Study on Trifluridine/Tipiracil and Oxaliplatin for Advanced Biliary Tract Cancer

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07146646

Provider View

This clinical trial is testing a new combination of drugs, trifluridine/tipiracil (FTD/TPI) and oxaliplatin, to see if it works better than the current standard treatment for advanced biliary tract cancer (BTC) that has not improved with previous therapy.

Patient Parameters

Program Overview

This study is exploring whether a new drug combination, trifluridine/tipiracil (FTD/TPI) taken as pills and oxaliplatin given by IV, can better treat advanced biliary tract cancer (BTC) compared to the standard chemotherapy treatment. The trial is for patients whose cancer has not improved with previous treatments or has stopped responding to them.

Description

Biliary tract cancers (BTCs) are challenging to treat, and many patients have cancer that has spread or cannot be removed with surgery. In the United States, about 15,000-20,000 people are diagnosed with BTC each year. The current standard treatment for advanced BTC is a chemotherapy combination called FOLFOX, but it only helps for a limited time. This study is testing a new combination of drugs, trifluridine/tipiracil (FTD/TPI) and oxaliplatin, to see if it can improve outcomes for patients with advanced BTC. While oxaliplatin has been used for BTC before, FTD/TPI is still experimental for this type of cancer. The goal is to find better treatment options for patients with advanced BTC.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of advanced or metastatic biliary tract cancer (BTC), including cholangiocarcinoma and gallbladder carcinoma.
  • Must have received only one previous treatment for advanced or metastatic BTC.
  • Cancer must have either progressed or the patient cannot tolerate the previous treatment.
  • Must be 18 years or older.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have at least one measurable tumor.
  • Must have adequate organ and bone marrow function, as shown by specific blood test results.
  • Must have recovered from any major surgery before starting the study treatment.
  • Must be able to understand and sign a consent form.
  • Must agree to use effective contraception during the study.

Exclusion Criteria

  • Currently receiving any other experimental treatments.
  • Have received experimental therapy within the last 4 weeks.
  • Have had more than one previous treatment for bile duct cancer.
  • Currently taking systemic steroids or other immunosuppressive medications.
  • Have been treated with FTD/TPI or oxaliplatin before.
  • Have another active cancer that requires treatment, except for certain skin cancers or cervical cancer that has been treated.
  • Have cancer that has spread to the brain or spinal cord, unless previously treated and stable.
  • Have an active autoimmune disease requiring treatment in the past 3 months.
  • Have lung disease or active lung inflammation.
  • Have an active infection needing antibiotics.
  • Have any condition or treatment that might interfere with the study.
  • Have psychiatric or substance abuse issues that would affect participation.
  • Have uncontrolled health issues like heart failure or unstable heart conditions.
  • Are pregnant or breastfeeding, or planning to conceive during the study and for 5 months after the last treatment.

Locations

FACILITYZIPCITYSTATE
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center44106ClevelandOhio
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center44195ClevelandOhio

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