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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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To verify the role of nab-paclitaxel in second or later-line treatment in advanced biliary tract cancers, the investigators designed a prospective, exploratory, single arm,single center phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as second or later-line treatment in advanced biliary tract cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nab-paclitaxel and Cisplatin | Experimental | cisplatin and nab-paclitaxel: Nab-paclitaxel, 130mg/m2, d1,d8, Cisplatin, 20mg/m2, d1-3 ,3week, 4-6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin and nab-paclitaxel | Drug | Nab-paclitaxel, 130mg/m2, d1,d8, Cisplatin, 20mg/m2, d1-3 ,3week, 4-6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate [ORR] | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival [PFS] | 2 years | |
| Overall survival [OS] | 2 years | |
| Disease Control Rate [DCR] |
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Inclusion Criteria:
Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function:Total bilirubin ≤ 1.5x ULN;AST and ALT) ≤ 2.5x ULN Renal function:Cr ≤ 1.5x ULN,Ccr ≥ 45 ml/min Coagulation function:INR≤1.5×ULN, PT≤1.5ULN, APTT within the normal range
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianwei Zhou, MD&PhD | Contact | 13298360725 | drzhoujw@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology , Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University | Recruiting | Zhengzhou | Henan | 450003 | China |
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| 2 years |
| adverse events | 2 years |
|
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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