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

Primary Purpose

Non-small Cell Lung Cancer, Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CIK cell
Gemcitabine Injection
Cisplatin injection
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tianjin Medical University Cancer Institute and Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: CIK+CT

Arm 2: CT

Arm Description

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

Arm 2: We design chemotherapy alone as a control arm

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 27, 2012
Last Updated
October 31, 2019
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01631357
Brief Title
Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer
Acronym
CIK
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: CIK+CT
Arm Type
Experimental
Arm Description
Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.
Arm Title
Arm 2: CT
Arm Type
Active Comparator
Arm Description
Arm 2: We design chemotherapy alone as a control arm
Intervention Type
Biological
Intervention Name(s)
CIK cell
Other Intervention Name(s)
Cytokine-induced killer cell
Intervention Description
CIK cell injection
Intervention Type
Drug
Intervention Name(s)
Gemcitabine Injection
Other Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine injection
Intervention Type
Drug
Intervention Name(s)
Cisplatin injection
Other Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin injection
Primary Outcome Measure Information:
Title
Progression-free survival
Description
PFS was measured from the date of randomization to the first disease progression or to death from any cause, whichever occurred first.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
OS was measured from the date of randomization until death from any cause.
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiubao Ren, MD, PhD
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China

12. IPD Sharing Statement

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

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