy for small-cell lung cancer. At the same time, we will explore the correlation between efficacy and tumor stem cell markers expression by taking peripheral blood to detect tumor stem cell markers. The primary end point is progression-free survival (PFS). The secondary end point is overall survival (OS), toxicity, and the correlation between efficacy and tumor stem cell markers expression.

Enrollment

52 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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