[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07146646":3,"trial-entities:NCT07146646":161,"trial-summary:NCT07146646":165},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":45,"secondary_outcomes":50,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":115,"locations":118,"central_contacts":147,"overall_officials":149,"references":152,"see_also_links":160},"NCT07146646","CASE2225","Trifluridine\u002FTipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer","A Phase II Trial of Trifluridine\u002FTipiracil Plus Oxaliplatin in Patients With Advanced or Metastatic Biliary Tract Cancer Following First-Line Therapy","RECRUITING","2027-04","2026-02","2026-02-19","2025-12-01","Case Comprehensive Cancer Center","OTHER",true,"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\u002Ftipiracil (FTD\u002FTPI) and another drug called oxaliplatin works better than FOLFOX for advanced BTC as second-line therapy. FTD\u002FTPI are pills that are taken by mouth, whereas oxaliplatin is given intravenously (by IV).","BTCs are difficult to treat. It is estimated that in the United States (US) approximately 15,000-20,000 people will be diagnosed with a BTC per year. In 2024, liver and intrahepatic bile duct cancers were the 5th leading cause of death from cancer among men and 7th among women in the US (1). Most people with BTCs have cancer that has spread or cannot be removed with surgery, so systemic treatments are the only option. However, the median survival after being diagnosed with an advanced BTC is still only 4.5 months, so it is important that we find better treatment options (2).\n\nThis study is evaluating the combination of a medicine called trifluridine\u002Ftipiracil (FTD\u002FTPI) and a medicine called oxaliplatin in treating advanced BTCs. While FTD\u002FTPI has been used to treat other types of cancer, it is not yet approved to treat BTCs, so it is experimental. On the other hand, oxaliplatin is a medicine that has been previously used to treat BTCs.",[19,20,21,22,23],"Biliary Tract Cancer","Biliary Tract Neoplasms","Cholangiocarcinoma","Gallbladder Cancer","Gallbladder Carcinoma",[25,26,27],"Trifluridine\u002Ftipiracil","FTD\u002FTPI","Oxaliplatin","INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},27,"ESTIMATED",[36,42],{"type":37,"name":25,"description":38,"armGroupLabels":39,"otherNames":41},"DRUG","FTD\u002FTPI will be taken by mouth on Days 1-5 of the 14-day treatment cycle. The starting does is 25mg\u002Fm2 twice per day.",[40],"FTD\u002FTPI plus oxaliplatin",[26],{"type":37,"name":27,"description":43,"armGroupLabels":44},"Oxaliplatin is given on Day 1 of each 14-day cycle. It is given intravenously (by IV) over 2 hours.",[40],[46],{"measure":47,"description":48,"timeFrame":49},"Disease control rate (DCR) by RECIST v1.1","DCR is the percentage of participants whose cancer did not get worse after treatment (i.e. the percentage of participants who had CR, PR, or SD, as defined below), and this will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.\n\nPer RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.","Every 8 weeks until treatment discontinuation, up to 6 months",[51,55,57,59,61,62,63,65,66,67,70,74],{"measure":52,"description":53,"timeFrame":54},"Safety and tolerability","Measured by the grade of adverse events (AEs) per CTCAE version 5.0","Day 1",{"measure":52,"description":53,"timeFrame":56},"At treatment discontinuation, up to 6 months",{"measure":52,"description":53,"timeFrame":58},"30 days post-study treatment discontinuation, up to 6 months",{"measure":52,"description":60,"timeFrame":54},"Measured by the incidence of adverse events (AEs)",{"measure":52,"description":60,"timeFrame":56},{"measure":52,"description":60,"timeFrame":58},{"measure":52,"description":64,"timeFrame":54},"Measured by the duration of adverse events (AEs)",{"measure":52,"description":64,"timeFrame":56},{"measure":52,"description":64,"timeFrame":58},{"measure":68,"description":69,"timeFrame":49},"Objective response rate (ORR) by RECIST v1.1","ORR is the percentage of participants whose cancer got better after treatment (i.e. the percentage of participants who had CR or PR, as defined below), and this will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.\n\nPer RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.",{"measure":71,"description":72,"timeFrame":73},"Progression free survival (PFS)","Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.","2 years post-study treatment",{"measure":75,"description":76,"timeFrame":73},"Overall survival (OS)","Overall survival (OS) is defined as the duration of time from start of treatment to time of death from any cause.","ALL","19 Years",null,false,{"inclusion":82,"exclusion":99,"raw_text":114},[83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98],"Participants must have histologically or cytologically confirmed biliary tract cancer (BTC) including cholangiocarcinoma and gallbladder carcinoma. Individuals with ampullary cancers will not be considered eligible. Cancer must be