mFOLFOX/mFOLFIRI vs mFOLFOX in advanced biliary tract cancer after first-line failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 randomized trial for patients with biliary tract cancers that are unresectable or have recurred after initial treatment. Eligible participants are assigned to either a single regimen of mFOLFOX every 2 weeks or an alternating regimen of mFOLFOX/mFOLFIRI every 2 weeks, with stratification by site and performance status. The study uses standard chemotherapy components (oxaliplatin, fluorouracil, leucovorin, and irinotecan in the combination arm) and requires measurable disease and adequate organ function. Primary goals focus on progression-free or overall response, while safety and tolerability are monitored per protocol. Geographic sites include several Korean hospitals coordinated by Seoul National University Bundang Hospital.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dong-A University Hospital
  Busan, Busan, South Korea Recruiting
• Keimyung University Dongsan Hospital
  Daegu, Daegu, South Korea Recruiting
• Gangneung Asan Hospital
  Gangneung, Gangwon-do, South Korea Recruiting
• CHA Bundang Medical Center
  Seongnam-si, Gyeonggi-do, South Korea Recruiting
• Gachon University Gil Medical Center
  Incheon, Incheon, South Korea Recruiting
• Chonnam National University Hwasun Hospital
  Hwasun, Jeollanam-do, South Korea Recruiting

Study contacts

• Study coordinator: Jin Won MD Kim, PhD
• Email: jwkim@snubh.org
• Phone: 82-31-787-7053

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Alternating chemo-immunotherapy and FGFR inhibitor for FGFR-positive biliary tract cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.