Apatinib in Maintenance Treatment Clinical Trial
Official title:
Phase II Study of Apatinib in Maintenance Treatment of Extensive-stage Small-cell Lung Cancer
52 patients with extensive-stage small-cell lung cancer and without progression after completing chemotherapy, will receive apatinib monotherapy as maintenance therapy.
| Status | Recruiting |
| Enrollment | 52 |
| Est. completion date | March 1, 2020 |
| Est. primary completion date | March 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Junling Li | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Junling Li |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | progression-free survival | 6 months | ||
| Secondary | Number of participants with Adverse events | Drug related side effects | 6 months | |
| Secondary | Overall Survival | 1 year |