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

• ClinicalTrials.gov Identifier: NCT01631357
• Recruitment Status: Completed
• First Posted: June 29, 2012
• Last Update Posted: November 5, 2019
• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Information provided by (Responsible Party): Tianjin Medical University Cancer Institute and Hospital

Tracking Information

• First Submitted Date: May 27, 2012
• First Posted Date: June 29, 2012
• Last Update Posted Date: November 5, 2019
• Actual Study Start Date: December 2014
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: June 27, 2012): Overall survival [ Time Frame: up to 3 years ]

Current Secondary Outcome Measures (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 (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: Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Non-small Cell Lung Cancer
• Squamous Cell Carcinoma

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 12, 2019): 96
• Original Estimated Enrollment (submitted: June 27, 2012): 200
• Actual Study Completion Date: December 2018
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01631357
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Tianjin Medical University Cancer Institute and Hospital
• Study Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Not Provided

Investigators

• 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