[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623052":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":36,"responsibleParty":51,"collaborators":24,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":24,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"arm1","EXPERIMENTAL","For patients with wild-type RAS and BRAF and the primary lesion located in the left colorectum, the mFOLFOX6 or FOLFIRI regimens with simultaneous infusion of levofolinic acid and 5-FU for injection were received. Whether to combine cetuximab was determined by the researchers",[13],"Drug: mFOLFOX\u002FFOLFIRI ( Standard Chemotherapy)",{"label":15,"type":10,"description":16,"interventionNames":17},"arm2","For patients with both RAS and BRAF wild-type and with the primary lesion located in the right colorectal and\u002For RAS or BRAF mutant type, the mFOLFOX6 or FOLFIRI regimen with simultaneous infusion of levofolinic acid and 5-FU for injection, whether to combine bevacizumab, was determined by the researchers",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","mFOLFOX\u002FFOLFIRI ( Standard Chemotherapy)","mFOLFOX6: Oxaliplatin 85mg\u002Fm², intravenous infusion for 2 hours, day 1; 5-FU 400mg\u002Fm² injection, d1; Levofolic acid for injection at 200mg\u002Fm² and 5-FU at 2400mg\u002Fm² were mixed and infused simultaneously for 46 to 48 hours. Repeat every two weeks until disease progression or intolerable toxicity occurs. FOLFIRI: Irinotecan 180mg\u002Fm², intravenous infusion for 30 to 90 minutes on day 1; 5-FU 400mg\u002Fm² injection d1; Levofolic acid for injection at 200mg\u002Fm² and 5-FU at 2400mg\u002Fm² were mixed and infused simultaneously for 46 to 48 hours. Repeat every two weeks until disease progression or intolerable toxicity occurs.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Guanghai Dai","STUDY_CHAIR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":24,"email":33},"CONTACT","+861066947252","daigh301@vip.sina.com",{"name":35,"role":31,"phone":24,"phoneExt":24,"email":33},"miaomiao Gou",[37],{"facility":38,"status":39,"city":40,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Chinese PLA General Hospital, Beijing","RECRUITING","Beijing","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":27,"role":31,"phone":32,"phoneExt":24,"email":33},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Dai, Guanghai","Professor","100623052","phase-2-clinical-study-on-the-first-line-treatment-of-advanced-colorectal-cancer-with-simultaneous-infusion-of-levozolinate-for-injection-and-5-fu-100623052",false,"NCT07391618","Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU","A Study to Evaluate the Efficacy and Safety of a First-line Treatment for Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU","Inclusion Criteria:\n\n1. The subjects voluntarily joined this study and signed the informed consent form.\n2. Age: 18 to 75 years old, gender not limited;\n3. ECOG PS score: 0-2 points\n4. Patients with unresectable or metastatic colorectal cancer confirmed by histology or cytology, where the primary tumor location and the status of RAS and BRAF are known;\n5. No previous treatment for unresectable or metastatic lesions has been received;\n6. There is at least one measurable lesion in accordance with the RECIST 1.1 standard;\n7. In the pre-treatment examination indicators, there was no serious hematopoietic function abnormality, and the functions of the heart, lungs, liver and kidneys were basically normal.\n\n   1. Hemoglobin (Hb) ≥70 g\u002FL;\n   2. White blood cell count (WBC) ≥3.0×109\u002FL; Neutrophil count (NEUT) ≥1.5×109\u002FL;\n   3. Platelet count (PLT) ≥100×109\u002FL;\n   4. Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level ≤2.5 times the upper limit of normal value (ULN); Renal function (serum creatinine sCr) level ≤1.5 times the upper limit of the normal value (ULN). Total bilirubin (TBIL) ≤1.5 times the upper limit of the normal value (ULN).\n8. The expected survival period is more than three months.\n\nExclusion Criteria:\n\n1. Those who have been confirmed to be allergic to the test drug and\u002For its excipients;\n2. Those with contraindications to chemotherapy;\n3. Colorectal cancer patients with MSI-H or dMMR;\n4. Pregnant or lactating women;\n5. There is a history of other malignant tumors in the past;\n6. Those with systemic internal diseases and mental disorders who are not suitable for chemotherapy;\n7. Patients who were determined by the researchers to be unsuitable for inclusion in this study.","ALL","18 Years","75 Years",{"count":66,"type":67},583,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","Phase II study of simultaneous infusion of levozolinate for injection and 5-FU as first-line treatment for advanced colorectal cancer",[73],"Advanced Colorectal Cancer",[75],"levozolinate","2026-01-29",{"date":78,"type":79},"2026-02-06","ACTUAL",{"date":81,"type":79},"2025-05-15",{"date":83,"type":67},"2029-12",{"name":5,"class":6},1]