Lung Cancer
Conditions
Interventions
Experimental group:Design the optimal individualized treatment strategy guided by MiniPDX models and K-Cell RNA-seq
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC); 3. Cytologically confirmed malignant pleural effusion; 4. driver gene-negative (EGFR and ALK negative); 5. Treatment-naive patients who have not received any systemic anti-tumor therapy; Patients with postoperative disease recurrence or metastasis and DFS =6monthsregardless of whether they had received adjuvant or neoadjuvant chemotherapy; 6. with measurable lesion; 7. ECOG score 0-2; 8. The expected survival time is not less than 3 months; 9. Adequate hematology function with absolute neutrophil count>=1.5x10^9/L, platelet count>=80x10^9/L, hemoglobin>=90g/L; 10. Adequate hepatic function with total bilirubin=50ml/min; 12. Adequate coagulation function with international normalized ratio (INR) or prothrombin time (PT) <=1.5 ULN; 13. Females of childbearing potential must have a urine study or blood test within 3 days prior to administering the first dose of drugs; 14. Females of childbearing potential and males must use an accepted and effective method of contraception from time of registration and continue for 180 days after the last dose of study treatment; 15. Patients must join the study voluntarily and sign written informed consents before any trial-related procedures.They should be cooperate with treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Currently participating in interventional clinical trails or received treatment with other research drugs or devices within 4 weeks before the first administration; 2. Previously received the following therapies: anti-PD-1, anti-PD-L1, anti-PD-L2 drugs or drugs that stimulates or synergistically inhibits T cell receptors (CTLA4, OX-40, CD137); 3. Received Chinese medicine with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration or received major surgery within 3 weeks before the first administration; 4. Active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis that require clinical intervention; 5. Have received an organ or blood system transplantation; 6. Grade III-IV congestive heart failure (NYHA classification), poorly controlled and clinically significant arrhythmia; 7. Allergic to the active ingredients or any excipients of the drugs used in this study; 8. Patients have history of auto-immune condition requiring ongoing or intermittent systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; 9. Patients receive systemic steroid therapy or any other form of immunosuppressive therapy. Intermittent use of bronchodilators, inhaled corticosteroids or local injections of corticosteroids due to COPD and asthma are allowed; 10. Patients have not fully recovered from toxicity and/or complications caused by any intervention before treatment; 11. Patients were diagnosed with other malignant tumors within 5 years before the first administration. Radically cured skin basal cell carcinoma, skin squamous cell carcinoma and/or radically resected carcinoma in situ are permitted; 12. Non-infectious pneumonia requiring corticosteroid treatment within 1 year before the first administration or current non-infectious pneumonia; 13. Active infection that needs to be treated, or having used systemic anti-infective drugs within one week before the first administration; 14. Mental illness or substance abuse that may affect patients' compliance; 15. Known history of Human immunodeficiency virus (HIV) infection, syphilis infection or active tuberculosis; 16. Untreated active hepatitis B or C; 17. Patients received a live vaccine within 30 days before the first administration. Seasonal flu vaccines that do not contain live virus are permitted; 18. Medical history, disease, treatment or abnormal laboratory results that may interfere with the results and prevent patients from participating in this study. Or the researchers think that it is not in the best interests of patients to participate in this study; 19. Local or systemic diseases caused by non-malignant tumors or secondary reactions of cancer which may lead to higher medical risks and/or uncertainty in survival evaluation; 20. The investigators believe that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective response rate;pleural progression-free survival;safety; | — |
Countries
China
Contacts
Public ContactChunxia Su
Shanghai Pulmonary Hospital
Outcome results
None listed