[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416347":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":38,"studyPopulation":30,"armGroups":39,"interventions":52,"overallOfficials":72,"centralContacts":77,"locations":86,"responsibleParty":130,"collaborators":132,"id":135,"slug":30,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":30,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":30,"enrollmentInfo":143,"targetDuration":30,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":89,"whyStopped":30,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Teclison Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"Overall Survival for the mCRC cohort","From the first day of treatment to death","24 months",{"measure":14,"description":15,"timeFrame":16},"Overall Response Rate (ORR) for the NSCLC cohort","Per RECIST 1.1 criteria","within 24 months",[18,21,24,27],{"measure":19,"description":20,"timeFrame":12},"Duration of Response","per RECIST 1.1",{"measure":22,"description":23,"timeFrame":12},"Response rate","in TATE treated or TATE-untreated lesions by RECIST and mRECIST",{"measure":25,"description":26,"timeFrame":12},"PFS","Progression Free Survival",{"measure":28,"description":29,"timeFrame":12},"TTP","Time to Progression",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","Open-label study in two indications. The mCRC cohort will be a randomized trial for TATE+Pembrolizumab versus standard 3rd line therapy for mCRC. The NSCLC cohort will be single-arm study.","TREATMENT",{"masking":37,"maskingDescription":30,"whoMasked":30},"NONE","This study is an open-label study to treat patients with refractory metastatic colorectal cancer and non-small cell lung cancer with liver metastasis. Patients enrolled in the mCRC cohort will be randomized to receive study treatment Trans-arterial Tirapazamine Embolization (TATE)+Pembrolizumab or FDA-approved standard of care, such as TAS-102 or regorafenib, and their Overall Survival (OS) will be compared in the two cohorts as the primary endpoint. Patients enrolled in the NSCLC cohort will all receive study treatment TATE+Pembrolizaumb and Overall Response Rate (ORR) will be the primary endpoint.",[40,48],{"label":41,"type":42,"description":43,"interventionNames":44},"colorectal cancer","EXPERIMENTAL","metastatic colorectal cancer progressed on at least two lines of chemotherapy",[45,46,47],"Drug: TATE and pembrolizumab","Drug: TAS-102 pill","Drug: Regorafenib Pill",{"label":49,"type":42,"description":50,"interventionNames":51},"NSCLC","Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy",[45],[53,60,66],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"DRUG","TATE and pembrolizumab","All liver metastatic lesions will be treated with TATE for maximally debulking. Pembrolizumab IV infusion per standard schedule every 3 or 6 weeks until progression or maximally 2 years.",[49,41],[59],"TATE: Trans-arterial Tirapazamine Embolization;",{"type":54,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"TAS-102 pill","The comparator of the mCRC arm is TAS-102 at 60 mg BID 5 days per week for 2 weeks then 2 weeks off.",[41],[65],"LONSURF",{"type":54,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Regorafenib Pill","As an alternative to TAS-102 per treating physician's discretion. If selected, Regorafenib 160 mg oral daily for 3 weeks on and one week off, every 4 weeks per cycle. Do not take Regoarefnib if taking TAS-102.",[41],[71],"STIVARGA",[73],{"name":74,"affiliation":75,"role":76},"Ray Lee","Teclison Limited","STUDY_DIRECTOR",[78,83],{"name":79,"role":80,"phone":81,"phoneExt":30,"email":82},"Ray Lee, MD. PhD.","CONTACT","8043341076","ray.lee01@teclison.com",{"name":84,"role":80,"phone":30,"phoneExt":30,"email":85},"Chiwei Lu","chiwei.lu4@teclison.com",[87,105,119],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"University of California, Irvine Medical Center","RECRUITING","Orange","California","92868","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-117.85311,33.78779,{"lat":99,"lon":98},[102],{"name":103,"role":80,"phone":30,"phoneExt":30,"email":104},"Miranda Duron","mnduron@hs.uci.edu",{"facility":106,"status":89,"city":107,"state":30,"zip":30,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"China Medical University Hsinchu Hospital","Hsinchu","Taiwan","TW",{"type":96,"coordinates":111},[112,113],120.96861,24.80361,{"lat":113,"lon":112},[116],{"name":117,"role":80,"phone":30,"phoneExt":30,"email":118},"sandy Lai","sandy6618@teclison.com",{"facility":120,"status":89,"city":121,"state":30,"zip":30,"country":108,"countryCode":109,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Chung Shan Medical University Hospital","Taichung",{"type":96,"coordinates":123},[124,125],120.6839,24.1469,{"lat":125,"lon":124},[128],{"name":129,"role":80,"phone":30,"phoneExt":30,"email":118},"Sandy Lai",{"type":131,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[133],{"name":134,"class":6},"Merck Sharp & Dohme LLC","100416347",false,"NCT04701476","TATE and Pembrolizumab (MK3475) in mCRC and NSCLC","An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung Cancer With a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and Pembrolizumab","Inclusion Criteria:\n\n* Liver metastatic MSS-mCRC or NSCLC without EGFR or AKT mutations\n* mCRC progressed on at least two lines of standard chemotherapy; or\n* NSCLC progressed on chemotherapy and an immune checkpoint inhibitor\n* Measurable disease\n* ECOG 0-1\n* At least 4 weeks from prior chemotherapy and free from chemo-related toxicity\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior organ transplantation\n* Liver metastasis more than 50%\n* Oxygen saturation less than 92% in room air\n* Prior autoimmune disorder\n* CNS metastasis\n* Major GI bleeding in the last 2 months","ALL","18 Years",{"count":144,"type":145},110,"ESTIMATED","INTERVENTIONAL",[148],"PHASE2","Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab.",[151],"Colorectal Cancer; Lung Cancer",[41,49,153,154,155],"pembrolizumab","tirapazamine","Liver metastasis","2026-04-15",{"date":158,"type":159},"2026-04-16","ACTUAL",{"date":161,"type":159},"2021-05-20",{"date":163,"type":145},"2027-09-30",{"name":5,"class":6},3]