Trials / Unknown
UnknownNCT01796782
QYHJ Granules Versus Xeloda in Metastatic Pancreatic Cancer
A Prospective, Randomized, Open-label, Phase II Study of QYHJ Granules Versus Xeloda in the Second-line Treatment of Patients With Metastatic Pancreatic Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2015-08-01
- Completion
- 2015-12-01
- First posted
- 2013-02-22
- Last updated
- 2013-02-22
Source: ClinicalTrials.gov record NCT01796782. Inclusion in this directory is not an endorsement.