A Study of Irinotecan Liposome in Advanced Pancreatic Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04796948
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

To determine the safety and tolerability of irinotecan liposome in combination with oxaliplatin and 5-FU/LV in subjects with advanced pancreatic cancer who have not received prior systemic chemotherapy

Key Dates

Start date
Apr 8, 2021
Status verified
Apr 2025
Primary completion
Jun 28, 2024
Completion
Jun 28, 2024

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan liposome；oxaliplatin；5-FU(Fluorouracil Injection)；LV(Calcium Folinate Injection)
    1. irinotecan liposome: irinotecan liposome injection is irinotecan encapsulated in liposomes for i.v. infusion. 2. oxaliplatin: oxaliplatin is a sterile, aqueous solution; 50mg/vial. 3. 5-FU(Fluorouracil Injection): an aqueous, sterile, nonpyrogenic injectable solution available in 10ml/0.25g. 4. LV(Calcium Folinate Injection): be supplied in vials containing 10ml/0.1g and available as an injectable solution.

Primary Outcome Measure

MTD [ Time Frame: 18 months ]