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The main research purpose Evaluation of objective response Apatinib second-line treatment of advanced pancreatic cancer (ORR) and the rate of progression free survival (PFS).
Objective to study the objective and exploratory secondary research To observe the Apatinib in second line treatment of advanced pancreatic cancer disease control rate (DCR), patients with overall survival (OS) benefit, treatment effects on quality of life (QOL) score and drug safety evaluation, To investigate the relationship of apatinib as second-line treatment of advanced pancreatic cancer and the expression of vascular endothelial growth factor receptor(VEGFR) in the serum
The purpose of this study is to determine what effects apatinib has on advanced pancreatic cancer patients after failure of first-line chemotherapy cannot tolerate second-line chemotherapy or unwilling to receive second-line chemotherapy of pancreatic cancer patients.To investigate the relationship between apatinib as second-line treatment of advanced pancreatic cancer and the expression of vascular endothelial growth factor receptor(VEGFR) in the serum.
This study choose the First Affiliated Hospital of Xi'an JiaoTong University were unable to tolerate the failure of first-line chemotherapy for second-line chemotherapy or unwilling to receive second-line chemotherapy of pancreatic cancer patients as the research object, the clinical data of clinical subjects age and sex, Eastern Cooperative Oncology Group (ECOG) score, tumor stage, pathological type, pathological grading, giving apatinib treatment, during the treatment of blood monitoring in patients with CA199 levels, imaging findings, assessment of tumor related symptoms and adverse events, and the expression of VEGFR in blood was measured by ELISA method, the curative effect evaluation of the end of the 2 cycle of treatment, patients with effective evaluation to oral apatinib, through the statistical analysis of the data of complete remission (CR) or partial remission (PR), the rate of progression free survival (PFS) expression of CA199 content in serum and serum VEGFR levels of the relevant indicators,. Explore Apatinib for the curative effect and safety of the second-line treatment of advanced pancreatic cancer, and to explore the relationship between the serum VEGF expression level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib | Experimental | Patients will be offered with Apatinib (850mg daily,orally)until their disease have progressed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Patients with pancreatic cancer who are failed of receiving first-line chemotherapy and cannot tolerate second-line chemotherapy or unwilling to receive second-line chemotherapy will receive Apatinib Tablets (850mg once daily, orally) 30 minutes after meal with warm water. Take 28 days as a cycle, patients will receive this treatment until they have got disease progressed. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS(Progression free survival) | 8 Weeks | |
| ORR (Objective response rate) | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| DCR(disease control rate) | 8 Weeks | |
| OS (Overall survival) | 8 Weeks | |
| QoL (Quality of life as assessed by EORTC QLQ-C30) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danfeng Dong, MD | Contact | 008615349257340 | qiwudanfeng@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Enxiao Li, MD | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First affiliate hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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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 |
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|
|
| 8 Weeks |
| Number of participants with treatment-related adverse events as assessed by NCI-CTC(V3.0) | 8 Weeks |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |