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This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and some biomarkers is also to be evaluated.
Albumin-bound paclitaxel(nab-P) utilizes the albumin binding proteins,such as (gp60)/caveolin-1 (CAV1) and SPARC(secreted protein acidic and rich in cysteine), achieving high intratumoral paclitaxel accumulation. It is reported that CAV1 is overexpressed in squamous cell cancer(SQC), so it is possible that nab-PC is more highly active than GC in SQC of lung.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin paclitaxel plus carboplatin | Experimental | Treatment of Albumin paclitaxel plus carboplatin |
|
| Gemcitabine plus carboplatin | Active Comparator | Treatment of Gemcitabine plus carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin paclitaxel plus carboplatin | Drug | Patients receive carboplatin AUC=5 q3w and nab-p 135 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate(ORR) | ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks. | 18weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response duration, progression free survival, overall survival, safety profile | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wu Yilong, professor | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30739019 | Derived | Wang Z, Huang C, Yang JJ, Song Y, Cheng Y, Chen GY, Yan HH, Ben XS, Wang BC, Xu CR, Jiang BY, Zhou Q, Chen HJ, Wu YL. A randomised phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in advanced squamous cell lung carcinoma (C-TONG1002). Eur J Cancer. 2019 Mar;109:183-191. doi: 10.1016/j.ejca.2019.01.007. Epub 2019 Feb 7. | |
| 25239521 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
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|
| Gemcitabine plus carboplatin | Drug | Patients receive carboplatin AUC=5 q3w and gemcitabine 1250 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest. |
|
|
| Derived |
| Yang JJ, Huang C, Chen GY, Song Y, Cheng Y, Yan HH, Zhou Q, Wu YL. A randomized phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in locally advanced or metastatic squamous cell carcinoma of lung. BMC Cancer. 2014 Sep 20;14:684. doi: 10.1186/1471-2407-14-684. |
| 22461458 | Derived | Gold KA, Wistuba II, Kim ES. New strategies in squamous cell carcinoma of the lung: identification of tumor drivers to personalize therapy. Clin Cancer Res. 2012 Jun 1;18(11):3002-7. doi: 10.1158/1078-0432.CCR-11-2055. Epub 2012 Mar 29. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003562 |
| Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |