The Study of Apatinib Plus CIK as the Third Line Therapy... | NCT02493582

Studies
The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR

NCT02493582

Sponsor

The First People's Hospital of Changzhou

Status

Active, not recruiting

Last Update Posted

Feb 5, 2016Estimated

Enrollment

400Estimated

Phase

Phase 2

Conditions

Adenocarcinoma of Lung

Interventions

Cytokine-Induced Killer Cells
Apatinib

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jul 2030Estimated

Completion Date

Jul 2033Estimated

First Submitted Date

Jul 7, 2015

First Submission Date that Met QC Criteria

Jul 8, 2015

First Posted Date

Jul 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2016

Last Update Posted Date

Feb 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced lung adenocarcinoma patients with wild-type EGFR

Detailed Description

400 patients with stage IIIB & IV lung adenocarcinoma who had received surgery and chemotherapy,will be randomly divided into group A（Apatinib plus CIK treatment ) or group B（Apatinib), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Apatinib alone	Other	Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.	Drug: Apatinib
Apatinib+CIK	Experimental	Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.	Biological: Cytokine-Induced Killer Cells Drug: Apatinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytokine-Induced Killer Cells	Biological	CIKs are used with Apatinib to treat lung adenocarcinoma patients with wild-type EGFR	Apatinib+CIK

Measure	Description	Time Frame
Overall Survival (OS)		3 months

Measure	Description	Time Frame
Progression-Free-Survival (PFS)		3 months

Measure	Description	Time Frame
Number of participants with Adverse events		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed Lung adenocarcinoma
Wld-type EGFR
Stage IIIB/IV
Failure to prior chemotherapy
Life expectancy of more than 3 months
Tissue sample desired for genomic study
Age ≥ 18 years
Performance status (WHO) < 3
Adequate bone marrow function (absolute neutrophil count>1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
Informed consent

Exclusion Criteria:

Lung squamous cell carcinoma or other types of Non-Small cell lung cancer
Small cell lung cancer
Have previously received TKIs
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
Pregnant or lactating patients
Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
Patients who are suffering from serious autoimmune disease
Patients who had used long time or are using immunosuppressant
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type