A Randomized Phase II Study of S-1 plus Leucovorin versus S-1 alone in Patients with Gemcitabine-Refractory Advanced Pancreatic Cancer.
Phase 2
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-jRCT2080221515
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
Patients must be diagnosed as invasive pancreatic ductal carcinoma
- Patients with gemcitabine-refractory
- Age: 20 years to 79 years
- Eastern Cooperetive Oncology Group (ECOG) performance status (PS) of 0 or 1
- Sufficient oral intake
- Written informed consent
Exclusion Criteria
- Diarrhea
- History or presence of severe pulmonary disease
- History or presence of severe heart disease
- Uncontrolled or severe diabetes
- Severe complications(e.g., severe enteritis, severe stomatitis, gastrointestinal ulcer)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method