Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Bilia… (NCT03044587) | Clinical Trial Compass
CompletedPhase 2
Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer
Germany93 participantsStarted 2018-01-24
Plain-language summary
AIO-YMO/HEP-0315 (NIFE) is an open label, non-comparative, randomized, multicenter phase II trial
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent incl. participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
. Age ≥ 18 years at time of study entry
. Histologically confirmed, non-resectable, locally advanced or metastatic adenocarcinoma of the intrahepatic or extrahepatic biliary tract
. Protocol-specific staging guidelines have to be observed and non-resectability has to be confirmed by local tumor board
. Measurable or assessable disease according to RECIST 1.1
. ECOG performance status 0-1
. Life expectancy of more than 3 months
. If applicable, adequately treated biliary tract obstruction before study entry with total bilirubin concentration ≤ 2 x ULN
Exclusion criteria
. Active uncontrolled infection, chronic infectious diseases, immune deficiency syndromes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared nal-IRI with 5-FU and leucovorin against gemcitabine plus cisplatin for biliary tract cancer — since the trial is now completed, has any published data emerged showing which regimen helped patients go longer without their cancer progressing, and where does that leave me in terms of treatment options today?
2Because this was a Phase 2 trial focused on progression-free survival, what does that mean about how much we actually know regarding long-term survival or overall safety compared to what a larger Phase 3 trial would tell us?
3Gemcitabine plus cisplatin is currently a standard first-line treatment for advanced biliary tract cancer — given the results of this completed trial, would you recommend I consider that standard regimen first, or is there a reason the nal-IRI combination might be worth pursuing in my specific case?
4Since this trial enrolled patients with several different types of biliary tract cancer including intrahepatic and extrahepatic bile duct carcinoma, does the specific type and location of my cancer affect how relevant the results of this trial might be to my situation?
5Now that this trial has completed, are there any follow-on Phase 3 trials or newer studies building on these findings that you think might be worth exploring alongside or instead of the treatments tested here?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Prior (\>5 years) or concurrent malignancy (other than biliary-tract cancer) which either progresses or requires active treatment. Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial bladder tumor \[Ta, Tis and T1\].
. Pre-existing lung disease
. History or clinical evidence of CNS metastases
. are asymptomatic and
. have no requirement for steroids 6 weeks prior to start of study treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS metastases