mFOLFOX/mFOLFIRI vs. mFOLFOX in Advanced or Recurrent Biliary Tract Cancer Second-line (NCT07062536) | Clinical Trial Compass
Not Yet RecruitingPhase 2
mFOLFOX/mFOLFIRI vs. mFOLFOX in Advanced or Recurrent Biliary Tract Cancer Second-line
South Korea130 participantsStarted 2026-06-01
Plain-language summary
In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin,efficacy of mFOLFOX/FOLFIRI vs mFOLFOX will be evaluated at randomized phase 2 trial.
Who can participate
Age range
19 Years – 99 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
. Age ≥ 19 years.
. Diagnosed with biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, or ampulla of Vater cancer.
. Either unresectable advanced disease or recurrence after curative surgery.
. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2
. First-Line Treatment Failure: Disease progression after at least one cycle of gemcitabine/cisplatin-based therapy or discontinuation of therapy due to adverse effects.
. Presence of evaluable or measurable lesions according to RECIST v1.1 criteria.
. Laboratory Criteria: optima bone marrow, liver, and kidney function within one week prior to enrollment: A. Hemoglobin \> 9.0 g/dL B. Absolute neutrophil count (ANC) \> 1,000/uL C. Platelet count \> 75,000/uL D. Serum creatinine \< 1.5× upper limit of normal (ULN) E. AST/ALT \< 3× ULN F. Total bilirubin \< 1.5× ULN (biliary drainage is allowed).
. Patients who understand the study protocol, can provide written informed consent, and are aware of their right to withdraw at any time without penalty.
Exclusion criteria
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 is a Phase 2 trial comparing mFOLFOX to mFOLFOX/mFOLFIRI as a second-line treatment — does that mean there's still a lot of uncertainty about which combination is safer or more effective, and how should that affect my decision about joining?
2Since the trial is measuring the six-month overall survival rate as its main goal, what does that tell us about where the research currently stands, and how does that compare to what I might expect from standard second-line options available to me right now?
3The trial isn't recruiting yet — do you have a sense of when it might open, and is it worth waiting for it or should we be thinking about starting a second-line treatment sooner?
4Because this is a second-line study for advanced or metastatic biliary tract cancer, would I need to have already tried and not responded to a first-line therapy to even be considered, and does my treatment history so far fit that kind of requirement?
5Given that both mFOLFOX and mFOLFIRI are chemotherapy regimens with known side effect profiles, can you walk me through what the physical demands of either combination might look like week-to-week, and whether my current health could handle that kind of treatment schedule?
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.