Adoptive TKC Transfer Combined With Chemotherapy for Advanced Non-small Cell Lung Cancer (NSCLC)

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

Inclusion Criteria:

1. Aged≥18 years old and ≤70 years old when signing the informed consent; regardless of gender;
2. Body weight>40kg;
3. Histopathology or cytology confirmed as advanced NSCLC which is not suitable for radical surgical resection;
4. At least one measurable lesion according to the RECIST 1.1 criteria; according to the CT or MRI cross-sectional imaging, the diameter of a single lesion ≤8 cm, or the maximum diameter of a single lesion ≤5 cm and the number of lesions ≤5 (including metastatic lesions).
5. Imaging examination showed no tumor thrombus in the portal vein/inferior vena cava;
6. Acceptable hemopoietic ability: hemoglobin (HGB) >90g/L (no blood transfusion within two weeks), absolute neutrophil count (ANC) >1.5×10^9/L, platelet count >1.0×10^11/L, absolute lymphocyte count (ALC)>500×10^9/L;
7. Prothrombin time (PT)/international normalized ratio (INR) <1.5 ULN and partial thromboplastin time (PTT)/activated partial thromboplastin time (APTT) <1.5 ULN;
8. Acceptable liver and kidney functions: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 ULN in subjects without liver metastases and ≤3.5 upper limit of normal (ULN) in those with liver metastases; bilirubin≤1.5 ULN (excluding hyperbilirubinemia or non-liver-derived hyperbilirubinemia); creatinine ≤1.5 ULN and creatinine clearance rate≥40 mL/min;
9. Women of child-bearing age must be negative for pregnancy test at 7 days before initiation of the treatment.
10. Eastern Cooperative Oncology Group (ECOG) scores≤1.
11. Expected survival no less than 6 months.

Exclusion Criteria:

1. History of any chemotherapy within 2 weeks before a single blood collection;
2. Participating in other clinical trials in the past 30 days;
3. Current on systemic steroid or steroid inhalers;
4. Active brain metastasis or spinal cord compression
5. Uncontrollable pleural and peritoneal effusion requiring clinical treatment or intervention;
6. Active bleeding, and thrombotic diseases requiring treatment;
7. Uncontrolled infectious diseases, such as baseline hepatitis B virus (HBV) DNA≥2000 IU/mL, positive for anti-human immunodeficiency virus （HIV） antibody and hepatitis C virus (HCV)-RNA; Other active infection with clinical significance;
8. Organ failure; Heart: Grade III and IV ; or with hypertension uncontrolled by the standard treatment, history of myocarditis or myocardial infarction within 1 year; Liver: Class C according to the Child-Turcottei-Pugh System (CTP); Kidneys: Kidney failure and uremic syndrome; Lungs: Serious symptoms of respiratory failure; Brain: Disturbance of consciousness;
9. Allergic diathesis and allergic to immunotherapy or relevant drugs;
10. Pregnancy or lactation;
11. History of other active malignancies in the past 5 years, excluding basal or squamous skin carcinoma, superficial bladder cancer, and breast cancer in situ which have completely healed and require no follow-up treatment;
12. Serious autoimmune diseases or immunodeficiency disease, including those with confirmed severe autoimmune diseases and requiring long-term use (over 2 months) of systemic immunosuppressants (steroids) or having immune-mediated symptomatic diseases, such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE) and autoimmune vasculitis (eg., Wegener's granulomatosis);
13. Any mental diseases, including dementia and changes in mental status that may influence the understanding about the informed consent and questionnaire;
14. Judged as serious uncontrollable diseases by the researchers, or other conditions that may interfere with the treatment and therefore being ineligible.