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Keep this study
Lead
Nanjing Luye Sike Pharmaceutical Co., Ltd.
The purpose of this study is to investigate the efficacy and safety of paclitaxel liposome and cisplatin compared with gemcitabine and cisplatin as first-line therapy in advanced squamous non-small-cell lung cancer .
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Aged 18-75 years old, both gender;
2. ECOG: 0-1;
3. Squamous non-small-cell lung cancer (stage IIIB or IV) confirmed by histologically or cytologically ;
4. No prior chemotherapy, biological therapy or immunotherapy; or subjects have recurrence and metastasis more than 6 months after the end of chemotherapy, but not gemcitabine or paclitaxel;
5. At least one radiographically measurable or assessable lesion on chest CG according to RECIST1.1 (response evaluation criteria of solid tumors); regional lymph node metastases may also be measured or assessed by imaging (mediastinal lymph nodes);
6. Life expectancy of at least 12 weeks;
7. Before treatment, blood tests or biochemical measurements must meet the following criteria:
* White blood cell count (WBC)≥ 4.0\*10\^9/L;
* Neutrophil count (ANC)≥ 2.0\*10\^9/L;
* Platelet count (PLT)≥ 100\*10\^9/L;
* Hemoglobin (Hb)≥ 100g/L;
* Hepatic function: serum bilirubin ≤ 1.5 times the upper normal limit,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit;
* Renal function: creatinine ≤ 1.5 times the upper normal limit;
8. Signed informed consent.
You may not be if
1. Hypersensitivity reaction to the interventional drugs;
2. Pregnant or breastfeeding;
3. Women or men of childbearing age who disagree with the use of effective contraceptive measures during the study period;
4. Brain metastase ;
5. Uncontrolled pleural effusion in patients with squamous non-small-cell lung cancer
Clareo Health | Paclitaxel Liposome for Squamous Non-Small-cell Lung Cancer Study(LIPUSU)
