Cancer statistics, 2024.
Rebecca L Siegel, Angela N Giaquinto, Ahmedin Jemal
https://pubmed.ncbi.nlm.nih.gov/38230766Actively Recruiting
Phase 2
Age: 19Years +
All Genders
ID07146646
A Phase II Study of Trifluridine/Tipiracil Plus Oxaliplatin in Advanced or Metastatic Biliary Tract Cancer After First-Line Therapy
Led by Case Comprehensive Cancer Center · Updated on 2026-02-19
27
Participants Needed
2
Research Sites
8 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
Researchers are evaluating a new combination treatment for people with advanced or metastatic biliary tract cancer (BTC) who have already received one prior systemic therapy that did not improve their cancer or has stopped working. This trial compares the use of trifluridine/tipiracil (FTD/TPI) combined with oxaliplatin against the standard chemotherapy called FOLFOX. BTC is a challenging cancer to treat with a poor survival rate, so finding better treatment options is crucial. This is a phase II study focusing on the effectiveness and safety of this new drug combination. Participants in the study will receive 14-day treatment cycles of FTD/TPI and oxaliplatin. The FTD/TPI pills are taken orally on days 1 through 5 of each cycle at a dose of 25 mg/m2 twice daily, and oxaliplatin is given intravenously on day 1 over two hours. Treatment will continue until the cancer worsens, side effects become intolerable, or participants choose to stop. This combination is experimental for BTC, while oxaliplatin has been used previously for this cancer. During the trial, researchers will regularly assess disease control using scans every 8 weeks for up to 6 months. Safety and tolerability will be monitored at multiple points during and after treatment, including 30 days post-treatment. Participants will also be followed for progression-free and overall survival for up to two years after treatment ends. The total participation time may vary depending on individual progress and treatment response.
CONDITIONS
Brief Title
Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participants must have histologically or cytologically confirmed advanced or metastatic biliary tract cancer, including cholangiocarcinoma and gallbladder carcinoma, but not ampullary cancers.
- Participants must have received only one line of systemic therapy for advanced or metastatic BTC.
- Participants may have progressed on or be intolerant to prior therapy.
- Age greater than 18 years at informed consent.
- ECOG performance status of 0 or 1.
- At least one measurable lesion based on RECIST 1.1.
- Adequate organ and marrow function with specified blood count and liver/kidney test limits.
- Recovery from any major surgery before starting therapy.
- Ability and willingness to sign informed consent.
- Agreement to use effective contraception.
You will not qualify if you...
- Receiving any other investigational agents.
- Received investigational therapy within 4 weeks or 5 half-lives prior to enrollment.
- Received more than one line of systemic therapy for bile duct cancer (excluding adjuvant therapy).
- Receiving systemic steroids over 10 mg prednisone or equivalent within 7 days before trial treatment.
- Prior treatment with trifluridine/tipiracil or oxaliplatin.
- Active additional malignancy requiring treatment, except certain skin or cervical cancers.
- Known central nervous system metastases or carcinomatous meningitis unless stable and steroid-free.
- Active autoimmune disease requiring systemic treatment or severe autoimmune history.
- Interstitial lung disease or active non-infectious pneumonitis.
- Active infections requiring systemic antibiotics.
- Any condition or abnormality that may interfere with study participation or outcomes.
- Psychiatric or substance abuse disorders limiting compliance.
- Uncontrolled illness, including heart failure, unstable angina, or cardiac arrhythmia.
- Pregnant or breastfeeding women or those expecting to conceive/father children during the trial and up to 5 months after last dose.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 14-day cycles until disease progression or discontinuation
Participants receive a combination of trifluridine/tipiracil taken by mouth on Days 1-5 and oxaliplatin given intravenously on Day 1 of each 14-day cycle. Treatment continues until disease progression, intolerable side effects, or participant withdrawal.
Every 2 weeks for treatment administration and safety assessments
Follow-up
Duration - Up to 2 years post-treatment
Participants are monitored for safety, progression-free survival, and overall survival after treatment ends.
Periodic visits up to 2 years after treatment discontinuation
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
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Research Team
M
Madison Conces, MD
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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Published Research Related To This Trial
Short- and Long-Term Survival of Metastatic Biliary Tract Cancer in the United States From 2000 to 2018.
Van Nghiem, Sarah Wood, Rekha Ramachandran...
https://pubmed.ncbi.nlm.nih.gov/37926828