[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620698":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":140,"collaborators":142,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":26,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":26,"enrollmentInfo":154,"targetDuration":26,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Jiangsu Simcere Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Suvemcitug+ trifluridine\u002Ftipiracil tablets","EXPERIMENTAL","Participants will receive Suvemcitug injection (at 1.5mg\u002Fkg for Phase Ib; and a recommended dose level based on Phase Ib result will be used for Phase III part) on Day 1 and Day 15 of each cycle (28 days), and trifluridine\u002Ftipiracil tablets at 35 mg\u002Fm² on day 1-5, 8-12 of each cycle (28 days), until disease progression, intolerable adverse event, participant withdrawal, or meet other discontinuation criteria as described by the protocol.",[13],"Drug: Suvemcitug injection, trifluridine\u002Ftipiracil tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo+ trifluridine\u002Ftipiracil tablets","PLACEBO_COMPARATOR","Participants will receive Suvemcitug placebo injection on Day 1 and Day 15 of each cycle (28 days), and trifluridine\u002Ftipiracil tablets at 35 mg\u002Fm² on day 1-5, 8-12 of each cycle (28 days), until disease progression, intolerable adverse event, participant withdrawal, or meet other discontinuation criteria as described by the protocol.",[19],"Drug: Suvemcitug placebo injection, trifluridine\u002Ftipiracil tablets",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Suvemcitug injection, trifluridine\u002Ftipiracil tablets","Suvemcitug injection at 1.5mg\u002Fkg, Trifluridine\u002Ftipiracil tablets at 35 mg\u002Fm²",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Suvemcitug placebo injection, trifluridine\u002Ftipiracil tablets","Suvemcitug placebo injection, Trifluridine\u002Ftipiracil tablets at 35 mg\u002Fm².",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Xueyan Li","CONTACT","+86-25-85566666","lixueyan1@zaiming.com",[38,59,74,90,107,122],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Fujian Cancer Hospital","RECRUITING","Fuzhou","Fujian","350014","China","CN",{"type":47,"coordinates":48},"Point",[49,50],119.30611,26.06139,{"lat":50,"lon":49},[53,57],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":56},"Rongbo Lin","+86-591-83660063","linrongbo@fjzlhospital.com",{"name":54,"role":58,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":60,"status":40,"city":61,"state":62,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Harbin Medical University University Cancer Hospital","Harbin","Heilongjiang",{"type":47,"coordinates":64},[65,66],126.65,45.75,{"lat":66,"lon":65},[69,73],{"name":70,"role":34,"phone":71,"phoneExt":26,"email":72},"Yanqiao Zhang","+86-451-86298000","yanqiaozhang@126.com",{"name":70,"role":58,"phone":26,"phoneExt":26,"email":26},{"facility":75,"status":40,"city":76,"state":77,"zip":78,"country":44,"countryCode":45,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"The First Affiliated Hospital of Nanjing Medical University","Nanjing","Jiangsu","210029",{"type":47,"coordinates":80},[81,82],118.77778,32.06167,{"lat":82,"lon":81},[85,89],{"name":86,"role":34,"phone":87,"phoneExt":26,"email":88},"Yanhong Gu","+86-25-83714511","guluer@163.com",{"name":86,"role":58,"phone":26,"phoneExt":26,"email":26},{"facility":91,"status":40,"city":92,"state":93,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Cancer Hospital of Shandong First Medical University","Jinan","Shandong",{"type":47,"coordinates":95},[96,97],116.99722,36.66833,{"lat":97,"lon":96},[100,104,105],{"name":101,"role":34,"phone":102,"phoneExt":26,"email":103},"Shuqin Ni","0086-0531-87984777","nsq163@163.com",{"name":101,"role":58,"phone":26,"phoneExt":26,"email":26},{"name":106,"role":58,"phone":26,"phoneExt":26,"email":26},"Zuoxing Niu",{"facility":108,"status":40,"city":109,"state":110,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Tianjin Medical University Cancer Institute and Hospital","Tianjin","Tianjin Municipality",{"type":47,"coordinates":112},[113,114],117.17667,39.14222,{"lat":114,"lon":113},[117,121],{"name":118,"role":34,"phone":119,"phoneExt":26,"email":120},"Ting Deng","86-22-23359337","xymcdengting@126.com",{"name":118,"role":58,"phone":26,"phoneExt":26,"email":26},{"facility":123,"status":40,"city":124,"state":125,"zip":126,"country":44,"countryCode":45,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"The Second Affiliated Hospital Zhejiang University School of Medicine","Hangzhou","Zhejiang","310009",{"type":47,"coordinates":128},[129,130],120.16142,30.29365,{"lat":130,"lon":129},[133,137,138],{"name":134,"role":34,"phone":135,"phoneExt":26,"email":136},"Kefeng