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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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It is a trial to compare the efficacy and safety of Nab-paclitaxel plus Cisplatin vs Gemcitabine plus Cispatin as first line chemotherapy in advanced biliary tract cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nab-paclitaxel + Cisplatin | Experimental | Patients in this arm receive chemotherapy with Nab-paclitaxel plus Cisplatin |
|
| Gemcitabine + Cisplatin | Active Comparator | Patients in this arm receive chemotherapy with Gemcitabine plus Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-paclitaxel + Cisplatin | Drug | Nab-paclitaxel 125mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS is defined as time from the start of treatment to progression of disease or death. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The rate of participants that achieve either a complete response (CR) or a partial response (PR). | up to 3 years |
| OS | Overall survival is defined as time from the start of treatment until death due to any reason. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Zhuang, professor | Contact | +8613006325115 | mrzhuangliang@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40819029 | Derived | Yang X, Dai YH, Peng H, Zhang MS, Fu Q, Liu SF, Sun L, Zou YM, Xu HS, Qiu P, Qiu H, Huang Q, Cheng HH, Zhuang L. Nab-paclitaxel plus cisplatin versus gemcitabine plus cisplatin as first-line treatment in advanced biliary tract cancer: results of a multicentre, randomised, phase II trial. BMC Cancer. 2025 Aug 16;25(1):1321. doi: 10.1186/s12885-025-14581-3. |
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| Gemcitabine + Cisplatin | Drug | Gemcitabine1000mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days. |
|
| up to 3 years |
| TTP | Time to progress is defined as time from randomized grouping to objective progression of tumors. | up to 3 years |
| AEs | Adverse reactions refer to the occurrence and development of diseases in the process of using drugs according to normal usage and dosage to prevent, diagnose or treat diseases.Adverse reactions unrelated to the purpose of treatment. | up to 3 years |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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