NCT07062536

mFOLFOX/mFOLFIRI vs. mFOLFOX in Advanced or Recurrent Biliary Tract Cancer Second-line

A Randomized Phase II Clinical Trial to Evaluate the Efficacy Alternating mFOLFOX/mFOLFIRI Chemotherapy Regimen as a Second-line Treatment for Advanced Biliary Tract Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1. brief enrollment criteria * histological confirmed * refractory to first line gemcitabine plus cisplatin * fit for chemotherapy 2. treatment arm A. mFOLFOX (Administered as a single regimen every 2weeks) 1) mFOLFOX D1 Oxaliplatin 85mg/m2 over 2hr Leucovorin 400mg/m2 over 2hr Fluorouracil 400mg/m2 FU 2400mg/m2 over 46hr treatment arm B. mFOLFOX/mFOLFIRI (Administered alternately every 2 weeks.) 1) mFOLFOX D1 Oxaliplatin 85mg/m2 over 2hr Leucovorin 400mg/m2 over 2hr Fluorouracil 400mg/m2 FU 2400mg/m2 over 46hr 2) mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr 3. randomization - stratified by site and performance status * Previous cancer treatment (including IO agents vs. excluding IO agents)

Conditions

• Biliary Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Oxaliplatin, 5FU, leucovorin	Administered as a single regimen every 2weeks
DRUG	Oxaliplatin, 5FU, leucovorin/Irinotecan , 5FU, leucovorin,	Administered alternately every 2weeks

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2025-07-14
• Last updated: 2025-07-14

Locations

1 site across 1 country: South Korea