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)

Study Timeline

• Study First Submitted: 2025-02-20
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Study Start: 2025-08-01
• Primary Completion: 2027-04-01
• Study Completion: 2028-04-01

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

Group	Intervention	Description
mFOLFOX	Oxaliplatin, 5FU, leucovorin	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
mFOLFOX/mFOLFIRI	Oxaliplatin, 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

Name	Time	Method
6months overall survival rate	6months	at 6months from intervention treatment, overall survival rate

Secondary Outcome Measures

Name	Time	Method
response rate	6months	complete response,partial response
disease control rate	6month	complete response, partial response, stable disease
progression free survival	6month	from treatment start to progression or any cause of death
Number of participants with Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0	6month	percentage of all patients

Trial Locations

Locations (1)

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