[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603617":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":85,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Lepu Biopharma Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm","EXPERIMENTAL","Interventions administered to this arm include MRG004A, which is the investigational drug product, plus best supportive care, including but not limited to pain management, nutrition support, and psychological therapy",[13],"Drug: MRG004A plus best supportive care",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","PLACEBO_COMPARATOR","Placebo plus best supportive care, the definition of best supportive care is the same as that in the experiment arm",[19],"Drug: Placebo plus best supportive care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","MRG004A plus best supportive care","MRG004A will be administrated as specified in the protocol.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo plus best supportive care","Placebo will be administrated as specified in the protocol, following the same dose regimen as MRG004A.",[15],[32],{"name":33,"affiliation":34,"role":35},"Xianjun Yu, M.D.","Fudan University","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Program Director","CONTACT","86-21-61637960","clinicaltrials@miracogen.com.cn",[43],{"facility":44,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200032","China","CN",{"type":51,"coordinates":52},"Point",[53,54],121.45806,31.22222,{"lat":54,"lon":53},[57],{"name":33,"role":39,"phone":58,"phoneExt":26,"email":59},"86-21-64175590","yuxianjun@fudanpci.org",{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100603617","phase-3-a-study-comparing-mrg004a-plus-best-supportive-care-versus-placebo-and-best-supportive-care-in-the-treatment-of-patients-with-advanced-pancreatic-cancer-100603617",false,"NCT07138846","A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer","A Randomized, Double-blind, Multi-center, Phase III Study of MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* Willing to sign the informed consent form and follow the requirements specified in the protocol.\n* Patients with histologically and cytologically confirmed locally advanced or metastatic pancreatic cancer, including adenocarcinoma, who have failed at least prior systemic therapies including gemcitabine and fluorouracil.\n* Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n* The score of ECOG for performance status is 0 to 2.\n* Organ functions and coagulation function must meet the basic requirements.\n* Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.\n\nExclusion Criteria:\n\n* History of other primary malignant tumors\n* Active metastasis to brain or meninges\n* Active acute or chronic inflammatory skin disease, history of Steven-Johnson syndromes\n* History of active or chronic corneal and conjunctival diseases, or other clinically significant ocular diseases that affect the ophthalmic monitoring of the investigational drug\n* Received certain anti-tumor therapies or strong CYP3A4 inhibitors and have not complete the wash-out period, or have not fully recovered from major surgery\n* AEs due to prior anti-tumor therapy(ies) that have not resolved to ≤Grade 1 per CTCAE v5.0\n* Presence of ≥Grade 2 peripheral neuropathy per CTCAE v5.0\n* Poorly controlled pleural and peritoneal effusion or pericardial effusion\n* Severe cardiac dysfunction within 6 months before enrollment\n* History of ventricular tachycardia, or torsade des pointes\n* Uncontrolled or poorly controlled hypertension\n* Compression fractures of the spine that have not been treated with surgery and\u002For radiation therapy, or have not been stable within 2 weeks before randomization\n* Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.\n* Patients with high risk of bleeding per investigator's judgement.\n* Patients who have active infection including but not limited to hepatitis B, hepatitis C, AIDS, or syphilis.\n* Active uncontrolled bacterial, viral, fungal, rickettsial, or parasitic infection.\n* Moderate to severe dyspnea at rest, severe primary lung disease, interstitial lung disease, or pneumonia.\n* Uncontrolled pain due to cancer\n* Active or history of autoimmune disease that requiring systemic hormone therapy\n* History of hypersensitivity to any component of the investigational product.\n* Other situations that are not suitable to participate a clinical trial per investigator's judgement","ALL","18 Years",{"count":72,"type":73},231,"ESTIMATED","INTERVENTIONAL",[76],"PHASE3","This is a randomized, double-blind, multi-center, phase III study to evaluate the efficacy and safety, pharmacokinetic profile and immunogenicity of MRG004A in patients with advanced pancreatic cancer.",[79],"Advanced Pancreatic Cancer",[81,82,83,84],"MRG004A","Best Supportive Care","Placebo Controlled","Pancreatic Cancer","NOT_YET_RECRUITING","2026-05-12",{"date":88,"type":89},"2026-05-15","ACTUAL",{"date":91,"type":73},"2027-01",{"date":93,"type":73},"2027-06",{"name":5,"class":6},1]