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An Open-label, Randomized, Controlled Study of Gefitinib Plus Autologous Cytokine-Induced Killer Cell Immunotherapy(CIK)Versus Gefitinib Alone As Second Or Third-Line Treatment in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

An Open-label, Randomized, Controlled Study of Gefitinib Plus Autologous Cytokine-Induced Killer Cell Immunotherapy(CIK)Versus Gefitinib Alone As Second Or Third-Line Treatment in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

up to 2 years

Safety Issue:

Yes

Principal Investigator

Xin Song, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Third Affiliated Hospital of Kunming Medicine University

Authority:

China: Ministry of Science and Technology

Study ID:

CIK plus gefitinib

NCT ID:

NCT01871480

Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • CIK
  • Gefitinib
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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