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

NCT ID: NCT03129698

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-11

Study Completion Date

2020-03-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Apatinib in Maintenance Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients with untreated extensive-stage small-cell lung cancer
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Formerly Arm Label

Apatinib 250mg daily

Group Type OTHER

Apatinib

Intervention Type DRUG

Apatinib 250mg daily

Interventions

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Apatinib

Apatinib 250mg daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Junling Li

OTHER

Sponsor Role lead

Responsible Party

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Junling Li

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Junling Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Junling Li, doctor

Role: CONTACT

Phone: +86 13801178891

Email: [email protected]

Facility Contacts

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Junling Li, Doctor

Role: primary

Other Identifiers

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CH-L-066-SL

Identifier Type: -

Identifier Source: org_study_id