squamous cell lung cancer
Conditions
Interventions
Experimental group:nab-paclitaxel: 100mg/m2 iv d1, 8, 15 Carboplatin AUC=5-6 iv d1, (man AUC=5
female AUC=6) q3w 4cycles
Control:sb-Paclitaxel: 175mg/m2 iv d1, q3w 4cycles
Carboplatin AUC=5-6 iv d1, (man AUC=5
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged =18 years old man and female; 2. Pathologically diagnosed with squamous cell lung cancer; 3. Imageology diagnosed with metastatic/recurrent squamous cell lung cancer; 4. None previous therapy and recurrence 2 years after surgery (except neoadjuvant or adjuvant therapy; Prior radiation therapy is allowedirradiated lesion is not including measurable lesions unless documented progress after radiation.); 5. Patients with measurable lesions (measuring=10mm on spiral CT scan, According to the criteria in RECIST1.1); 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 7. Life expectancy greater than or equal to 3 months; 8. Major organ function has to meet the following certeria: 1) For results of blood routine test without blood transfusions and blood products within 14 days, without G-CSF and other hematopoietic stimulating factors: HB=90g/L; ANC=1.5×10^9/L; PLT=80×109/L; 2) For results of blood biochemical test: TBIL<1.5?ULN; ALT and AST=2.5?ULN, but =5?ULN if the transferanse elevation is due to liver metastase; BUN and Cr=1×ULN or Endogenous creatinine clearance rate =50ml/min; Cardiac ultrasound revealed left ventricular ejection fraction (LVEF) = 50%; 9. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks; 10. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Symptomatic brain metastases 2. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ) 3. Patients with unstable angina, congestive heart failure, severe arrhythmias or the other uncontrolled diseases 4. History of psychiatric drugs abuse or patients with mental disorders 5. Pregnant or lactating women 6. Less than 4 weeks from the last clinical trial 7. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR;OS;Safety;Qol; | — |
Countries
China
Contacts
Public ContactYibing Liu
The Fourth Hospital of Hebei Medical University
Outcome results
None listed