NaliCap (Irinotecan Liposome (Nal-IRI)/Capecitabine) vs. NAPOLI (Nal-IRI/5-FU/LV) ) in Advanced Pancreatic Cancer
NCT04371224 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2024-04-19
Summary
This is an open label, randomized phase 2 study of NaliCap (irinotecan liposome/Capecitabine) compared to NAPOLI (irinotecan liposome/5-FU/LV) in gemcitabine-pretreated advanced pancreatic cancer patients.
Conditions
Interventions
- DRUG
-
Irinotecan Liposomal Injection [Onivyde]
both arm
- DRUG
-
NaliCap
- DRUG
-
NAPOLI
- DRUG
-
NAPOLI
Sponsors & Collaborators
-
Seoul National University Hospital
lead OTHER
Principal Investigators
-
Do-Youn Oh, M.D., PhD. · Seoul National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-23
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
Countries
- South Korea
Study Locations
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