Clinical trial · Interventional
The Efficacy and Safety of Apatinib Monotherapy in Maintenance Treatment of Extensive-stage Small-cell Lung Cancer
Phase II Study of Apatinib in Maintenance Treatment of Extensive-stage Small-cell Lung Cancer
NCT03129698CI-TRIAL-00027273unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
52 patients with extensive-stage small-cell lung cancer and without progression after completing chemotherapy, will receive apatinib monotherapy as maintenance therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Apatinib in Maintenance Treatment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Formerly Arm Label
- description
- Apatinib 250mg daily
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 6 months
Secondary outcomes (2)
- measure
- Number of participants with Adverse events
- timeFrame
- 6 months
- description
- Drug related side effects
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.