Trifluridine/Tipiracil + Oxaliplatin for Biliary Tract Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of drugs, trifluridine/tipiracil (a chemotherapy medication) and oxaliplatin (a platinum-based chemotherapy drug), to determine if they outperform the current treatment for advanced biliary tract cancer (BTC) that has stopped responding to previous treatments. The goal is to identify a more effective second-line therapy for individuals whose BTC hasn't improved with initial treatment. It suits those diagnosed with advanced BTC, including cholangiocarcinoma and gallbladder carcinoma, who have already tried one unsuccessful treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are on certain investigational drugs or high-dose steroids. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that the combination of trifluridine/tipiracil (FTD/TPI) and oxaliplatin is generally well-tolerated by patients. Studies have demonstrated that this combination has a predictable and manageable safety profile. While some side effects are expected, they are mostly manageable for those receiving the treatment. Another study in patients with similar conditions found that FTD/TPI alone exhibited promising antitumor activity, suggesting effectiveness without severe issues. Oxaliplatin, a common chemotherapy drug, has a well-known safety profile. Overall, previous research indicates that the treatment is well-tolerated.12345
Why are researchers excited about this study treatment for biliary tract cancer?
Unlike the standard treatments for biliary tract cancer, which often involve chemotherapy drugs like gemcitabine and cisplatin, the combination of Trifluridine/Tipiracil with Oxaliplatin offers a fresh approach. Trifluridine/Tipiracil is designed to interfere with cancer cell division by incorporating itself into DNA, which is a different mechanism compared to the usual treatments. Additionally, using Oxaliplatin, a platinum-based drug, potentially enhances the effectiveness by further damaging cancer cell DNA. Researchers are excited about this combination because it might offer improved effectiveness and tolerability, giving patients a new hope for better outcomes.
What evidence suggests that this treatment might be an effective treatment for biliary tract cancer?
Research has shown that the combination of trifluridine/tipiracil (FTD/TPI) and oxaliplatin holds promise for treating advanced biliary tract cancer (BTC). Studies have found that FTD/TPI can improve outcomes for patients who have already received extensive treatment for BTC. Evidence suggests that this drug combination may extend patients' lives by several months on average compared to standard treatments. In this trial, participants will receive FTD/TPI plus oxaliplatin, as researchers are studying its strong potential to shrink or control tumor growth. These early findings offer hope that FTD/TPI plus oxaliplatin could serve as a more effective second-line treatment for advanced BTC.34567
Who Is on the Research Team?
Madison Conces, MD
Principal Investigator
Case Comprehensive Cancer Center, University Hospitals
Are You a Good Fit for This Trial?
This trial is for individuals who have advanced biliary tract cancer and whose previous treatments were unsuccessful or stopped working. Participants must have already received treatment, but are now looking for a second-line therapy option.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 14-day treatment cycles of FTD/TPI plus oxaliplatin until disease progression, intolerable toxicities, or withdrawal
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Oxaliplatin
- Trifluridine/Tipiracil
Trial Overview
The study is testing the effectiveness of combining trifluridine/tipiracil (FTD/TPI), an oral medication, with oxaliplatin, which is administered intravenously. This combination will be compared to the standard FOLFOX chemotherapy as a second-line treatment for advanced biliary tract cancer.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will complete 14-day treatment cycles of FTD/TPI plus oxaliplatin, continuing until disease progression, intolerable toxicities, or participant withdrawal from the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Comprehensive Cancer Center
Lead Sponsor
National Comprehensive Cancer Network
Collaborator
Citations
Phase II Trial of Trifluridine/Tipiracil in Patients with ...
Trifluridine/tipiracil (FTD/TPI) shows promising antitumor activity in heavily pretreated patients with advanced biliary tract carcinoma, including patients ...
Efficacy and Safety of Trifluridine/Tipiracil-Containing ...
Median overall survival ranged 8.6-14.4 months and median progression-free survival 3.7-6.8 months with FTD/TPI plus bevacizumab in refractory ...
Innovations in colorectal cancer treatment: trifluridine and ...
The study indicates that FTD/TPI treatment significantly improved median overall survival (OS) compared to the placebo group (7.1 months versus ...
Study protocol of an open-label, single arm phase II trial ...
The aim of TRITICC is to evaluate the safety and efficacy of FTD/TPI plus irinotecan in patients with biliary tract cancer refractory to previous Gemcitabine ...
Trifluridine/tipiracil + oxaliplatin ± nivolumab vs FOLFOX ± ...
Two phase I studies of FTD/TPI in combination with oxaliplatin were conducted (NCT02848443, NCT02848079) and preliminary efficacy results were promising [17].
NCT07146646 | Trifluridine/Tipiracil + Oxaliplatin in ...
This study is evaluating the combination of a medicine called trifluridine/tipiracil (FTD/TPI) and a medicine called oxaliplatin in treating advanced BTCs.
Efficacy and Safety of Trifluridine/Tipiracil-Containing ...
Median overall survival ranged 8.6-14.4 months and median progression-free survival 3.7-6.8 months with FTD/TPI plus bevacizumab in refractory ...
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