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

Tianjin Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Squamous Cell Carcinoma; Non-small Cell Lung Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01631357

CIH-RXB-201205001

Details and patient eligibility

About

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

Full 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

Enrollment: 96 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Arm 1: CIK+CT

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine Injection

Drug: Cisplatin injection

Biological: CIK cell

Arm 2: CT

Active Comparator group

Description:

Arm 2: We design chemotherapy alone as a control arm

Treatment:

Drug: Gemcitabine Injection

Drug: Cisplatin injection