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

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
Updated on 3 July 2021


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.

Condition Metastatic Adenocarcinoma of the Pancreas
Treatment Gemcitabine, Oxaliplatin, Nab-paclitaxel, Leucovorin, 5Fluorouracil, Irinotecan Liposomal Injection
Clinical Study IdentifierNCT04083235
Last Modified on3 July 2021


Yes No Not Sure

Inclusion Criteria

Histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting
Initial diagnosis of metastatic disease must have occurred 6 weeks prior to screening
Subject has one or more metastatic tumours measurable by computed tomography (CT) scan (or magnetic resonance imaging (MRI), if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Subject has adequate biological parameters as demonstrated by the following blood counts:(a) Absolute neutrophil count (ANC) 2000/mm3 without the use of hemopoietic growth factors within the last 7 days prior to randomisation (b) Platelet count 100,000/mm3 (c) Haemoglobin (Hgb) 9 g/dL obtained 14 days prior to randomisation
Adequate hepatic function as evidenced by: (a) Serum total bilirubin 1.5x ULN (biliary drainage is allowed for biliary obstruction), and (b) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5x upper limit of normal (ULN) (5x ULN is acceptable if liver metastases are present)
Adequate renal function as evidenced by creatinine clearance 30 mL/min
Adequate coagulation studies (obtained 14 days prior to randomisation) as demonstrated by prothrombin time and partial thromboplastin time within normal limits (1.5xULN )

Exclusion Criteria

Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy
Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present
Subject has only localised advanced disease
Documented serum albumin <3 g/dL
Known history of central nervous system (CNS) metastases
Clinically significant gastrointestinal disorder
History of any second malignancy in the last 2 years
Concurrent illnesses that would be a relative contraindication to trial participation
Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1
Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
Known low or absent dihydropyrimidine dehydrogenase (DPD) activity
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note