[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02174549":3,"trial-entities:NCT02174549":116,"trial-summary:NCT02174549":121},{"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":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":31,"interventions":34,"primary_outcomes":46,"secondary_outcomes":51,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":98,"overall_officials":102,"references":107,"see_also_links":112},"NCT02174549","LT001","Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer","Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer","RECRUITING","2028-09-30","2026-04","2026-04-20","2014-09","Teclison Ltd.","INDUSTRY",true,"This phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating agent, tirapazamine, when it is combined with embolization in liver cancer. Liver cancer patients who are Child-Pugh score A, suitable for embolization with tumor no more than 4 nodules are eligible. Tirapazamine will be given by intra-arterial injection before embolization. Treatment effect is evaluated by MRI based on mRECIST criteria. Repeat treatment is necessary only if disease progression. Dose escalation cohort has been completed. Expansion cohort is open for metastatic liver dominant neuroendocrine tumor.","The study is a 3+3 design for dose escalation. Each cohort will have 3-6 patients based on tolerability. Patients will receive escalated doses of tirapazamine until maximally tolerated dose. Embolization is performed per standard practice using Lipiodol and Gelfoam under X-ray guidance. Once a suitable dose is determined, an expansion cohort of 15 patients will be treated with the recommended phase 2 dose to determine preliminary efficacy. Expansion cohorts include (1) hepatocellular carcinoma, (2) metastatic solid tumors with liver metastasis, and (3) neuroendocrine tumor. Adverse events are evaluated by CTCAE vs. 5.0 and efficacy is evaluated by MRI using modified RECIST criteria and RECIST criteria.\n\nThe dose escalation part has been completed. Only the third cohort or neuroendocrine tumor remains active for future patient enrollment.",[19,20,21],"Hepatocellular Carcinoma","Gastrointestinal Cancer Metastatic","Neuroendocrine Tumors",[23,24,25],"Hypoxia","Embolization","Tirapazamine","INTERVENTIONAL","TREATMENT",[29,30],"PHASE1","PHASE2",{"count":32,"type":33},25,"ESTIMATED",[35,39],{"type":36,"name":25,"description":37,"armGroupLabels":38},"DRUG","Intra-arterial injection into the tumor feeding artery",[25],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"PROCEDURE","Conventional Transarterial Embolization (TAE)","Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia",[25],[45],"TAE conducted with Lipiodol and Surgifoam as the embolizing agents.",[47],{"measure":48,"description":49,"timeFrame":50},"Overall Response rate (ORR) by RECIST","Overall Response Rate by RECIST criteria","2 years",[52,55],{"measure":53,"description":54,"timeFrame":50},"Overall Response Rate","Overall Response Rate by mRECIST criteria",{"measure":56,"description":57,"timeFrame":50},"Duration of Response","Duration of Response by RECIST and mRECIST","ALL","20 Years","99 Years",false,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"Inclusion Criteria:\n\n1. Patients with well-differentiated NET and liver-dominant metastatic disease with intrahepatic disease progression, regardless of primary tumor origin or tumor functional status. Patients may have extrahepatic lesions as long as the majority of the disease burden is intrahepatic.\n2. No limitation in hepatic lesion tumor size or number but the total volume of liver tumors cannot exceed 50% of the liver volume.\n3. Patients are allowed to have prior US Food and Drug Administration (FDA)-approved treatments, including systemic therapies, surgery, ablation, or transarterial therapies for the metastatic NET.\n4. Age 20 or higher, ECOG functional status 0-1, and with no known major cardiac, pulmonary, or renal dysfunction.\n5. Are candidates for TAE or TACE and without portal vein occlusion per treating interventional radiologists.\n6. ANC no less than 1000 \u002FμL. Hemoglobin ≥ 9 gm\u002FdL. Platelets no less than 50,000 \u002FμL. Creatinine no more than 2.0 mg\u002FdL. AST, ALT no more than 5X upper limit of normal. Bilirubin no more than 2.5 mg\u002Fdl. PT prolongation ≤ 4 sec above upper limit of normal.\n7. Woman of child-bearing potential (WOCBP) should use highly effective contraception during trial participation and for 6 months after the last dose of tirapazamine and men who are partners with WOCBP should use highly effective contraception, including barrier contraception, during trial participation and for 3 months after the last dose of tirapazamine.",[67,68],"ADULT","OLDER_ADULT",[70,85],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":82},"Stanford University","Palo Alto","California","94305","United States",[77],{"name":78,"role":79,"phone":80,"email":81},"Mikayla Easterling","CONTACT","650-724-3698","maeast@stanford.edu",{"lat":83,"lon":84},37.44188,-122.14302,{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":75,"contacts":90,"geoPoint":95},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",[91],{"name":92,"role":79,"phone":93,"email":94},"Veronica Faris","215-573-9765","veronica.faris@pennmedicine.upenn.edu",{"lat":96,"lon":97},39.95238,-75.16362,[99],{"name":100,"role":79,"email":101},"Ray Lee","info@teclison.com",[103],{"name":104,"affiliation":105,"role":106},"Michael Soulen, MD","Univ. of Pennsylvania","PRINCIPAL_INVESTIGATOR",[108],{"pmid":109,"type":110,"citation":111},"34041204","BACKGROUND","Abi-Jaoudeh N, Dayyani F, Chen PJ, Fernando D, Fidelman N, Javan H, Liang PC, Hwang JI, Imagawa DK. Phase I Trial on Arterial Embolization with Hypoxia Activated Tirapazamine for Unresectable Hepatocellular Carcinoma. J Hepatocell Carcinoma. 2021 May 17;8:421-434. doi: 10.2147\u002FJHC.S304275. eCollection 2021.",[113],{"label":114,"url":115},"Phase 1 dose escalation result in Hepatocellular carcinoma","https:\u002F\u002Fpubmed.ncbi.nlm.nih.gov\u002F34041204\u002F",{"nct_id":4,"conditions":117,"biomarkers":120},[19,118,119],"Malignant Digestive System Neoplasm","Neuroendocrine Neoplasm",[],{"nct_id":4,"found":15,"summary":122,"prompt_version":132},{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is a Phase 1 study with a 3+3 dose escalation design, meaning a small group of 3-6 patients receives increasing doses until the best dose is found. An expansion group of 15 patients will then receive this dose to check for early effectiveness.","completed","Dose-Defining Study of Tirapazamine and Embolization for Liver Cancer","This study is testing the best dose and safety of a drug called tirapazamine when combined with conventional transarterial embolization (TAE) for certain liver cancers. Tirapazamine is given by injection directly into the liver tumor's blood supply before TAE, which uses Lipiodol and Gelfoam to block blood flow to the tumor. This combination aims to create a low-oxygen environment in the tumor, which tirapazamine is designed to target. You might be able to join if you have well-differentiated neuroendocrine tumors (NET) that have spread to the liver, or other liver cancers suitable for embolization, with no more than four tumors. The main goal is to see how many patients respond to the treatment, measured by MRI scans over two years. The study is currently enrolling patients with neuroendocrine tumors.","Your response to treatment will be measured by RECIST criteria for up to 2 years.",129,"You would receive tirapazamine by intra-arterial injection, followed by embolization. Treatment effect is evaluated by MRI, and repeat treatment is only given if the disease progresses.","Not stated in the trial record.",[25,41],"v2"]