Actively Recruiting
Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer
Led by Case Comprehensive Cancer Center · Updated on 2026-02-19
27
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
Sponsors
C
Case Comprehensive Cancer Center
Lead Sponsor
N
National Comprehensive Cancer Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically or cytologically confirmed advanced or metastatic biliary tract cancer, including cholangiocarcinoma and gallbladder carcinoma
- Have received only one line of systemic therapy for advanced or metastatic BTC
- Participants who progressed on or are intolerant to prior therapy are eligible
- Be 19 years or older at the time of informed consent
- Have an ECOG performance status of 0 or 1
- Have at least one measurable lesion based on RECIST 1.1
- Have adequate organ and marrow function as defined by specific blood counts and liver and kidney function tests
- Have recovered adequately from any major surgery before starting therapy
- Be able to understand and willing to sign the informed consent
- Agree to use effective contraception methods
You will not qualify if you...
- Receiving any other investigational agents
- Received investigational therapy within 4 weeks or 5 half-lives before trial treatment
- Received more than one line of systemic therapy for bile duct cancer (adjuvant therapy excluded)
- Receiving systemic steroids (>10 mg prednisone or equivalent) or immunosuppressive therapy within 7 days before treatment
- Prior treatment with trifluridine/tipiracil (FTD/TPI) or oxaliplatin
- Have active additional cancers requiring treatment, except certain skin cancers and treated cervical cancer
- Have known central nervous system metastases or carcinomatous meningitis unless stable and off steroids for 7 days
- Have active autoimmune disease needing systemic treatment within past 3 months or severe autoimmune disease
- Have interstitial lung disease or active non-infectious pneumonitis
- Have active infection requiring systemic antibiotics
- Have conditions or abnormalities that could interfere with trial participation or results
- Have psychiatric or substance abuse disorders interfering with study compliance
- Have uncontrolled illnesses like heart failure, unstable angina, or serious psychiatric/social issues
- Are pregnant, breastfeeding, or planning to conceive or father children during the trial and 5 months after last treatment dose
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
2
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
Research Team
M
Madison Conces, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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