NCT07146646

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

A Phase II Trial of Trifluridine/Tipiracil Plus Oxaliplatin in Patients With Advanced or Metastatic Biliary Tract Cancer Following First-Line Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Detailed description

BTCs are difficult to treat. It is estimated that in the United States (US) approximately 15,000-20,000 people will be diagnosed with a BTC per year. In 2024, liver and intrahepatic bile duct cancers were the 5th leading cause of death from cancer among men and 7th among women in the US (1). Most people with BTCs have cancer that has spread or cannot be removed with surgery, so systemic treatments are the only option. However, the median survival after being diagnosed with an advanced BTC is still only 4.5 months, so it is important that we find better treatment options (2). This study is evaluating the combination of a medicine called trifluridine/tipiracil (FTD/TPI) and a medicine called oxaliplatin in treating advanced BTCs. While FTD/TPI has been used to treat other types of cancer, it is not yet approved to treat BTCs, so it is experimental. On the other hand, oxaliplatin is a medicine that has been previously used to treat BTCs.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-02-01
• Completion: 2027-04-01
• First posted: 2025-08-28
• Last updated: 2026-02-19

Locations

2 sites across 1 country: United States