[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640989":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":51,"centralContacts":56,"locations":61,"responsibleParty":80,"collaborators":30,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":30,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":30,"enrollmentInfo":91,"targetDuration":30,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":102,"whyStopped":30,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"FOLFOX8","EXPERIMENTAL","Patients receive oxaliplatin, 5-FU bolus, and a concurrent infusion of Levofolinic Acid For Injection mixed with 5-FU, repeated every 2 weeks for up to 12 cycles. From cycle 2 onward, bevacizumab or cetuximab is added based on RAS mutation status and tumor location. After 12 cycles, patients without disease progression enter maintenance therapy with concurrent infusion of Levofolinic Acid For Injection mixed with 5-FU (without oxaliplatin) plus continued targeted therapy , repeated every 2 weeks until disease progression or unacceptable toxicity.",[13,14,15,16,17],"Drug: Oxaliplatin","Drug: 5-Fluorouracil","Drug: Levofolinic Acid For Injection","Drug: Bevacizumab","Drug: Cetuximab (EGFR inhibitor)",{"label":19,"type":20,"description":21,"interventionNames":22},"mFOLFOX6","ACTIVE_COMPARATOR","Patients receive oxaliplatin, calcium folinate, 5-FU bolus, and 5-FU continuous infusion, repeated every 2 weeks for up to 12 cycles. From cycle 2 onward, bevacizumab or cetuximab is added based on RAS mutation status and tumor location. After 12 cycles, patients without disease progression enter maintenance therapy with calcium folinate, 5-FU bolus, and 5-FU continuous infusion (without oxaliplatin) plus continued targeted therapy , repeated every 2 weeks until disease progression or unacceptable toxicity.",[13,14,23,16,17],"Drug: Calcium Folinate",[25,31,35,39,43,47],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Oxaliplatin","85 mg\u002Fm² intravenously over 2 hours on Day 1, every 2 weeks for up to 12 cycles. For patients without disease progression after 12 cycles, oxaliplatin is discontinued and not used in maintenance.",[9,19],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"5-Fluorouracil","400 mg\u002Fm² intravenous bolus on Day 1, followed by 2400 mg\u002Fm² administered as a continuous intravenous infusion over 46-48 hours. Cycle repeats every 2 weeks for up to 12 cycles. Patients without disease progression then enter maintenance with the same 5-FU regimen every 2 weeks until disease progression or unacceptable toxicity.",[9,19],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Levofolinic Acid For Injection","200 mg\u002Fm² mixed with 5-FU 2400 mg\u002Fm² as a continuous intravenous infusion over 46-48 hours on Day 1 (concurrent infusion). Cycle repeats every 2 weeks for up to 12 cycles. Patients without disease progression then enter maintenance with the same mixture every 2 weeks until disease progression or unacceptable toxicity.",[9],{"type":26,"name":40,"description":41,"armGroupLabels":42,"otherNames":30},"Calcium Folinate","400 mg\u002Fm² intravenously over 2 hours on Day 1, administered sequentially before 5-FU. Cycle repeats every 2 weeks for up to 12 cycles. Patients without disease progression then enter maintenance with the same dose and schedule of calcium folinate (without oxaliplatin) every 2 weeks until disease progression or unacceptable toxicity.",[19],{"type":26,"name":44,"description":45,"armGroupLabels":46,"otherNames":30},"Bevacizumab","5 mg\u002Fkg intravenously on Day 1 every 2 weeks, starting from Cycle 2 (after genetic testing results are available). Continue through induction and maintenance until disease progression or unacceptable toxicity.",[9,19],{"type":26,"name":48,"description":49,"armGroupLabels":50,"otherNames":30},"Cetuximab (EGFR inhibitor)","500 mg\u002Fm² intravenously over more than 2 hours on Day 1 every 2 weeks, starting from Cycle 2 (after genetic testing results are available). Continue through induction and maintenance until disease progression or unacceptable toxicity.",[9,19],[52],{"name":53,"affiliation":54,"role":55},"Feng Wang","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[57],{"name":53,"role":58,"phone":59,"phoneExt":30,"email":60},"CONTACT","+86 020 87343795","wangfeng@sysucc.org.cn",[62],{"facility":63,"status":30,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510000","China","CN",{"type":70,"coordinates":71},"Point",[72,73],113.25,23.11667,{"lat":73,"lon":72},[76,78],{"name":77,"role":58,"phone":59,"phoneExt":30,"email":60},"Feng Wang, MD, PhD",{"name":30,"role":58,"phone":30,"phoneExt":30,"email":79},"wangzhq@sysucc.org.cn",{"type":55,"investigatorFullName":53,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Professor and Chief Physician, Department Director","100640989","phase-2-folfox8-versus-mfolfox6-with-bevacizumab-or-cetuximab-for-first-line-unresectable-metastatic-colorectal-cancer-phase-ii-100640989",false,"NCT07621497","FOLFOX8 Versus mFOLFOX6 With Bevacizumab or Cetuximab for First-Line Unresectable Metastatic Colorectal Cancer (Phase II)","A Prospective, Multicenter, Randomized Controlled, Phase II Study to Evaluate the Efficacy and Safety of FOLFOX8 Versus mFOLFOX6 Combined With Bevacizumab or Cetuximab as First-Line Treatment for Unresectable Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female.\n2. ECOG performance status 0-2.\n3. Histologically or cytologically confirmed unresectable metastatic colorectal cancer with no prior treatment for unresectable or metastatic disease.\n4. Adequate organ function: Hb ≥ 70 g\u002FL; WBC ≥ 3.0×10⁹\u002FL; NEUT ≥ 1.5×10⁹\u002FL; PLT ≥ 75×10⁹\u002FL; AST and ALT ≤ 3× ULN; sCr ≤ 2× ULN; TBIL ≤ 2× ULN.\n5. Expected survival \\> 3 months.\n\nExclusion Criteria:\n\n1. Known allergy to the study drug(s) and\u002For their excipients.\n2. Contraindications to chemotherapy.\n3. Patients with MSI-H or dMMR colorectal cancer.\n4. Patients with BRAF mutation.\n5. Pregnant or breastfeeding women.\n6. History of any second malignancy within 2 years prior to randomization, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, or breast carcinoma in situ, which are allowed for enrollment.\n7. Patients with systemic medical or psychiatric disorders that make them unsuitable for chemotherapy.\n8. Patients deemed unsuitable for enrollment in this study by the investigator's judgment.\n9. Participation in another clinical trial of an investigational drug within 4 weeks prior to randomization.","ALL","18 Years",{"count":92,"type":93},229,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","This is a prospective, multicenter, randomized controlled, phase II study. It is expected to enroll 229 patients and aims to evaluate the efficacy and safety of FOLFOX8 versus mFOLFOX6 combined with bevacizumab or cetuximab as first-line treatment for unresectable metastatic colorectal cancer. The primary objective is to assess progression-free survival (PFS) of the patients. Secondary objectives include assessment of objective response rate (ORR), overall survival (OS), safety, and other outcomes.",[99],"Metastatic Colorectal Cancer (CRC)",[9,36,101],"First-line treatment","NOT_YET_RECRUITING","2026-05-31",{"date":105,"type":106},"2026-06-02","ACTUAL",{"date":108,"type":93},"2026-06-01",{"date":110,"type":93},"2030-06-01",{"name":5,"class":6},1]