[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457672":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":26,"responsibleParty":45,"collaborators":26,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":26,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":26,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":26,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":26},{"fullName":5,"class":6},"Shanghai Henlius Biotech","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"A：1L treatment","EXPERIMENTAL","HLX07 \\* 1000 mg+HLX10\\* 200mg +mFOLFOX6, IV, Q2W",[13,14,15],"Drug: HLX07","Drug: HLX10","Drug: mFOLFOX6",{"label":17,"type":10,"description":18,"interventionNames":19},"B：≥2L treatment","HLX07 \\*1000 mg monotherapy,IV, Q2W",[13],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","HLX07","1000mg",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"HLX10","200mg",[9],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"mFOLFOX6","OXA：85 mg\u002Fm2;LV:400 mg\u002Fm2；5-FU：400 mg\u002Fm2",[9],[36],{"name":37,"affiliation":38,"role":39},"Peng Junjie","Fudan University Affiliated Oncology Hospital","PRINCIPAL_INVESTIGATOR",[41],{"name":37,"role":42,"phone":43,"phoneExt":26,"email":44},"CONTACT",": 86021-64175590","junjiepeng67@163.com",{"type":46,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100457672","phase-2-phase-ii-clinical-study-to-evaluate-the-efficacy-and-safety-of-hlx07hlx10-mfolfox6-or-hlx07-monotherapy-in-patients-with-mcrc-100457672",false,"NCT05239650","Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC","An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Age\\>=18Y and ≤75Y\n* Good Organ Function\n* Expected survival time ≥ 3 months\n* mCRC that have been diagnosed histologically\n* KRAS\u002FNRAS\u002FBRAF WT verified by PCR or NGS of tumor tissue\n* ECOG score 0-1;\n\nExclusion Criteria:\n\n* HIV infection\n* Active clinical severe infection;\n* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.","ALL","18 Years","75 Years",{"count":58,"type":59},50,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.",[65],"CRC","NOT_YET_RECRUITING","2022-05-01",{"date":69,"type":70},"2022-05-03","ACTUAL",{"date":72,"type":59},"2022-07-15",{"date":74,"type":59},"2026-10-15",{"name":5,"class":6}]