RecruitingPhase 2NCT07062536

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

Sponsor

Seoul National University Bundang Hospital

Enrollment

130 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

Biliary Cancer Metastatic

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.

Eligibility

Min Age: 19 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Oxaliplatin, 5FU, leucovorin and a drug called Oxaliplatin, 5FU, leucovorin/Irinotecan , 5FU, leucovorin, for people with biliary cancer metastatic. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 19 Years to 99 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOxaliplatin, 5FU, leucovorin

Administered as a single regimen every 2weeks

DRUGOxaliplatin, 5FU, leucovorin/Irinotecan , 5FU, leucovorin,

Administered alternately every 2weeks

Locations(11)

Dong-A University Hospital

Busan, Busan, South Korea

Keimyung University Dongsan Hospital

Daegu, Daegu, South Korea

Gangneung Asan Hospital

Gangneung, Gangwon-do, South Korea

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, Incheon, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Out of US, South Korea

Yonsei University Health System, Severance Hospital

Seoul, Seoul, South Korea

Asan Medical Center

Seoul, Seoul, South Korea

Seoul Metropolitan Government Seoul National University Boramae MedicalCenter

Seoul, Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT07062536