Non-Small Cell Lung Cancer(NSCLC)
Conditions
Interventions
1:Genexol-PM+Cisplatin
2:Paclitaxel Injection + Cisplatin
Sponsors
Guangdong General Hospital; Shanghai Chest Hospital; Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients confirmed by pathological histology and cytology of locally advanced or metastatic NSCLC (version 7 according to TNM classification, clinical stage IIIB/IV), or the patients in the postoperative recurrence, contains: (1) no prior chemotherapy or molecular targeted therapy of the phase of IIIB or IV NSCLC patients; (2) patients with massive metastasis after operation; (3) patients with massive metastasis after postoperative adjuvant therapy more than a years; (4) patients with radiotherapy if radiation areas =10mm ; -Ordinary CT: maximum diameter >=20mm; 3. Eastern Cooperative Oncology Group performance status less than 2; Life expectancy more than 3 months; 4. Age 18-75, both genders; 5. Main organs such as heart, lung, liver and kidney function are basic normal; 6. Blood routine examination should meet the following criteria: (1)ANC>=1.5*10^9/L; (2)PLT >=100*10^9/L; (3)Hb>=90g/L; 7. Blood biochemistry examination should meet the following criteria: (1) TBIL less than 1.5*ULN; (2) ALT, AST,AKP less than 2.5*ULN (Patients with liver metastases: ALT, AST, AKP less than 5*ULN, patients with bone metastases: AKP less than 10*ULN); (3) Cr less than 1.5*ULN; 8. Normal cardiac function in baseline, no serious abnormalities in electrocardiogram (ecg); 9. Complete the evaluation of imaging examination related to tumor curative effect in 2 weeks; Complete clinical symptoms evaluations, blood routine, Routine urine, stool urine, blood biochemistry, electrocardiogram (ecg) and CEA examination in 1 weeks; 10. Understanding the purpose of clinical trials, willing to participation and sign ICF; 11. Good compliance, willing to accept the doctor follow-up and compliance with treatment during the study period; 12. Willingness and capability to be accessible for study follow-up.
Exclusion criteria
Exclusion criteria: 1. The patients with EGFR, ALK mutation; 2. The primary brain tumor or CNS metastases (pia mater metastatic lesions included) except the single brain metastases which had been strictly controlled. CNS tumors after treatment was still associated with cerebral hypertension or nerve mental symptoms; 3. Acute and chronic infections had not been eliminated in patients, or patients with other serious disease at the same time; 4. Researchers believed that patients were not able to finish the whole test process; 5. Patients with >I grade peripheral neuropathy; 6. There was a clear history of allergies to paclitaxel; 7. The third space effusion (such as the massive pleural effusion, pericardial effusion, ascites) could't be controlled by drainage or other methods; No clinical symptoms, patients with small amount of pleural effusion could be enrolled after strictly controlled; 8. Patients with mental illness or mental disorders that can result in poor compliance, incompatibility and unresponse to treatment; 9. Patients who had serious organic disease or major organ failure, such as decompensated heart and lung function failure not to tolerate chemotherapy; 10. Patients with a tendency to hemorrhage disease; 11. Transplants; 12. Patients with addiction to drugs such as narcotics, chronic alcoholics and infectious diseases such as HIV/AIDS; 13. Patients with the long-term use of adrenal cortical hormone or immunosuppressants; 14. Other malignant tumors in five years (in addition to the cured skin basal cell carcinoma); 15. Patients with active hepatitis or liver tumor metastasis for more than three-quarters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactWu Yilong, Han Baohui, Shi Meiqi
Outcome results
None listed