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

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Gemcitabine; Paclitaxel

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