Ding","+86-571-87783777","dingkefeng@zju.edu.cn",{"name":134,"role":58,"phone":26,"phoneExt":26,"email":26},{"name":139,"role":58,"phone":26,"phoneExt":26,"email":26},"Ying Yuan",{"type":141,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[143],{"name":144,"class":6},"Jiangsu Simcere Biologics Co., Ltd","100620698","phase-3-a-phase-ibiii-study-of-suvemcitug-plus-ftdtpi-in-participants-with-refractory-metastatic-colorectal-cancer-100620698",false,"NCT07361003","A Phase Ib\u002FIII Study of Suvemcitug Plus FTD\u002FTPI in Participants With Refractory Metastatic Colorectal Cancer","A Phase Ib\u002FIII Study of Suvemcitug Plus Trifluridine\u002FTipiracil Tablets (FTD\u002FTPI) Versus Placebo Plus Trifluridine\u002FTipiracil Tablets in Participants With Refractory Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* 1\\. Confirmed by histological and\u002For cytological examination as unresectable metastatic colon or rectal adenocarcinoma;\n* 2\\. At least one measurable tumor lesion (RECIST v1.1);\n* 3\\. Previously received fluorouracil, oxaliplatin, and irinotecan based chemotherapy; had previously undergone or was unsuitable for anti-VEGF therapy. (For participants with RAS wild-type, had previously undergone or was unsuitable for anti-EGFR therapy.);\n* 4\\. Refractory metastatic colorectal cancer having progressed on or are intolerant to the last systemic treatment;\n* 5\\. Good organ and bone marrow function (no administration of hematopoietic growth factors, blood transfusion, or platelets within 14 days before screening hematology test);\n* 6\\. RAS mutation status confirmed by testing tumor tissue and \u002For blood sample.\n\nExclusion Criteria:\n\n* 1\\. Having a second active primary malignancy within the past 5 years;\n* 2\\. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring local CNS-directed therapy (e.g., radiotherapy or surgery) or corticosteroid treatment within 2 weeks prior to the first administration of the study treatment;\n* 3\\. Any active infection requiring systemic treatment within 2 weeks prior to the initiation of the study treatment;\n* 4\\. Pleural effusion, pericardial effusion, or ascites that is uncontrolled or has required drainage or medical intervention within 4 weeks prior to the first administration of the study treatment;\n* 5\\. Received systemic immuno suppressive therapy within 4 weeks prior to randomization (excluding prophylactic use or chronic low-dose steroids \\[≤20 mg\u002Fday prednisone equivalent dose\\]);\n* 6\\. Currently taking or has recently taken (within 10 days prior to the first dose) aspirin (\\>325 mg\u002Fday);\n* 7\\. Active or chronic hepatitis B (HBsAg or HBcAb positive and HBV DNA≥2000 IU\u002FmL or ≥10000 copies\u002FmL) or hepatitis C infection (HCV antibody positive and HCV RNA≥ULN);\n* 8\\. Clinically significant cardiovascular disease within 6 months prior to the first administration of the study treatment;symptomatic coronary artery disease requiring medication; arrhythmia requiring medication (excluding asymptomatic atrial fibrillation with controlled ventricular rate); QTcF interval \\>470 ms at rest state; or uncontrolled hypertension or pulmonary hypertension;\n* 9\\. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.); clinically significant bleeding events, arterial or deep venous thrombotic events, or superficial venous thrombosis and intermuscular venous thrombosis requiring intervention within 6 months prior to enrollment;\n* 10\\. Participants with proteinuria (urine protein \\>2+ found during screening examinations; or urine protein 2+ with 24-hour urine protein quantification ≥1g\u002F24h);\n* 11\\. Participants with a history of intestinal obstruction (including incomplete intestinal obstruction) within 1 month prior to enrollment; participants with a history of abdominal fistula, gastrointestinal perforation, or abdominal abscess.","ALL","18 Years",{"count":155,"type":156},464,"ESTIMATED","INTERVENTIONAL",[159],"PHASE3","The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine\u002Ftipiracil tablets in colorectal cancer participants.\n\nThe primary goal of Phase III Study is to evaluate the efficacy of Suvemcitug in combination with trifluridine\u002Ftipiracil tablets in colorectal cancer participants. Researchers will compare Suvemcitug + trifluridine\u002Ftipiracil tablets with placebo (a look-alike substance that contains no drug)+ trifluridine\u002Ftipiracil tablets to see if Suvemcitug + trifluridine\u002Ftipiracil tablets works better in treating refractory metastatic colorectal cancer.",[162],"Refractory Metastatic Colorectal Cancer",[164,165,166],"refractory metastatic colorectal cancer","Suvemcitug","trifluridine\u002Ftipiracil","2026-01-14",{"date":169,"type":170},"2026-01-22","ACTUAL",{"date":172,"type":170},"2025-11-12",{"date":174,"type":156},"2028-07",{"name":5,"class":6},6]