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

NCT01631357 | Completed Phase 2 DMC

• 1 other identifier: CIH-RXB-201205001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Non-small Cell Lung Cancer; Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  PFS was measured from the date of randomization to the first disease progression or to death from any cause, whichever occurred first.

  up to 3 years

Secondary Outcomes (1)

• Overall survival

  up to 3 years

Study Arms (2)

Arm 1: CIK+CT

EXPERIMENTAL

Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.

Biological: CIK cell; Drug: Gemcitabine Injection; Drug: Cisplatin injection

Arm 2: CT

ACTIVE COMPARATOR

Arm 2: We design chemotherapy alone as a control arm

Drug: Gemcitabine Injection; Drug: Cisplatin injection

Interventions

CIK cell BIOLOGICAL

CIK cell injection

Also known as: Cytokine-induced killer cell

Arm 1: CIK+CT

Gemcitabine Injection DRUG

Gemcitabine injection

Also known as: Gemcitabine

Arm 1: CIK+CT; Arm 2: CT

Cisplatin injection DRUG

Cisplatin injection

Also known as: Cisplatin

Arm 1: CIK+CT; Arm 2: CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Xiubao Ren, MD, PhD

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2012
• First Posted: June 29, 2012
• Study Start: December 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 5, 2019

Record last verified: 2014-11

Locations

CN (1)