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

NCT07062536 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Art-BTC
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Cancer Metastatic

Keywords

second line; alternating mFOLFOX/mFOLFIRI chemotherapy regimen

Outcome Measures

Primary Outcomes (1)

• 6months overall survival rate

  at 6months from intervention treatment, overall survival rate

  6months

Secondary Outcomes (4)

• response rate

  6months

• disease control rate

  6month

• progression free survival

  6month

• Number of participants with Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0

  6month

Study Arms (2)

mFOLFOX

EXPERIMENTAL

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

Drug: Oxaliplatin, 5FU, leucovorin

mFOLFOX/mFOLFIRI

EXPERIMENTAL

(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

Drug: Oxaliplatin, 5FU, leucovorin/Irinotecan , 5FU, leucovorin,

Interventions

Oxaliplatin, 5FU, leucovorin DRUG

Administered as a single regimen every 2weeks

Also known as: mFOLFOX

mFOLFOX

Oxaliplatin, 5FU, leucovorin/Irinotecan , 5FU, leucovorin, DRUG

Administered alternately every 2weeks

Also known as: mFOLFOX/mFOLFIRI

mFOLFOX/mFOLFIRI

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years.
• Diagnosed with biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, or ampulla of Vater cancer.
• Either unresectable advanced disease or recurrence after curative surgery.
• ECOG (Eastern Cooperative Oncology Group) performance status of 0-2
• First-Line Treatment Failure: Disease progression after at least one cycle of gemcitabine/cisplatin-based therapy or discontinuation of therapy due to adverse effects.
• Presence of evaluable or measurable lesions according to RECIST v1.1 criteria.
• Laboratory Criteria: optima bone marrow, liver, and kidney function within one week prior to enrollment: A. Hemoglobin \> 9.0 g/dL B. Absolute neutrophil count (ANC) \> 1,000/uL C. Platelet count \> 75,000/uL D. Serum creatinine \< 1.5× upper limit of normal (ULN) E. AST/ALT \< 3× ULN F. Total bilirubin \< 1.5× ULN (biliary drainage is allowed).
• Patients who understand the study protocol, can provide written informed consent, and are aware of their right to withdraw at any time without penalty.
• Effective Contraception (for patients of childbearing potential receiving oxaliplatin):
• A. Male patients:
• Must use effective contraception during the study and for 12 months after treatment completion.
• B. Female patients:
• Must use effective contraception during the study and for 15 months after treatment completion.

You may not qualify if:

• Patients with prior exposure to oxaliplatin or irinotecan in previous cancer treatments.
• Patients with metastatic or unresectable biliary tract cancer who have received second- line or higher chemotherapy.
• Pregnant or breastfeeding women.
• Patients with a history of other malignancies within the past 3 years, except for papillary or follicular thyroid cancer.
• Patients with uncontrolled infections or other systemic diseases.
• Patients with a history of myocardial infarction, unstable angina, or heart failure (NYHA
• Class III-IV) within the last 6 months.
• Patients with Grade 3 or higher peripheral neuropathy caused by prior chemotherapy.
• Patients with known allergic reactions to the investigational drugs.
• Known patients with Gilbert's syndrome, DPD (dihydro-pyrimidine dehydrogenase) deficiency, or Homozygous UGT1A1\*28 alleles.
• Patients currently taking potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin), or potent CYP3A4 inducers (e.g., rifampin, carbamazepine, St.
• John's Wort).
• Patients who are eligible for targeted therapy, including FGFR inhibitors or IDH1 inhibitors. (eligible for patient who unable to use these targeted agents due to drug cost.)
• Patients with active CNS metastases and/or carcinomatous meningitis.
• Patients who meet contraindications for the investigational drugs as per domestic regulatory guidelines, including patients with infections, Interstitial pneumonitis or pulmonary fibrosis, Severe diarrhea, Chronic inflammatory bowel disease, Intestinal paralysis or obstruction, Functional impairment due to peripheral sensory neuropathy, Severe renal dysfunction.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Jin Won Kim

Seongnam-si, Out of US, 13605, South Korea

Location

MeSH Terms

Interventions

Oxaliplatin; Fluorouracil; Leucovorin; Irinotecan

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids

Study Officials

• Sun A Han

  Seoul National University Bundang Hospital

  STUDY DIRECTOR

Central Study Contacts

Jin Won MD Kim, PhD

CONTACT

82-31-787-7053; jwkim@snubh.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Assignment

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: July 14, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)