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

NCT07146646 | Recruiting Phase 2 DMC

• 1 other identifier: CASE2225
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief 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; Gallbladder Cancer; Gallbladder Carcinoma; Cholangiocarcinoma

Keywords

Trifluridine/tipiracil; FTD/TPI; Oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Disease control rate (DCR) by RECIST v1.1

  DCR is the percentage of participants whose cancer did not get worse after treatment (i.e. the percentage of participants who had CR, PR, or SD, as defined below), and this will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

  Every 8 weeks until treatment discontinuation, up to 6 months

Secondary Outcomes (12)

• Safety and tolerability

  Day 1

• Safety and tolerability

  At treatment discontinuation, up to 6 months

• Safety and tolerability

  30 days post-study treatment discontinuation, up to 6 months

• Safety and tolerability

  Day 1

• Safety and tolerability

  At treatment discontinuation, up to 6 months

Study Arms (1)

FTD/TPI plus oxaliplatin

EXPERIMENTAL

Participants will complete 14-day treatment cycles of FTD/TPI plus oxaliplatin, continuing until disease progression, intolerable toxicities, or participant withdrawal from the trial.

Drug: Trifluridine/tipiracil; Drug: Oxaliplatin

Interventions

Trifluridine/tipiracil DRUG

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.

Also known as: FTD/TPI

FTD/TPI plus oxaliplatin

Oxaliplatin DRUG

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

FTD/TPI plus oxaliplatin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ALT (SGPT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases
• Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with bilirubin levels \>1.5 x ULN
• Serum Creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥60 mL/min for participants with creatinine levels \>1.5 x ULN (Cockcroft-Gault method)
• Participants must have recovered adequately from any major surgery, prior to starting therapy.
• Participants must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• 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.
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the individual's participation for the full duration of the trial, or is not in the best interest of the individual to participate, in the opinion of the treating investigator.
• Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the treating investigator.
• Participants with uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations/substance abuse disorders that would limit compliance with study requirements.
• Participants pregnant or breastfeeding expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 5 months after the last dose of trial treatment. Pregnant or breastfeeding women are excluded from this study because it is unknown if the combination of FTD/TPI and oxaliplatin create the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug combination, breastfeeding should be discontinued if the mother is enrolled on this trial.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Comprehensive Cancer Network: collaborator

Study Sites (2)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Related Publications (2)

• Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.

  PMID: 38230766 BACKGROUND

• Nghiem V, Wood S, Ramachandran R, Williams G, Outlaw D, Paluri R, Kim YI, Gbolahan O. Short- and Long-Term Survival of Metastatic Biliary Tract Cancer in the United States From 2000 to 2018. Cancer Control. 2023 Jan-Dec;30:10732748231211764. doi: 10.1177/10732748231211764.

  PMID: 37926828 BACKGROUND

MeSH Terms

Conditions

Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms

Interventions

trifluridine tipiracil drug combination; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Madison Conces, MD

  Case Comprehensive Cancer Center, University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madison Conces, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 28, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 year after completion of the study
• Access Criteria: Access available after completion of the study

Locations

US (2)