RecruitingPhase 2NCT07146646

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

Sponsor

Case Comprehensive Cancer Center

Enrollment

27 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer Cholangiocarcinoma Gallbladder Cancer Biliary Tract Neoplasms Gallbladder Carcinoma

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).

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two chemotherapy drugs — trifluridine/tipiracil (TAS-102) and oxaliplatin — for people with advanced or metastatic biliary tract cancer (cancer of the bile ducts or gallbladder) who have already received one round of treatment. **You may be eligible if...** - You are older than 18 years - You have a confirmed diagnosis of advanced or metastatic biliary tract cancer (including cholangiocarcinoma or gallbladder carcinoma) - You have received exactly one prior line of treatment for advanced/metastatic disease - You have good physical functioning (ECOG performance status 0 or 1) - You have at least one measurable tumor **You may NOT be eligible if...** - You have ampullary cancer (a different type of cancer near the bile duct opening) - You have previously received TAS-102 or are unable to tolerate the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrifluridine/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.

DRUGOxaliplatin

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

Locations(2)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT07146646

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