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

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

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer; Squamous Cell Carcinoma
• Intervention / Treatment: Biological: CIK cell; Drug: Gemcitabine Injection; Drug: Cisplatin injection

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
• Enrollment (Actual): 96
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: CIK+CT; Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.	Biological: CIK cell; CIK cell injection; Other Names: Cytokine-induced killer cell; Drug: Gemcitabine Injection; Gemcitabine injection; Other Names: Gemcitabine; Drug: Cisplatin injection; Cisplatin injection; Other Names: Cisplatin
Active Comparator: Arm 2: CT; Arm 2: We design chemotherapy alone as a control arm	Drug: Gemcitabine Injection; Gemcitabine injection; Other Names: Gemcitabine; Drug: Cisplatin injection; Cisplatin injection; Other Names: Cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	OS was measured from the date of randomization until death from any cause.	up to 3 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Study Chair: Xiubao Ren, MD, PhD, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 27, 2012
• First Submitted That Met QC Criteria: June 27, 2012
• First Posted (Estimate): June 29, 2012

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Cisplatin
• Other Study ID Numbers: CIH-RXB-201205001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No