Apatinib as Second-line Treatment of Advanced Pancreatic Cancer (Apslpanc)
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|ClinicalTrials.gov Identifier: NCT02726854|
Recruitment Status : Unknown
Verified November 2016 by First Affiliated Hospital Xi'an Jiaotong University.
Recruitment status was: Recruiting
First Posted : April 4, 2016
Last Update Posted : December 2, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms||Drug: Apatinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Apatinib as Second-line Treatment of Advanced Pancreatic Cancer, Phase II Clinical Study of Open Arm|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Patients will be offered with Apatinib (850mg daily,orally)until their disease have progressed.
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.
Other Name: YN968D1
- PFS(Progression free survival) [ Time Frame: 8 Weeks ]
- ORR (Objective response rate) [ Time Frame: 8 Weeks ]
- DCR(disease control rate) [ Time Frame: 8 Weeks ]
- OS (Overall survival) [ Time Frame: 8 Weeks ]
- QoL (Quality of life as assessed by EORTC QLQ-C30） [ Time Frame: 8 Weeks ]
- Number of participants with treatment-related adverse events as assessed by NCI-CTC（V3.0） [ Time Frame: 8 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726854
|Contact: Danfeng Dong, MDemail@example.com|
|First affiliate hospital of Xi'an Jiaotong University||Recruiting|
|Xi'an, Shaanxi, China, 710061|
|Contact: , China 2982655038|
|Study Chair:||Enxiao Li, MD||First Affiliated Hospital Xi'an Jiaotong University|