Advanced lung squamous cell carcinoma
Conditions
Interventions
experimental group:Nedaplatin+gemcitabine
control group:cisplatin+gemcitabine
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Primary lung squamous cell carcinoma(excluding adenosquamous carcinoma) confirmed by cytology or histology(excluding diagnosed by separate sputum cytologyseparate sputum cytology); 2. According to TNM new staging of IASLC2009 lung cancer, the lung squamous cell carcinoma of the IIIB stage or IV stage, which is not willing to be or without without preconditions to get radiotherapy; 3. According the RRECIST criteria, the tumor at least have one can be evaluated lesion (at least 10mm of the maximum diameter of the spiral CT, 20mm of the average CT); 4. Male of female, 18 years of age or older andless than 75 years; 5. ECOG PS 0 OR 1; 6. The expected survival time over 12 weeks; 7. Blood function: absolute neutrophil count (ANC) >=2*10^9/L andplatelet count over 100*10^9/L and hemoglobin was greater than 9 g/dL; 8. Liver function: total bilirubin is less than or equal to the upper limit of normal (ULN); levels of ALT andAST is less than or equal to 2.5 times the normal value of the upper limit of normal (ULN); alkaline phosphatase is less than or equal to 5 times the normal value upper limit of normal (ULN); 9. Renal function:The serum creatinine is less or equal to the upper limit of normal (ULN) or the calculated creatinine clearance rate was higher than 60 mL/min; 10. The patients have not received the anti- tumor drug treatment in the past; 11. The patients who had performed surgery for more than 4 weeks, and the patients have recovered; 12. The female cases with an intact uterus (except amenorrhea has 24 months) must have a negative pregnancy test results in recent 28 days before the study. If pregnancy tests were administered for exceeding 7 days from the first time, it is need an urine pregnancy test that could be comfirmed.(before 7 days of the first medication); 13. Signed informed consent, that is required to be approved by the independent ethics committee andto obtain informed consent of patients before any substantial testing procedure.
Exclusion criteria
Exclusion criteria: 1. In the last 5 years, the patients with other malignant tumors, but not including the treatment of skin basal cell carcinoma andcervical carcinoma in situ. 2. There is evidence of central nervous system (CNS) transfer, even if previously, andthe patients should be scanned for MRI or enhanced CT scan in 28 days before r the entry into the group for removal of CNS. 3.Previously treated with radiotherapy (pain to palliative radiotherapy andevaluate the lesion was not in the radiation field except) 4. The patients have used chemotherapy before(except bisphosphonate). 5. There is no control of systemic disease, including active infection, uncontrolled hypertension, diabetes, unstable angina, congestive heart failure, myocardial infarction (1 years before treatment), andthe severe arrhythmia with drug treatment ,liver kidney andmetabolic disease 6. Women in pregnancy or lactation 7. Patients (male or female) have the possibility of ?procreating but are not willing or not take effective contraceptive measures. 8. The patients have accepted the trial of other clinical studies (in the treatment of clinical research) at the same time. 9. The patients were allergic to the hemotherapy drugs. 10. There is evidence to prove that there are other diseases, neurological or metabolic abnormalities, abnormal physical examination or laboratory abnormalities, andsuspected, that may be a high risk of complications associated with the study drugs or other related complications. 11.The patients have accepted bone marrow transplantation in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR=CR+PR+SD;TTP;clinical symptoms;OS; | — |
Countries
China
Contacts
Public ContactZhong Jincai
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed