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

Not Applicable
Not yet recruiting
Conditions
Biliary Cancer Metastatic
Interventions
Drug: Oxaliplatin, 5FU, leucovorin
Drug: Oxaliplatin, 5FU, leucovorin/Irinotecan , 5FU, leucovorin,
Registration Number
NCT07062536
Lead Sponsor
Seoul National University Bundang Hospital
Brief 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)

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
130
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
mFOLFOXOxaliplatin, 5FU, leucovorin1) 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
mFOLFOX/mFOLFIRIOxaliplatin, 5FU, leucovorin/Irinotecan , 5FU, leucovorin,(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 Measures
NameTimeMethod
6months overall survival rate6months

at 6months from intervention treatment, overall survival rate

Secondary Outcome Measures
NameTimeMethod
response rate6months

complete response,partial response

disease control rate6month

complete response, partial response, stable disease

progression free survival6month

from treatment start to progression or any cause of death

Number of participants with Treatment-Related Adverse Events as Assessed by NCI CTC version 4.06month

percentage of all patients

Trial Locations

Locations (1)

Jin Won Kim

🇰🇷

Seongnam-si,, Out Of US, Korea, Republic of

Jin Won Kim
🇰🇷Seongnam-si,, Out Of US, Korea, Republic of

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