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Phase II/III Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy in Stage IIIb-IV Squamous Non-Small-Cell Lung Cancer


Phase 2/Phase 3
18 Years
80 Years
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Phase II/III Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy in Stage IIIb-IV Squamous Non-Small-Cell Lung Cancer


1. Phase II/III study,

2. Randomized, open-label study,

3. evaluated the effects of chemotherapy combination with autologous cytokine-induced
killer Cell immunotherapy compared with chemotherapy in patients with stage IIIb-IV
squamous non-small-cell lung cancer


Inclusion Criteria:



- Sex: male or female

- Age: from 18 to 80 years

- Histology: squamous non-small-cell lung cancer

- Clinical stage: from stage IIIb to stage IV

- Therapy: not received chemotherapy, radiotherapy, or immunotherapy before entry into
this study

- Karnofsky performance status: more than 50%

- Expected survival: more than 2 months

- Laboratory tests results 7 days before the start of treatment:

White blood cells: more than 3.0 × 109/L Platelets: more than 100 × 109/L Neutrophils:
more than 1.5 × 109/L Hemoglobin: more than 80g/L Serum glutamate pyruvate transaminase:
less than 2.5 folds of the upper normal limit (ULN) Serum glutamic-oxal (o)
acetic transaminase: less than 2.5 × ULN Serum bilirubin: less than 1.25 × ULN Serum
creatinine: less than 1.25 × ULN

- pregnancy test: the test of women of child-bearing period must be negative 7 days
before the start of treatment

- Contraception: male and female subjects of child-bearing period must adopt a reliable
method of contraception before entry into this study until 30 days after stopping
this study

- Informed consent: subject must have the ability to understand and voluntarily sign a
written informed consent

Exclusion Criteria:

- History of neoplasms: other neoplasms

- Medical history: mental disease, or congestive heart failure, or severe coronary
artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy

- History of allergies: allergic to the study drugs

- Metastasis: clinical symptoms of brain metastasis

- Other clinical trial: the subject received other clinical trial before this study

- Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B
virus, or hepatitis C virus was positive

- Woman: pregnant or lactating women

- Compliance: poor compliance

- History of neoplasms: other neoplasms

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

up to 3 years

Safety Issue:

Yes

Principal Investigator

Xiubao Ren, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Tianjin Medical University Cancer Institute and Hospital

Authority:

China: Food and Drug Administration

Study ID:

CIH-RXB-201205001

NCT ID:

NCT01631357

Start Date:

February 2013

Completion Date:

December 2015

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms

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