Could alternating chemo drugs boost survival in biliary cancer?
NCT ID NCT07062536
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether alternating between two chemotherapy regimens (mFOLFOX and mFOLFIRI) works better than using just one (mFOLFOX) as a second-line treatment for advanced biliary tract cancer. The study will enroll 130 adults whose cancer has progressed after first-line treatment. The main goal is to see if the alternating approach improves 6-month survival rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy drugs (oxaliplatin, 5FU, leucovorin, irinotecan)
- What this could lead to
- If successful, this could offer a more effective second-line chemotherapy option for people with advanced biliary tract cancer, potentially improving survival.
- What could go wrong
- This is a phase 2 trial with only 130 participants, so results are preliminary. Chemotherapy has significant side effects, and the alternating regimen may not prove better than standard treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria (All eligibility criteria must be fulfilled) 1. Age ≥ 19 years. 2. Diagnosed with biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, or ampulla of Vater cancer. 3. Either unresectable advanced disease or recurrence after curative surgery. 4. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 5. First-Line Treatment Failure: Disease progression after at least one cycle of gemcitabine/cisplatin-based therapy or discontinuation of therapy due to adverse effects. 6. Presence of evaluable or measurable lesions according to RECIST v1.1 criteria. 7. 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). 8. Patients who understand the study protocol, can provide written informed consent, and are aware of their right to withdraw at any time without penalty. 9. Effective Contraception (for patients of childbearing potential receiving oxaliplatin): A. Male patients: Must use effective contraception during the study and for 12 months after treatment completion. B. Female patients: Must use effective contraception during the study and for 15 months after treatment completion. \*Exclusion Criteria (Patients meeting any of the following criteria will be excluded from the study.) 1. Patients with prior exposure to oxaliplatin or irinotecan in previous cancer treatments. 2. Patients with metastatic or unresectable biliary tract cancer who have received second- line or higher chemotherapy. 3. Pregnant or breastfeeding women. 4. Patients with a history of other malignancies within the past 3 years, except for papillary or follicular thyroid cancer. 5. Patients with uncontrolled infections or other systemic diseases. 6. Patients with a history of myocardial infarction, unstable angina, or heart failure (NYHA 7. Class III-IV) within the last 6 months. 8. Patients with Grade 3 or higher peripheral neuropathy caused by prior chemotherapy. 9. Patients with known allergic reactions to the investigational drugs. 10. Known patients with Gilbert's syndrome, DPD (dihydro-pyrimidine dehydrogenase) deficiency, or Homozygous UGT1A1\*28 alleles. 11. Patients currently taking potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin), or potent CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John's Wort). 12. Patients who are eligible for targeted therapy, including FGFR inhibitors or IDH1 inhibitors. (eligible for patient who unable to use these targeted agents due to drug cost.) 13. Patients with active CNS metastases and/or carcinomatous meningitis. 14. Patients who meet contraindications for the investigational drugs as per domestic regulatory guidelines, including patients with infections, Interstitial pneumonitis or pulmonary fibrosis, Severe diarrhea, Chronic inflammatory bowel disease, Intestinal paralysis or obstruction, Functional impairment due to peripheral sensory neuropathy, Severe renal dysfunction. 15. Patients deemed ineligible by the investigator for any other reason.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asan Medical Center
RECRUITINGSeoul, Seoul, 05505, South Korea
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CHA Bundang Medical Center
RECRUITINGSeongnam-si, Gyeonggi-do, 13496, South Korea
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Chonnam National University Hwasun Hospital
RECRUITINGHwasun, Jeollanam-do, 58128, South Korea
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Chungbuk National University Hospital
RECRUITINGCheongju-si, North Chungcheong, 28644, South Korea
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Dong-A University Hospital
RECRUITINGBusan, Busan, 49201, South Korea
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Gachon University Gil Medical Center
RECRUITINGIncheon, Incheon, 21565, South Korea
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Gangneung Asan Hospital
RECRUITINGGangneung, Gangwon-do, 25457, South Korea
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Keimyung University Dongsan Hospital
RECRUITINGDaegu, Daegu, 42601, South Korea
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Seoul Metropolitan Government Seoul National University Boramae MedicalCenter
RECRUITINGSeoul, Seoul, 07061, South Korea
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Seoul National University Bundang Hospital
RECRUITINGSeongnam-si, Out of US, 13605, South Korea
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Yonsei University Health System, Severance Hospital
RECRUITINGSeoul, Seoul, 03722, South Korea
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