AzTrials
AzTrials

Biliary Tract CancerPhase 2NCT07146646

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

A Phase 2 study testing Trifluridine/tipiracil and Oxaliplatin in people with Biliary Tract Cancer and Biliary Tract Neoplasms, run by Case Comprehensive Cancer Center at 2 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Trifluridine/tipiracil and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
2 sitesUnited States
Study dates
1 Dec 2025to Apr 2027
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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.
  • Agree to use adequate method of contraception.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Trifluridine/tipiracil, Oxaliplatin
Keywords
Trifluridine/tipiracil, FTD/TPI, Oxaliplatin
Medical subject headings
Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trifluridine/tipiracilDrug

    Also called FTD/TPI

    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.

  • OxaliplatinDrug

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

Study groups in NCT07146646
Study groupRoleWhat they receive
FTD/TPI plus oxaliplatinExperimentalParticipants will complete 14-day treatment cycles of FTD/TPI plus oxaliplatin, continuing until disease progression, intolerable toxicities, or participant withdrawal from the trial.
Receives: Drug: Trifluridine/tipiracil; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Every 8 weeks until treatment discontinuation, up to 6 months

Secondary outcomes (12)

  1. Safety and tolerability

    Measured by the grade of adverse events (AEs) per CTCAE version 5.0

    Measured: Day 1

  2. Safety and tolerability

    Measured by the grade of adverse events (AEs) per CTCAE version 5.0

    Measured: At treatment discontinuation, up to 6 months

  3. Safety and tolerability

    Measured by the grade of adverse events (AEs) per CTCAE version 5.0

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

  4. Safety and tolerability

    Measured by the incidence of adverse events (AEs)

    Measured: Day 1

  5. Safety and tolerability

    Measured by the incidence of adverse events (AEs)

    Measured: At treatment discontinuation, up to 6 months

  6. Safety and tolerability

    Measured by the incidence of adverse events (AEs)

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

  7. Safety and tolerability

    Measured by the duration of adverse events (AEs)

    Measured: Day 1

  8. Safety and tolerability

    Measured by the duration of adverse events (AEs)

    Measured: At treatment discontinuation, up to 6 months

  9. Safety and tolerability

    Measured by the duration of adverse events (AEs)

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

  10. Objective response rate (ORR) by RECIST v1.1

    ORR is the percentage of participants whose cancer got better after treatment (i.e. the percentage of participants who had CR or PR, 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.

    Measured: Every 8 weeks until treatment discontinuation, up to 6 months

  11. Progression free survival (PFS)

    Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

    Measured: 2 years post-study treatment

  12. Overall survival (OS)

    Overall survival (OS) is defined as the duration of time from start of treatment to time of death from any cause.

    Measured: 2 years post-study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2025
  2. Study start1 Dec 2025
  3. Primary completionFeb 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Why it stopped: Interim Analysis

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07146646
Sponsor's protocol ID
CASE2225
Status last verified
Oct 2026
First submitted
12 Aug 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 38230766

  • 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.

    PubMed 37926828

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trifluridine/tipiracil and Oxaliplatin in people with Biliary Tract Cancer and Biliary Tract Neoplasms, run by Case Comprehensive Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (DCR) by RECIST v1.1 (time frame: Every 8 weeks until treatment discontinuation, up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07146646, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in