MedDataX Logo

CIK Cell Transfusion Plus Gefitinib As Second Or Third-Line Treatment for Advanced Adenocarcinoma Non-Small Cell Lung Cancer

NCT ID: NCT01871480

Last Updated: 2013-12-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and adenocarcinoma is the most prevalent subtype. Gefitinib showed lower efficiency of treatment as second or third-line in patients with advanced adenocarcinoma NSCLC. It is necessary to further improve the efficiency of treatment in patients with advanced NSCLC. Immunotherapy with cytokine-induced killer cells (CIK) may improve tumor control and survival, as well as a better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma NSCLC.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and adenocarcinoma is the most prevalent subtype. The epidermal growth factor receptor (EGFR) adenosine triphosphate-competitive tyrosine kinase inhibitors gefitinib showed success in the treatment of advanced adenocarcinoma NSCLC following the failure of front-line chemotherapy. However, the efficiency of treatment as second or third-line in patients with advanced adenocarcinoma NSCLC is also low. It is necessary to further improve the efficiency of treatment in patients with advanced NSCLC. Biological treatment is an effective adjuvant treatment in comprehensive cancer treatment. Immunotherapy with cytokine-induced killer cells (CIK) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum, this effect may improve tumor control and survival, as well as a better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma NSCLC.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small Cell Lung Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

NSCLC CIK Gefitinib Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Gefitinib combination with CIK cell immunotherapy

Group Type EXPERIMENTAL

Group A:cytokine-induced killer cell +gefitinib

Intervention Type DRUG

CIK cells: intravenous infusions; D14-16; one cycle every month,at least 6 cycles;Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity.

Group B

Gefitinib alone

Group Type ACTIVE_COMPARATOR

Group B:Gefitinib

Intervention Type DRUG

Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group A:cytokine-induced killer cell +gefitinib

CIK cells: intravenous infusions; D14-16; one cycle every month,at least 6 cycles;Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity.

Intervention Type DRUG

Group B:Gefitinib

Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age between 18 to 80 years
* Histologically or cytologically proven advanced adenocarcinoma non-small-cell lung cancer
* Life expectancy more than 12 weeks
* Not received EGFR agent or cell immunotherapy before entry into this study
* World Health Organization- Eastern Cooperative Oncology Group Performance Status 0-3
* Gefitinib as the second or third line therapy
* More than 4 weeks must have completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects
* Disease measurable
* Patients must have adequate organ and marrow functions as defined below: white blood cells: more than 3.0×109/L, Neutrophils: more than 1.5×109/L, Platelets: more than 75×109/L, Hemoglobin more than 80g/L, Serum total bilirubin less than 1.25 folds of the upper normal limit (ULN), Serum glutamic-oxal (o) acetic transaminase: less than 2.5×ULN, Serum glutamate pyruvate transaminase: less than 2.5×ULN, Serum creatinine: less than 1.25×ULN, Blood urea nitrogen: less than 2×ULN.
* Pregnancy test: the test of women of child-bearing period must be negative before entry into this study
* Subject must have good compliance and voluntarily to sign a written informed consent

Exclusion Criteria

* Acute infection
* Uncontrolled concurrent illness: hypersensitiveness, asthma, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, serious heart valve disease
* Psychiatric illness, pharmacological dependence, or other situation that would limit compliance with study requirements
* History of other neoplasms
* Coagulation disorder and bleeding tendency
* Pertinacious hypertension（systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg) after aggressive therapy
* Brain metastasis with symptomatic
* Severe liver dysfunction
* Autoimmune disease (e.g. systemic lupus erythematosus, rheumatoid arthritis, thyroadenitis, et al )
* Patients who diagnosed as virus hepatitis, syphilis or HIV, or other infectious diseases
* Employment of corticosteroids or other immunodepressive hormone therapies
* With main organs transplantation
* Pregnant or lactating women
* Known or suspected in patients with severe hypersensitivity to CIK or gefitinib or to any other component of gefitinib
* Patients receiving any other investigational agents in 30 days or prepare to participate in other investigation in the clinical period
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kunming Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Song Xin

Chief of the Department of Cancer Biotherapy Center, The Third Affiliated Hospital of Kunming Medicine University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xin Song, MD

Role: STUDY_CHAIR

The Third Affiliated Hospital of Kunming Medicine University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Cancer Biotherapy Center, The Third Affiliated Hospital of Kunming Medicine University

Kunming, Yunnan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIK plus gefitinib

Identifier Type: -

Identifier Source: org_study_id