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Evaluate the efficacy and safety of Apatinib (500mg/d) with gemcitabine(1000mg/m2) in advanced metastatic pancreatic cancer.
This test is a single center, one-armed exploratory clinical research, aimed at the evaluation the efficacy and safety of Apatinib with Gemcitabine in the patients with advanced metastatic pancreatic cancer.
This study plan in Tianjin Medical University Cancer Institute and Hospital.From launched in July 2016, this research intends to recruit the end time about as of December 2017, is expected to the end of the test time is in December 2017.
If do not have the appearance of the following circumstances, such as the subjects out of informed consent, drug toxicity tolerance or the researchers think that do not fit for further test, each subject research and treatment time is expected until imaging of tumor progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Apatinib:500 mg,po,qd, d1-14, every 3 week Gemcitabine:1000mg/m²,vein input 30-40,d1,d8,every 3 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib:500 mg,po,qd, d1-14, every 3 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | 1 years | |
| Overall Survival (OS) | 1 years | |
| Life Quality Score (QoL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Ji Hui, PhD | Contact | 022-23340123 | 3070 | renhe@tjmuch.com |
| Ren He, PhD | Contact | 022-23340123 | 3070 | renhe@tjmuch.com |
| Name | Affiliation | Role |
|---|---|---|
| Hao Ji Hui, PhD | National Clinical Research Center for Cancer of China | Principal Investigator |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine | Drug | Gemcitabine:1000mg/m²,vein input 30-40,d1,d8,every 3 week |
|
| 1 years |
| Disease Control Rate (DCR) | 1 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |