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

No results posted yet for this study

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

Capecitabine

NaliCap

DRUG

5-fluorouracil

NAPOLI

DRUG

Leucovorin

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04371224 on ClinicalTrials.gov