Trifluridine/Tipiracil + Oxaliplatin for Biliary Tract Cancer

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.

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.

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

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.

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