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

Primary Purpose

Adenocarcinoma of Lung

Status

Active

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Cytokine-Induced Killer Cells

Apatinib

About this trial

This is an interventional treatment trial for Adenocarcinoma of Lung focused on measuring CIK, Apatinib, Lung Adenocarcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Apatinib alone

Apatinib+CIK

Arm Description

Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.

Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.

Outcomes

Primary Outcome Measures

Overall Survival (OS)

Secondary Outcome Measures

Progression-Free-Survival (PFS)

Full Information

NCT ID

NCT02493582

First Posted

July 7, 2015

Last Updated

February 4, 2016

Sponsor

The First People's Hospital of Changzhou

1. Study Identification

Unique Protocol Identification Number

NCT02493582

Brief Title

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

Official Title

The Randomized, Controlled Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Lung Adenocarcinoma Patients With Wild-Type EGFR

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 2015 (undefined)

Primary Completion Date

July 2030 (Anticipated)

Study Completion Date

July 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First People's Hospital of Changzhou

4. Oversight

Data Monitoring Committee

5. Study Description

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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of Lung

Keywords

CIK, Apatinib, Lung Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib alone

Arm Type

Other

Arm Description

Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.

Arm Title

Apatinib+CIK

Arm Type

Experimental

Arm Description

Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.

Intervention Type

Biological

Intervention Name(s)

Cytokine-Induced Killer Cells

Other Intervention Name(s)

CIK

Intervention Description

CIKs are used with Apatinib to treat lung adenocarcinoma patients with wild-type EGFR

Intervention Type

Drug

Intervention Name(s)

Apatinib

Other Intervention Name(s)

YN968D1

Intervention Description

Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth.

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Progression-Free-Survival (PFS)

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Number of participants with Adverse events

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

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

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