advanced stage or metastatic.","Participants must have received only one line of systemic therapy for advanced or metastatic BTCs.","Note: Individuals who have either progressed or are intolerant to the prior therapy can be included in this study.","Age \\>18 years on day of signing informed consent. Because no dosing or adverse event data are currently available on the use of FTD\u002FTPI in individuals ≤18 years of age, children are excluded from this study.","Performance status: ECOG performance status of 0 or 1.","At least one index lesion is measurable based on RECIST 1.1.","Participants must have organ and marrow function as defined below:","Absolute neutrophil count ≥ 1,500\u002FmcL","Platelet count ≥75,000\u002FmcL","AST (SGOT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases","ALT (SGPT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases","Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with bilirubin levels \\>1.5 x ULN","Serum Creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin for participants with creatinine levels \\>1.5 x ULN (Cockcroft-Gault method)","Participants must have recovered adequately from any major surgery, prior to starting therapy.","Participants must have the ability to understand and the willingness to sign a written informed consent document.","Agree to use adequate method of contraception.",[100,101,102,103,104,105,106,107,108,109,110,111,112,113],"Participants receiving any other investigational agents.","Participant has received investigational therapy within 4 weeks or within 5 half-lives of the therapeutic agent (whichever is shorter).","Received more than one line of systemic therapy for bile duct cancer. Adjuvant therapy will not be counted as line of systemic therapy.","Receiving systemic steroid therapy (\\>10mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.","Prior treatment with FTD\u002FTPI or oxaliplatin.","Known additional malignancy that currently requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has already undergone potentially curative therapy.","Known central nervous system metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable without evidence of new or enlarging brain metastases and are not using steroids for at least 7 days prior to trial treatment.","Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (\\> 10 mg\u002Fday or equivalent of prednisone) or immunosuppressive agents. (thyroid disease and diabetes are allowed)","Interstitial lung disease or active, non-infectious pneumonitis.","Active infection requiring systemic antibiotics.","History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the individual's participation for the full duration of the trial, or is not in the best interest of the individual to participate, in the opinion of the treating investigator.","Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the treating investigator.","Participants with uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations\u002Fsubstance abuse disorders that would limit compliance with study requirements.","Participants pregnant or breastfeeding expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 5 months after the last dose of trial treatment. Pregnant or breastfeeding women are excluded from this study because it is unknown if the combination of FTD\u002FTPI and oxaliplatin create the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug combination, breastfeeding should be discontinued if the mother is enrolled on this trial.","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed biliary tract cancer (BTC) including cholangiocarcinoma and gallbladder carcinoma. Individuals with ampullary cancers will not be considered eligible. Cancer must be advanced stage or metastatic.\n* Participants must have received only one line of systemic therapy for advanced or metastatic BTCs.\n* Note: Individuals who have either progressed or are intolerant to the prior therapy can be included in this study.\n* Age \\>18 years on day of signing informed consent. Because no dosing or adverse event data are currently available on the use of FTD\u002FTPI in individuals ≤18 years of age, children are excluded from this study.\n* Performance status: ECOG performance status of 0 or 1.\n* At least one index lesion is measurable based on RECIST 1.1.\n* Participants must have organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelet count ≥75,000\u002FmcL\n  * AST (SGOT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases\n  * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases\n  * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with bilirubin levels \\>1.5 x ULN\n  * Serum Creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin for participants with creatinine levels \\>1.5 x ULN (Cockcroft-Gault method)\n* Participants must have recovered adequately from any major surgery, prior to starting therapy.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Agree to use adequate method of contraception.