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Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT07146646•Case Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must have histologically or cytologically confirmed biliary tract cancer (BTC) including cholangiocarcinoma and gallbladder carcinoma. Individuals with ampullary cancers will not be considered eligible. Cancer must be advanced stage or metastatic.
•Participants must have received only one line of systemic therapy for advanced or metastatic BTCs.
•Note: Individuals who have either progressed or are intolerant to the prior therapy can be included in this study.
•Age \>18 years on day of signing informed consent. Because no dosing or adverse event data are currently available on the use of FTD/TPI in individuals ≤18 years of age, children are excluded from this study.
•Performance status: ECOG performance status of 0 or 1.
•At least one index lesion is measurable based on RECIST 1.1.
•Participants must have organ and marrow function as defined below:
•* Absolute neutrophil count ≥ 1,500/mcL
•* Platelet count ≥75,000/mcL
•* AST (SGOT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases
+6 more criteria

Exclusion Criteria

•Participants receiving any other investigational agents.
•Participant has received investigational therapy within 4 weeks or within 5 half-lives of the therapeutic agent (whichever is shorter).
•Received more than one line of systemic therapy for bile duct cancer. Adjuvant therapy will not be counted as line of systemic therapy.
•Receiving systemic steroid therapy (\>10mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•Prior treatment with FTD/TPI or oxaliplatin.
•Known additional malignancy that currently requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has already undergone potentially curative therapy.
•Known central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable without evidence of new or enlarging brain metastases and are not using steroids for at least 7 days prior to trial treatment.
•Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (\> 10 mg/day or equivalent of prednisone) or immunosuppressive agents. (thyroid disease and diabetes are allowed)
•Interstitial lung disease or active, non-infectious pneumonitis.
•Active infection requiring systemic antibiotics.
+4 more criteria

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

Key Dates

Start Date

December 1, 2025

Primary Completion Date

February 1, 2027

Completion Date

April 1, 2027

Last Updated

February 19, 2026

Enrollment

ESTIMATED participants

Conditions

Biliary Tract CancerBiliary Tract NeoplasmsCholangiocarcinomaGallbladder CancerGallbladder Carcinoma

Interventions

Trifluridine/tipiracil

DRUG

Oxaliplatin

DRUG

Contacts

Madison Conces, MD

CONTACT

216-844-3951 Madison.Conces@UHhospitals.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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