small cell lung cancer
Conditions
Interventions
male patients:Second generation sequencing before first-line chemotherapy
female patients:Second generation sequencing before first-line chemotherapy
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed extensive small cell lung cancer with measurable lesions; 2. Sufficient tissue samples are available to detect gene mutations by second-generation sequencing; 3. Aged 18-70 years old; ECOG PS score: 0-2 points; expected survival time is more than 3 months; 4. The main organ function meets the following criteria within 7 days prior to initial treatment: blood routine test criteria (without blood transfusion within 14 days): hemoglobin(HB) = 90g/L; white blood cells(WBC) =3×10^9/L; absolute neutrophil count(ANC) = 1.5×10^9/L; platelet (PLT) = 80×10^9/L; biochemical test criteria: albumin = 35g/L; total bilirubin (TBIL) = 1.5×ULN(upper limit of normal); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5×ULN,if with liver metastasis, then ALT and AST = 5×ULN; serum creatinine (Cr) = 1.5×ULN or creatinine clearance (CCr) = 60ml / min; doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = low limit of normal (50%).
Exclusion criteria
Exclusion criteria: 1. Patients who have received previous chemotherapy or other anti-tumor treatment; 2. Non-small cell lung cancer or limited small cell lung cancer; 3. Suffered from other malignant tumors within 5 years or currently, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (in situ carcinoma) and T1 (tumor infiltrating basement membrane)]; 4. Patients with any severe and/or uncontrolled disease, including: unsatisfactory blood pressure control (systolic blood pressure >150 mmHg, diastolic blood pressure >90 mmHg); grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval = 440ms) and = grade 2 congestive heart failure (New York Heart Association (NYHA) classification); active or uncontrolled serious infection (= CTC AE grade 2 infection); cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis required antiviral therapy; renal failure required hemodialysis or peritoneal dialysis; With a history of immunodeficiency, including HIV-positive,other acquired/congenital immunodeficiency disease or organ transplantation; poor diabetes control (fasting blood glucose (FBG)>10mmol/L); urine routine test indicates that urine protein = ++ and 24-hour urine protein quantitation > 1.0 g; epileptic seizure required treatment; with pleural effusion or ascites causing respiratory syndrome (= CTC AE grade 2 dyspnea); suffered from major surgical treatment or significant traumatic injury within 28 days; with any sign or history of hemorrhage, regardless of severity; any bleeding event= CTC AE grade 3 within 4 weeks prior to first-line chemotherapy; unhealed wounds, ulcers or fractures; Arteriovenous thrombotic disease occurred within 6 months, such as cerebrovascular accident(including transient ischemic attack), deep vein thrombosis, and pulmonary embolism; with a history of addictable psychotropic drug abuse or mental disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of mutant genes;mutant genes;chemotherapy efficacy;progression-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactRunbo Zhong
Shanghai Chest Hospital
Outcome results
None listed