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The purpose of this study is to investigate the efficacy and the safety of paclitaxel liposome and cisplatin compared with gemcitabine and cisplatin as first-line therapy in advanced squamous non-small-cell lung cancer .
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LP group | Experimental | Liposome paclitaxel(Lipusu®) plus cisplatin. Paclitaxel liposome Sterile injection powder 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles. Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles. |
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| GP group | Active Comparator | Gemcitabine (Gemzar®) plus cisplatin. Gemcitabine hydrochloride for injection 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles. Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel Liposome | Drug | Paclitaxel liposome injection 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression free survival will be calculated from study entry to documented disease progression using RECISTv1.1 or death from any cause, whichever occurs first. | From study entry to measured progressive disease, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate is the percentage of participants who achieve best overall tumor response of complete response or partial response . | From study entry to measured progressive disease, up to 2 years |
| Overall Survival |
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Inclusion Criteria:
Aged 18-75 years old, both gender;
ECOG: 0-1;
Squamous non-small-cell lung cancer (stage IIIB or IV) confirmed by histologically or cytologically ;
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;
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);
Life expectancy of at least 12 weeks;
Before treatment, blood tests or biochemical measurements must meet the following criteria:
Signed informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| caicun zhou, doctor | Shanghai Pulmonary Hospital, Shanghai, China | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34699693 | Derived | Zhang J, Pan Y, Shi Q, Zhang G, Jiang L, Dong X, Gu K, Wang H, Zhang X, Yang N, Li Y, Xiong J, Yi T, Peng M, Song Y, Fan Y, Cui J, Chen G, Tan W, Zang A, Guo Q, Zhao G, Wang Z, He J, Yao W, Wu X, Chen K, Hu X, Hu C, Yue L, Jiang D, Wang G, Liu J, Yu G, Li J, Bai J, Xie W, Zhao W, Wu L, Zhou C. Paclitaxel liposome for injection (Lipusu) plus cisplatin versus gemcitabine plus cisplatin in the first-line treatment of locally advanced or metastatic lung squamous cell carcinoma: A multicenter, randomized, open-label, parallel controlled clinical study. Cancer Commun (Lond). 2022 Jan;42(1):3-16. doi: 10.1002/cac2.12225. Epub 2021 Oct 26. |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine | Drug | Gemcitabine 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles. |
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| Cisplatin | Drug | Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles. |
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Overall survival is defined from study entry to the date of death from any cause.
| From study entry to death from any cause, up to 2 years |
| Adverse events | Adverse events is evaluated according to Common Terminology Criteria for Adverse Events Version 4.0 | From baseline until 21 days after the last dose |
| Quality of Life questionnaire | The quality of life is assessed using the European Organization for the Research and Treatment of Cancer Questionnaire Core-30 (EORTC QLQ-C30) and Quality of Life Questionnaire Lung Cancer 13(QLQ-LC13). | From study entry to measured progressive disease, up to 2 years |
| Correlation between gene sequence or expression level and therapeutic effect | Correlation between gene sequence or expression level and therapeutic effect is assessed using the blood or tumor tissue of subjects by genetic testing | From study entry untill radiological disease progression, up to 2 years |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |