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The purpose of this study is to evaluate the effectiveness and safety of albumin bound paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive patients with advanced gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin Bound Paclitaxel With 5-FU/CF | Experimental | Albumin Bound Paclitaxel 150 mg/m2 (on day 1),5FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin Bound Paclitaxel | Drug | Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS(Progression-free survival ) | The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death | 80% PFS events,, an expected average of 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS (Overall survival ) | Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death. | OS follow-up period: 18 months or 80% OS events, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| ORR (Overall tumor response) | Overall tumor response: This is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions. | 80% PFS events, an expected average of 10 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruihua Xu, PhD,MD | Contact | 862087343228 | xurh@sysucc.org.cn | |
| Dongsheng Zhang, PhD,MD | Contact | 862087343795 | zhangdsh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ruihua Xu, PhD,MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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|
| 5-FU | Drug | 5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity. |
|
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |