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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT07146646
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Biliary Tract Cancer
  • Biliary Tract Neoplasms
  • Cholangiocarcinoma
  • Gallbladder Cancer
  • Gallbladder Carcinoma

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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).

Key Dates

Start date
Dec 1, 2025
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Disease control rate (DCR) by RECIST v1.1 [ Time Frame: Every 8 weeks until treatment discontinuation, up to 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44195
Bassam Estfan, MD
[email protected]
216-445-9449
Bassam Estfan, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106
Madison Conces, MD
[email protected]
216-844-3951
Madison Conces, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By research site
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center· Cleveland, OHUniversity Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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