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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. Active uncontrolled infection, chronic infectious diseases, immune deficiency syndromes
✕. Premalignant hematologic disorders, e.g. myelodysplastic syndrome
✕. Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before enrollment
✕. 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

Progression-free survival [PFS]

Timeframe: approx. 25 months

NCT IDNCT03044587

SponsorAIO-Studien-gGmbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-01

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. Active uncontrolled infection, chronic infectious diseases, immune deficiency syndromes
✕. Premalignant hematologic disorders, e.g. myelodysplastic syndrome
✕. Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before enrollment
✕. 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