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

Adenocarcinoma of Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02493582
• Other study ID #: CAA
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 7, 2015
• Last updated: February 4, 2016
• Start date: July 2015
• Est. completion date: July 2033

Study information

• Verified date: February 2016
• Source: The First People's Hospital of Changzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• Study type: Interventional

Clinical Trial 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

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) .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: July 2033
• Est. primary completion date: July 2030
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Neoplasms

Intervention

Biological:
• Cytokine-Induced Killer Cells
CIKs are used with Apatinib to treat lung adenocarcinoma patients with wild-type EGFR

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Changzhou

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with Adverse events		1 month	Yes
Primary	Overall Survival (OS)		3 months	No
Secondary	Progression-Free-Survival (PFS)		3 months	No