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Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer (CIK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01631357
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Tracking Information
First Submitted Date  ICMJE May 27, 2012
First Posted Date  ICMJE June 29, 2012
Last Update Posted Date November 5, 2019
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2019)
Progression-free survival [ Time Frame: up to 3 years ]
PFS was measured from the date of randomization to the first disease progression or to death from any cause, whichever occurred first.
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
Overall survival [ Time Frame: up to 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2019)
Overall survival [ Time Frame: up to 3 years ]
OS was measured from the date of randomization until death from any cause.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
Progression-free survival [ Time Frame: up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer
Official Title  ICMJE Phase II/III Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy in Stage IIIb-IV Squamous Non-Small-Cell Lung Cancer
Brief Summary This randomized, multicenter,open-label phase II/III study is to evaluate the effects of chemotherapy combination with autologous cytokine-induced killer Cell immunotherapy in patients with stage IIIb-IV squamous non-small-cell lung cancer
Detailed Description
  1. Phase II/III study,
  2. Randomized, multicenter, 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-small Cell Lung Cancer
  • Squamous Cell Carcinoma
Intervention  ICMJE
  • Biological: CIK cell
    CIK cell injection
    Other Name: Cytokine-induced killer cell
  • Drug: Gemcitabine Injection
    Gemcitabine injection
    Other Name: Gemcitabine
  • Drug: Cisplatin injection
    Cisplatin injection
    Other Name: Cisplatin
Study Arms  ICMJE
  • Experimental: Arm 1: CIK+CT
    Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.
    Interventions:
    • Biological: CIK cell
    • Drug: Gemcitabine Injection
    • Drug: Cisplatin injection
  • Active Comparator: Arm 2: CT
    Arm 2: We design chemotherapy alone as a control arm
    Interventions:
    • Drug: Gemcitabine Injection
    • Drug: Cisplatin injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2019)
96
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2012)
200
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01631357
Other Study ID Numbers  ICMJE CIH-RXB-201205001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tianjin Medical University Cancer Institute and Hospital
Study Sponsor  ICMJE Tianjin Medical University Cancer Institute and Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Xiubao Ren, MD, PhD Tianjin Medical University Cancer Institute and Hospital
PRS Account Tianjin Medical University Cancer Institute and Hospital
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP