[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100309067":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":54,"centralContacts":55,"locations":61,"responsibleParty":89,"collaborators":54,"id":91,"slug":54,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":54,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":54,"enrollmentInfo":99,"targetDuration":54,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":112,"overallStatus":64,"whyStopped":54,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"FOLFIRI +\u002F- Bevacizumab","EXPERIMENTAL","Bevacizumab 5 mg\u002Fkg IV 90-30 min Day 1; CPT-11 180 mg\u002Fm2 IV 90 min Day 1; l-LV (dl-LV) 200 mg\u002Fm2 (400 mg\u002Fm2) IV 120 min Day 1; 5-FU - bolus 400 mg\u002Fm2 IV bolus Day 1; 5-FU - infusional 2400 mg\u002Fm2 IV continuous (46 hours) Day 1 - 3",[13,14,15,16,17],"Biological: Bevacizumab","Drug: CPT-11","Drug: 5-FU Bolus","Drug: 5-FU Infusion","Drug: l-LV (dl-LV)",{"label":19,"type":10,"description":20,"interventionNames":21},"CPT-11 +\u002F- Bevacizumab","Bevacizumab 5 mg\u002Fkg IV 90-30 min Day 1; CPT-11 180 mg\u002Fm2 IV 90 min Day 1",[13,14],[23,30,37,43,48],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","Bevacizumab","5 mg\u002Fkg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.",[19,9],[29],"Avastin",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","CPT-11","180 mg\u002Fm2 intravenously administered over 90 minutes on day 1 of a 2-week cycle",[19,9],[36],"Irinotecan",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"5-FU Bolus","400 mg\u002Fm2 intravenous bolus on day 1 of a 2-week cycle.",[9],[42],"fluorouracil",{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"5-FU Infusion","2400 mg\u002Fm2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.",[9],[42],{"type":31,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"l-LV (dl-LV)","200 (dl-LV: 400) mg\u002Fm2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.",[9],[53],"Leucovorin",null,[56],{"name":57,"role":58,"phone":59,"phoneExt":54,"email":60},"Ruihua Xu, MD, PhD","CONTACT","87343333","xurh@sysucc.org.cn",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Cancer center of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":71,"coordinates":72},"Point",[73,74],113.25,23.11667,{"lat":74,"lon":73},[77,80,84,86],{"name":78,"role":58,"phone":79,"phoneExt":54,"email":60},"Rui-Hua Xu, MD, PhD","86-020-87343333",{"name":81,"role":58,"phone":82,"phoneExt":54,"email":83},"De-shen Wang, MD, PhD","86-020-87343351","wangdsh@sysucc.org.cn",{"name":81,"role":85,"phone":54,"phoneExt":54,"email":54},"SUB_INVESTIGATOR",{"name":87,"role":88,"phone":54,"phoneExt":54,"email":54},"Rui-hua Xu, MD, PhD","PRINCIPAL_INVESTIGATOR",{"type":88,"investigatorFullName":87,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"Professor and President","100309067",false,"NCT03303495","A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC","A Multinational, Randomized, Phase III Study of FOLFIRI With\u002FWithout Bevacizumab Versus Irinotecan With\u002FWithout Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.\n2. Age ≥18 years at the time of informed consent\n3. ECOG performance status (PS) of 0-2\n4. Written informed consent prior to study-specific screening procedures\n5. Life expectancy of at least 90 days\n6. Withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy.\n7. Adequate organ function according to following laboratory values obtained within 14 days before enrolment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test) Neutrophil count: ≥1500\u002Fmm3 Platelet count: ≥10.0 x 104\u002Fmm3 Hemoglobin: ≥9.0 g\u002FdL Total bilirubin: ≤1.5 mg\u002FdL AST, ALT: ≤100 IU\u002FL (≤200 IU\u002FI if liver metastases present) Serum creatinine: ≤1.5 mg\u002FdL\n\nExclusion Criteria:\n\n1. History of other malignancy with a disease-free interval \\\u003C5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)\n2. With massive pleural effusion or ascites requiring intervention\n3. Radiological evidence of brain tumor or brain metastases\n4. Active infection including hepatitis\n5. Any of the following complication:\n\n   i) Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus) ii) Symptomatic heart disease (including unstable angina, myocardial infarction, and heart failure) iii) Interstitial pneumonia or pulmonary fibrosis iv) Uncontrolled diabetes mellitus v) Uncontrolled diarrhea (that interferes with daily activities despite adequate therapy)\n6. Any of the following medical history:\n\n   Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime episodes i) Serious hypersensitivity to any of the study drugs ii) History of adverse reaction to fluoropyrimidines suggesting dihydropyrimidine dehydrogenase (DPD) deficiency\n7. Previous treatment with irinotecan hydrochloride\n8. Current treatment with atazanavir sulfate\n9. Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment\n10. Pregnant or lactating females, and males and females unwilling to use contraception\n11. Requires continuous treatment with systemic steroids\n12. Psychiatric disability that would preclude study compliance\n13. Otherwise determined by the investigator to be unsuitable for participation in the study\n14. Concurrent gastrointestinal perforation or history of gastrointestinal perforation with 1 year before enrollment\n15. History of pulmonary hemorrhage\u002Fhemoptysis ≥ Grade 2 (defined as bright red blood of at least 2.5mL) within 1 month prior to enrollment.\n16. History of laparotomy, thoracotomy, or intestinal resection within 28 days before enrollment\n17. Unhealed wound (except suture wounds from implantation of a central venous port), gastrointestinal ulcer, or traumatic fracture\n18. Current or recent (within 1 year) thromboembolism or cerebrovascular disease\n19. Currently receiving or requires anticoagulation therapy (\\> 325 mg\u002Fday of aspirin)\n20. Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR ≥1.5 within 14 days before enrollment)\n21. Uncontrolled hypertension\n22. Urine dipstick for proteinuria \\>+2","ALL","18 Years",{"count":100,"type":101},280,"ESTIMATED","INTERVENTIONAL",[104],"PHASE3","The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.",[107,108,109,110,111],"Colorectal Neoplasms","Neoplasm Metastasis","Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms",[113,32,25,114],"FOLFIRI","2nd-line metastatic colorectal cancer","2026-06-03",{"date":117,"type":118},"2026-06-05","ACTUAL",{"date":120,"type":118},"2011-11-14",{"date":122,"type":101},"2026-12-31",{"name":5,"class":6},1]