QYHJ Granules Versus Xeloda in Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01796782|
Recruitment Status : Unknown
Verified February 2013 by liu lu ming, Fudan University.
Recruitment status was: Active, not recruiting
First Posted : February 22, 2013
Last Update Posted : February 22, 2013
Primary End Point:
- To compare the overall survival (OS) using QYHJ Granules or Xeloda as the second therapy in patients with metastatic pancreatic cancer.
Secondary End Points:
- Compare clinical efficacy by other measures including PFS,tumor response,and changes in quality of life (QOL) between these two groups.
- Examine the feasibility and assess the side effects of treatment using QYHJ Granules in patients with metastatic pancreatic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Cancer||Drug: Xeloda Drug: QYHJ Granules||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Open-label, Phase II Study of QYHJ Granules Versus Xeloda in the Second-line Treatment of Patients With Metastatic Pancreatic Cancer|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||December 2015|
Active Comparator: Xeloda
Subjects will receive Xeloda until progression
Xeloda dose is calculated according to body surface area.The recommended dose is 1000 mg/m² administered orally twice daily (morning and evening; equivalent to 2000 mg/m² total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles
Other Name: Capecitabine
Experimental: QYHJ Granules
patients will receive QYHJ Granules until progression
Drug: QYHJ Granules
1-4 bags bid , days 1-42, every 6 weeks
- overall survival (OS) [ Time Frame: up to 3 years ]
- Progression free survival（PFS） [ Time Frame: up to 3 years ]
- Tumor response（ORR、DCR） [ Time Frame: up to 3 years ]
- Clinical benefit rate （CBR）and QOL assessment [ Time Frame: up to 3 years ]
- Number of adverse events of QYHJ Formula [ Time Frame: up to 3 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): NCT01796782
|Principal Investigator:||zhen Chen, M.D.||Fudan University|
|Study Director:||lu ming Liu, M.D.||Fudan University|