A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBelgian Group of Digestive Oncology
About this trial
A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy
Eligibility criteria
Qualifiers
Histologically proven metastatic adenocarcinoma of the pancreas
Progression documented after gemcitabine-Abraxane, or gemcitabine monotherapy
Signed written informed consent
Age ≥ 18
Disqualifiers
Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months
Known hypersensitivity to any of the components, including excipients, of study treatments
Previous malignancy in the last past 3 years except basal cell cancer of the skin or preinvasive cancer of the cervix or carcinoma in situ of any type
Trial design
Treatments tested in this trial
- Nanoliposomal irinotecan
- 5 FU
- Leucovorin
- Oxaliplatin
Treatment groups
134 Participants
are divided into 2 treatment groupsSponsors and collaborators
Belgian Group of Digestive Oncology
Lead sponsor
University Hospital St Luc, Brussels
Collaborator
Source ClinicalTrials.gov