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

Sponsor
Seoul National University Bundang Hospital
Study ID
NCT07062536
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Biliary Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
19 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jul 14, 2025
Start date
Aug 27, 2025
Status verified
Aug 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: mFOLFOX
    1\) mFOLFOX (Administered as a single regimen every 2weeks) D1 Oxaliplatin 85mg/m2 over 2hr Leucovorin 400mg/m2 over 2hr Fluorouracil 400mg/m2 FU 2400mg/m2 over 46hr
  • Experimental: 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

Primary Outcome Measure

6months overall survival rate [ Time Frame: 6months ]

Central Contacts