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Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer

NCT07146646 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-02-19

No results posted yet for this study

Summary

Participants are eligible for this study who were treated for advanced biliary tract cancer (BTC) but the treatment either did not make the cancer better or is no longer working. The treatment for patients whose advanced BTC either did not make the cancer better or is no longer working is a combination of chemotherapy drugs called FOLFOX which consists of fluorouracil and oxaliplatin. Studies have shown that other treatments may work better to treat advanced BTC. In this study, investigators want to see if treating patients with the drug combination of trifluridine/tipiracil (FTD/TPI) and another drug called oxaliplatin works better than FOLFOX for advanced BTC as second-line therapy. FTD/TPI are pills that are taken by mouth, whereas oxaliplatin is given intravenously (by IV).

Conditions

  • Biliary Tract Cancer
  • Biliary Tract Neoplasms
  • Cholangiocarcinoma
  • Gallbladder Cancer
  • Gallbladder Carcinoma

Interventions

DRUG

Trifluridine/tipiracil

FTD/TPI will be taken by mouth on Days 1-5 of the 14-day treatment cycle. The starting does is 25mg/m2 twice per day.

DRUG

Oxaliplatin

Oxaliplatin is given on Day 1 of each 14-day cycle. It is given intravenously (by IV) over 2 hours.

Sponsors & Collaborators

Principal Investigators

  • Madison Conces, MD · Case Comprehensive Cancer Center, University Hospitals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-02-28
Completion
2027-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146646 on ClinicalTrials.gov