NaliCap (Irinotecan Liposome (Nal-IRI)/Capecitabine) vs. NAPOLI (Nal-IRI/5-FU/LV) ) in Advanced Pancreatic Cancer

Sponsor
Seoul National University Hospital
Study ID
NCT04371224
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 23, 2020
Status verified
Apr 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NaliCap
    nal-IRI/Capecitabine
  • Active Comparator: NAPOLI
    nal-IRI/5-FU/LV

Primary Outcome Measure

Progression-free survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months ]

Central Contacts

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