A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
Public ClinicalTrials.gov record NCT04083235. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
Study identification
- NCT ID
- NCT04083235
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 770 participants
Conditions and interventions
Conditions
Interventions
- Irinotecan Liposomal Injection Drug
- Oxaliplatin Drug
- 5Fluorouracil Drug
- Leucovorin Drug
- Nab-paclitaxel Drug
- Gemcitabine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 11, 2020 (Actual)
- Primary completion
- Jul 23, 2022 (Actual)
- Completion
- Feb 18, 2025 (Actual)
- Last update posted
- Apr 20, 2026
2020 – 2025
United States locations
- U.S. sites
- 72
- U.S. states
- 31
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Banner Health- MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| Mayo Clinic - Scottsdale | Phoenix | Arizona | 85054 | — |
| Comprehensive Blood And Cancer Center | Bakersfield | California | 93309 | — |
| University of California- Irvine Health Cancer Cente | Costa Mesa | California | 92627 | — |
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| University of California, Los Angeles (UCLA) | Los Angeles | California | 90095 | — |
| St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare | Orange | California | 92835 | — |
| University of California - Irvine Medical Center | Orange | California | 92868 | — |
| Torrance Memorial Physician Network Cancer Care | Redondo Beach | California | 90277 | — |
| Sutter Health Sacramento | Sacramento | California | 95816 | — |
| Presbyterian Intercommunity Hospital (PIH) | Whittier | California | 90602 | — |
| UC Health Memorial Hospital | Colorado Springs | Colorado | 80909 | — |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | — |
| Miami Cancer Institute | Miami | Florida | 33176 | — |
| Mount Sinai Medical Center of Florida, Inc. | Miami Beach | Florida | 33140 | — |
| Florida Cancer Specialists - Fort Myers | Sarasota | Florida | 34236 | — |
| Florida Cancer Specialists - Panhandle | Tallahassee | Florida | 32308 | — |
| Florida Cancer Specialists - St. Petersburg | Tampa | Florida | 33607 | — |
| Florida Cancer Specialists - East | West Palm Beach | Florida | 33401 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Edward Hospital - Elmhurst | Elmhurst | Illinois | 60540 | — |
| Illinois CancerCare - Peoria | Peoria | Illinois | 61443 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46804 | — |
| Siouxland Hematology - Oncology Associates, LLP | Sioux City | Iowa | 51101 | — |
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Pikeville Medical Center | Pikeville | Kentucky | 41501 | — |
| Hematology Oncology Clinic | Baton Rouge | Louisiana | 70809 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Willis-Knighton Cancer Center | Shreveport | Louisiana | 71103 | — |
| Maine Center for Cancer Medicine | Scarborough | Maine | 04074 | — |
| Maryland Oncology Hematology | Silver Spring | Maryland | 20904 | — |
| Beth Israel Deaconess | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49546 | — |
| Health Partners Institute | Minneapolis | Minnesota | 55425 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55902 | — |
| Research Medical Center | Kansas City | Missouri | 64132 | — |
| Frontier Cancer Center | Billings | Montana | 59102 | — |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| Clinical Research Alliance, Inc | Lake Success | New York | 10021 | — |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| Messino Cancer Center | Asheville | North Carolina | 28806 | — |
| The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James) | Columbus | Ohio | 43210 | — |
| Toledo Clinic Cancer Center | Toledo | Ohio | 43623 | — |
| University of Oklahoma - Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Oncology Associates of Oregon | Eugene | Oregon | 97401 | — |
| Compass Oncology - Rose Quarter Cancer Center | Portland | Oregon | 97227 | — |
| Kaiser Permanente - Northwest | Portland | Oregon | 97227 | — |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | — |
| University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Greenville Hospital System | Greenville | South Carolina | 29605 | — |
| Chattanooga Oncology Hematology Care - Tennessee Oncology | Chattanooga | Tennessee | 37404 | — |
| The West Cancer Center | Memphis | Tennessee | 38138 | — |
| Sarah Cannon and HCA Research Institute | Nashville | Tennessee | 37203 | — |
| Texas Oncology - Austin | Austin | Texas | 78731 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Houston Methodist Research Institute | Houston | Texas | 77030 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Oncology Consultants | Houston | Texas | 77030 | — |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| Texas Oncology - Wichita Falls | Wichita Falls | Texas | 76310 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Blue Ridge Cancer Care | Wytheville | Virginia | 24014 | — |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 128 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04083235, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 20, 2026 · Synced Oct 16, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04083235 live on ClinicalTrials.gov.