[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648959":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":42,"locations":51,"responsibleParty":67,"collaborators":46,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":46,"enrollmentInfo":80,"targetDuration":46,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":94,"whyStopped":46,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: FOLFIRI + Bevacizumab + QL1706","EXPERIMENTAL","Patients will receive FOLFIRI plus Bevacizumab and QL1706, repeat once every 2 weeks. After 8 cycles of induction therapy, patients without disease progression will receive 5-FU, bevacizumab and QL1706 as maintenance therapy till disease progression.",[13],"Drug: FOLFIRI + bevacizumab + QL1706",{"label":15,"type":16,"description":17,"interventionNames":18},"Control: FOLFIRI + Bevacizumab","ACTIVE_COMPARATOR","Patients will receive FOLFIRI plus Bevacizumab, repeat once every 2 weeks. After 8 cycles of induction therapy, patients without disease progression will receive 5-FU and bevacizumab as maintenance therapy till disease progression.",[19],"Drug: FOLFIRI + bevacizumab",[21,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","FOLFIRI + bevacizumab + QL1706","QL1706 (4mg\u002Fkg on day 1), Bevacizumab (5 mg\u002Fkg on day 1) plus mFOLFIRI ( irinotecan 180 mg\u002Fm2, and folinic acid 400 mg\u002Fm2 followed by bolus 5-fluorouracil 400 mg\u002Fm2 and 5-fluorouracil 2400mg\u002Fm2 as a 46-hour continuous infusion on day 1) for 8 cycles and followed by QL1706 plus bevacizumab and fluoropyrimidine based maintence treatment.",[9],[27,28,29,30,31],"QL1706","Irinotecan","5-Fluorouracil","Leucovorin","Bevacizumab",{"type":22,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"FOLFIRI + bevacizumab","Bevacizumab (5 mg\u002Fkg on day 1) plus mFOLFIRI ( irinotecan 180 mg\u002Fm2, and folinic acid 400 mg\u002Fm2 followed by bolus 5-fluorouracil 400 mg\u002Fm2 and 5-fluorouracil 2400mg\u002Fm2 as a 46-hour continuous infusion on day 1) for 8 cycles and followed by bevacizumab and fluoropyrimidine based maintence treatment.",[15],[31,29,30,28],[38],{"name":39,"affiliation":40,"role":41},"Yanhong Deng, PhD","Sixth Affiliated Hospital, Sun Yat-sen University","PRINCIPAL_INVESTIGATOR",[43,48],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","86-13925106525",null,"dengyanh@mail.sysu.edu.cn",{"name":49,"role":44,"phone":46,"phoneExt":46,"email":50},"Jianwei Zhang, doctor","zhangjw25@mail.sysu.edu.cn",[52],{"facility":53,"status":46,"city":54,"state":55,"zip":46,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"The sixth affiliated hospital of Sun Yat-sen University","Guangzhou","Guangdong","China","CN",{"type":59,"coordinates":60},"Point",[61,62],113.25,23.11667,{"lat":62,"lon":61},[65,66],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},{"name":39,"role":41,"phone":46,"phoneExt":46,"email":46},{"type":41,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Yanhong Deng","Professor","100648959","phase-3-folfiri-plus-bevacizuamb-and-ql1706-in-second-line-treatment-for-mcrc-100648959",false,"NCT07729605","FOLFIRI Plus Bevacizuamb and QL1706 in Second-Line Treatment for mCRC","FOLFIRI Plus Bevacizuamb With or Without Iparomlimab and Tuvonralimab as Second-Line Treatment for Metastatic Colorectal Cancer: A Randomized Controlled Trial","FIRBIT","Inclusion Criteria:\n\n* 1\\. Willing and able to provide written informed consent. 2. Age ≥ 18 years old. 3.Histologically confirmed metastatic colorectal adenocarcinoma with pMMR\u002FMSS status. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5.Discontinued first-line oxaliplatin-based doublet chemotherapy for metastatic colorectal cancer due to intolerable toxicities or disease progression; OR developed recurrent metastatic disease within 6 months after the last dose of adjuvant chemotherapy. 6.Presence of evaluable lesions on imaging examinations. 7. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment. 8.Willing and able to comply with study procedures and scheduled visit schedules\n\nExclusion Criteria:\n\n* 1.Patients complicated with digestive tract diseases including duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions judged by the investigator to potentially cause gastrointestinal hemorrhage or perforation; or massive pleural effusion or ascites requiring intervention. 2.Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization. 3. Radiological evidence of brain metastases. 4. Prior treatment with irinotecan hydrochloride, or prior receipt of PD-1 and\u002For CTLA-4 immunotherapy in the first-line setting. 5. Autoimmune diseases requiring continuous systemic steroid therapy. 6. History of laparotomy, thoracotomy or intestinal resection within 28 days prior to enrollment; or unhealed wounds (excluding suture wounds from central venous catheter implantation), gastrointestinal ulcers or traumatic fractures. 7. Any of the following events occurring within 12 months before study enrollment: myocardial infarction, severe\u002Funstable angina pectoris, New York Heart Association (NYHA) class ≥ 2 cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure. 8.Confirmed human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases. 9. Active inflammatory bowel disease or other colorectal diseases causing chronic diarrhea; interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, acute pneumonia, etc.). 10. Breastfeeding or pregnant women; lack of effective contraceptive. 11. Other severe physical or psychiatric illnesses, or laboratory abnormalities that may increase the risks of study participation or interfere with study outcomes; or patients deemed unsuitable for this study by the investigator.","ALL","18 Years",{"count":81,"type":82},270,"ESTIMATED","INTERVENTIONAL",[85],"PHASE3","Thsi study is a randomised, parallel-controlled phase II\u002FIII trial evaluating FOLFIRI plus bevacizumab with or without QL1706 as second-line therapy for metastatic colorectal cancer. The primary endpoint is PFS. Secondary endpoint includes overall survival, objective response rate, safety profiles, immune-related adverse events, and patient quality of life. Exploratory analyses focus on dynamic shifts in tumour immune microenvironment and biomarkers, aiming to identify predictive signatures for therapeutic efficacy and immune toxicities.",[88,89],"Colorectal Cancer Metastatic","Microsatellite Stable (MSS) Colorectal Cancer (CRC)",[91,27,31,92,93],"PD-1\u002FCTLA-4","FOLFIRI","Second-line","NOT_YET_RECRUITING","2026-07-22",{"date":97,"type":98},"2026-07-27","ACTUAL",{"date":100,"type":82},"2026-07-30",{"date":102,"type":82},"2029-07-30",{"name":5,"class":6},1]