QYHJ Granules Versus Xeloda in Metastatic Pancreatic Cancer
NCT01796782 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2013-02-22
Summary
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.
Conditions
Interventions
- DRUG
-
Xeloda
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
- DRUG
-
QYHJ Granules
1-4 bags bid , days 1-42, every 6 weeks
Sponsors & Collaborators
-
Fudan University
lead OTHER
Principal Investigators
-
zhen Chen, M.D. · Fudan University
-
lu ming Liu, M.D. · Fudan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2015-08-31
- Completion
- 2015-12-31
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