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

Non-small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631357
• Other study ID #: CIH-RXB-201205001
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: November 2014
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Squamous Cell Carcinoma

Intervention

Biological:
• CIK cell
CIK cell injection

Drug:
• Gemcitabine Injection
Gemcitabine injection
• Cisplatin injection
Cisplatin injection

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	OS was measured from the date of randomization until death from any cause.	up to 3 years