SC-104
Phase 3
Completed
- Conditions
- ntreated local advanced or distant metastatic pancreatic cancer
- Registration Number
- JPRN-jRCT2080221441
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
1) Patients with untreated non-resectable local advanced or distant metastatic pancreatic cancer diagnosed by the pathological examination.
2) ECOG 0 or 1.
3) Patients with good bone marrow, liver and renal functions.
4) Patients who provided the written informed consent.
Exclusion Criteria
1) Patients with diarrhea of CTCAE Grade 2 or above.
2) Patients with severe complications, brain metastases, multiple carcinoma, or active infection.
3) Patients with active pleural fluid or ascites.
4) Pregnancy and breast-feeding women or cases with a child-bearing plan.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival<br>Kaplan-Meier method is used for OS of FAS.
- Secondary Outcome Measures
Name Time Method Safety, Objective Response Rate, Progression-Free Survival, Clinical Benefit Rate, QOL, Change of Pain, Change of Body Weight<br>RECIST, CTCAE