Advanced squamous cell lung carcinoma
Conditions
Interventions
1:TXT 75 mg/m2, d1, iv drop LBP 30mg/m2, d2, iv drop
2:TXT 75 mg/m2, d1, iv drop DDP 75 mg/m2, d2, iv drop
Sponsors
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years old, men and women; 2. Be diagnosed as lung cancer squamous cell carcinoma by histopathology or cytology and other tests. (Not including adenosquamous carcinoma); 3. Locally advanced or metastatic lung squamous cell carcinoma patients whose Clinical stage was stage ?B or IV .(According to IASLC2009 lung cancer TNM stage); 4. First-line chemotherapy. If the patient has received neoadjuvant chemotherapy or adjuvant chemotherapy, the end time of chemotherapy from entering the group should greater or equal to 6 months; 5. Did not receive any palliative chemotherapy or molecular targeted drug therapy for NSCLC.( Including monoclonal antibodies or small molecular tyrosine kinase inhibitors etc.); 6. Patients who had previously received radiotherapy may be enrolled if they subject to all the following conditions : The primary target lesion did not undergo radiotherapy or radiotherapy progress Acute toxicity of previous radiotherapy had been restored=level 1 The end time of radiotherapy from entering the group should =4 weeks. 7 There must be at least one measurable lesion.(According to RECIST1.1) 8 ECOG PS 0 or 1 9 The expected survival time=3 mouths 10 The check of baseline laboratory would subject to all the following conditions: Bone Marrow Function: Blood neutrophils( ANC) Absolute count=1.5×109/L; PLT=100×109/LHB=90g/L Liver Function: serum total bilirubin( STB) conjugated bilirubin( CB)= upper limit of normal( ULN)×2.5( in the absence of liver metastases);or ULN×5( in the case of liver metastases) Kidney Function: serum creatinine( Cr)=ULNCr=55 ml/min( Apply the Cockcroft-Gault formula) Coagulation: international normalized ratio(INR) of prothrombin time(PT) =ULN×1.5 11 Female: To be sterilized after surgery or after menopause, take contraceptive measures during the treatment and within 6 months after the end of the treatment;Non-lactation; Male: To be sterilized after surgery or take contraceptive measures during the treatment and within 6 months after the end of the treatment; 12 The patients volunteered and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. There was a history of allergies to platinum compounds; 2. Previously used paclitaxel drugs, or polyoxyethylene castor oil have a history of allergies; 3. Had a major surgery within 4 weeks prior to enrollment the study, or surgical wounds had not yet healed completely; 4. The toxicity caused by previous anti-tumor treatment, is still = CTCAE 3 level; 5. The clinical symptoms and signs pointed to brain metastases, the patients should take the cerebral magnetic resonance imaging (MRI) examination, if found that brain metastases, they cannot be enrolled . The patients with brain metastases previously who have completed brain metastases, and the end of treatment from the study group = 4 weeks, have no obvious symptoms at present, and no need to use steroid therapy, can be enrolled ; 6. There are the main bronchus or bronchial stenosis or blockage, superior vena cava syndrome caused by the serious tumor invasion and oppression, or more than the amount of malignant chest, peritoneal effusion, not yet controlled; 7. Have other histological sources of malignant tumors in the past 5 years except the full treatment of cervical carcinoma in situ and skin basal cell carcinoma or squamous cell carcinoma; 8. Severe cardiovascular disease, including unmanageable hypertension, unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure> New York Heart Association Heart Disease Classification (NYHA) Grade II (seeing Appendix 8) , Severe arrhythmia and pericardial effusion,etc.; 9. Have a bleeding(=CTCAE level 3) occurred within 4 weeks prior to enrollment the study; 10. Requires long-term use of anticoagulants or vitamin K antagonists such as warfarin, heparin or analogues thereof excepts small doses of warfarin for prevention purposes(1mg ,p.o. ,q.d. ) or aspirin(the dose of one day=100mg); 11. Serious infection requires intravenous antibiotics, antifungal or antiviral therapy; 12. Suffering from mental illness, poor compliance; 13. The cases that the researchers do not consider appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;1-y OS;2ys OS;ORR;DCR;Quality of Life;Safetly; | — |
Countries
China
Contacts
Public ContactCao Yilin
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Outcome results
None listed