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NCT Number: NCT01631357

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

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

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

About this study

  • Phase II/III study,
  • Randomized, multicenter, open-label study,
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CIK cell

Biological

CIK cell injection

Other names: Cytokine-induced killer cell

Gemcitabine injection

Drug

Gemcitabine injection

Other names: Gemcitabine

Cisplatin injection

Drug

Cisplatin injection

Other names: Cisplatin

Primary outcomes

  1. 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.

Secondary outcomes

  1. Overall survival

    Time frame: up to 3 years

    OS was measured from the date of randomization until death from any cause.

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study 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

Acronym: CIK

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2012
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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