\n\nExclusion Criteria:\n\n* Participants receiving any other investigational agents.\n* Participant has received investigational therapy within 4 weeks or within 5 half-lives of the therapeutic agent (whichever is shorter).\n* Received more than one line of systemic therapy for bile duct cancer. Adjuvant therapy will not be counted as line of systemic therapy.\n* Receiving systemic steroid therapy (\\>10mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Prior treatment with FTD\u002FTPI or oxaliplatin.\n* Known additional malignancy that currently requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has already undergone potentially curative therapy.\n* Known central nervous system metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable without evidence of new or enlarging brain metastases and are not using steroids for at least 7 days prior to trial treatment.\n* Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (\\> 10 mg\u002Fday or equivalent of prednisone) or immunosuppressive agents. (thyroid disease and diabetes are allowed)\n* Interstitial lung disease or active, non-infectious pneumonitis.\n* Active infection requiring systemic antibiotics.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the individual's participation for the full duration of the trial, or is not in the best interest of the individual to participate, in the opinion of the treating investigator.\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the treating investigator.\n* Participants with uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations\u002Fsubstance abuse disorders that would limit compliance with study requirements.\n* Participants pregnant or breastfeeding expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 5 months after the last dose of trial treatment. Pregnant or breastfeeding women are excluded from this study because it is unknown if the combination of FTD\u002FTPI and oxaliplatin create the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug combination, breastfeeding should be discontinued if the mother is enrolled on this trial.",[116,117],"ADULT","OLDER_ADULT",[119,136],{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":124,"contacts":125,"geoPoint":133},"University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center","Cleveland","Ohio","44106","United States",[126,131],{"name":127,"role":128,"phone":129,"email":130},"Madison Conces, MD","CONTACT","216-844-3951","Madison.Conces@UHhospitals.org",{"name":127,"role":132},"PRINCIPAL_INVESTIGATOR",{"lat":134,"lon":135},41.4995,-81.69541,{"facility":137,"status":138,"city":121,"state":122,"zip":139,"country":124,"contacts":140,"geoPoint":146},"Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center","NOT_YET_RECRUITING","44195",[141,145],{"name":142,"role":128,"phone":143,"email":144},"Bassam Estfan, MD","216-445-9449","estfanb@ccf.org",{"name":142,"role":132},{"lat":134,"lon":135},[148],{"name":127,"role":128,"phone":129,"email":130},[150],{"name":127,"affiliation":151,"role":132},"Case Comprehensive Cancer Center, University Hospitals",[153,157],{"pmid":154,"type":155,"citation":156},"38230766","BACKGROUND","Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322\u002Fcaac.21820. Epub 2024 Jan 17.",{"pmid":158,"type":155,"citation":159},"37926828","Nghiem V, Wood S, Ramachandran R, Williams G, Outlaw D, Paluri R, Kim YI, Gbolahan O. Short- and Long-Term Survival of Metastatic Biliary Tract Cancer in the United States From 2000 to 2018. Cancer Control. 2023 Jan-Dec;30:10732748231211764. doi: 10.1177\u002F10732748231211764.",[],{"nct_id":4,"conditions":162,"biomarkers":164},[21,23,163],"Malignant neoplasm of biliary tract",[],{"nct_id":4,"found":15,"summary":166,"prompt_version":176},{"design":167,"status":168,"heading":169,"summary":170,"follow_up":171,"word_count":172,"commitments":173,"compensation":174,"drugs_mentioned":175},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 27 participants.","completed","Study of Trifluridine\u002FTipiracil + Oxaliplatin for Advanced Biliary Tract Cancer","This study is for people with advanced or metastatic biliary tract cancer (cancer that has spread) who have already received one treatment that didn't work or stopped working. Researchers are testing a combination of two drugs: trifluridine\u002Ftipiracil (pills taken by mouth) and oxaliplatin (given by IV). Oxaliplatin has been used for biliary tract cancer before, but trifluridine\u002Ftipiracil is new for this type of cancer. The goal is to see if this combination works better than current treatments to control the cancer. They will measure how well the cancer is controlled every 8 weeks for up to 6 months. About 27 people are expected to join this study.","Your disease control will be measured every 8 weeks until treatment stops, for up to 6 months.",107,"You would take trifluridine\u002Ftipiracil pills daily for 5 days, and receive oxaliplatin by IV on day 1, every 14 days. Your disease control will be checked every 8 weeks for up to 6 months.","Not stated in the trial record.",[25,27],"v2"]