A One-Arm Exploratory Clinical Trial of Apatinib Plus Gemcitabine in Patients With Advanced Metastatic Pancreatic Cancer (OECTAPGAMPC)
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|ClinicalTrials.gov Identifier: NCT02863367|
Recruitment Status : Unknown
Verified July 2016 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was: Not yet recruiting
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Cancer||Drug: Apatinib Drug: Gemcitabine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A One-Arm Exploratory Clinical Trial of Apatinib Plus Gemcitabine in Patients With Advanced Metastatic Pancreatic Cancer|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Treatment group
Apatinib：500 mg，po，qd, d1-14, every 3 week Gemcitabine：1000mg/m²，vein input 30-40，d1，d8，every 3 week
Apatinib：500 mg，po，qd, d1-14, every 3 week
Other Name: YN968D1
Gemcitabine：1000mg/m²，vein input 30-40，d1，d8，every 3 week
- Objective Response Rate (ORR) [ Time Frame: 1 years ]
- progression-free survival (PFS) [ Time Frame: 1 years ]
- Overall Survival (OS) [ Time Frame: 1 years ]
- Life Quality Score (QoL) [ Time Frame: 1 years ]
- Disease Control Rate (DCR) [ Time Frame: 1 years ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 years ]
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): NCT02863367
|Contact: Hao Ji Hui, PhD||022-23340123 ext email@example.com|
|Contact: Ren He, PhD||022-23340123 ext firstname.lastname@example.org|
|Principal Investigator:||Hao Ji Hui, PhD||National Clinical Research Center for Cancer of China|