[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581890":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":28,"locations":36,"responsibleParty":55,"collaborators":12,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":12,"maxAge":12,"enrollmentInfo":68,"targetDuration":12,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":39,"whyStopped":12,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Fudan University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Second-line standard therapy sequential TAS-102 and bevacizumab group","EXPERIMENTAL","Second-line induce therapy followed by TAS-102+bevacizumab maintainance therapy combined with local treatment",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Continuous therapy of Standard Treatment Group","ACTIVE_COMPARATOR","Continuous therapy of standard treatment regimen",[18],"Drug: Standard chemotherapy",[20,24],{"type":21,"name":22,"description":23,"armGroupLabels":12,"otherNames":12},"DRUG","TAS-102+bevacizumab+local treatment","patients achieve disease control after second-line induction therapy with standard therapy(FOLFOX\u002FFOLFIRI\u002FXELOX\u002F mXELIRI＋bevacizumab\u002Fcetuximab), then achieve TAS-102+bevacizumab+local treatment",{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":12},"Standard chemotherapy","Standard therapy：FOLFOX\u002FFOLFIRI\u002FXELOX\u002F mXELIRI±bevacizumab\u002Fcetuximab",[14],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":12,"email":33},"Wenhua Li, Ph.D","CONTACT","8618017317210","whliiris@hotmail.com",{"name":30,"role":31,"phone":35,"phoneExt":12,"email":33},"86 18017317210",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":46,"coordinates":47},"Point",[48,49],121.45806,31.22222,{"lat":49,"lon":48},[52],{"name":53,"role":31,"phone":54,"phoneExt":12,"email":12},"Jinjia Chang, PhD","86+18017317729",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Li Wenhua","Department of Medical Oncology, Fudan University Shanghai Cancer Center","100581890","phase-2-second-line-standard-treatment-sequential-tas-102-and-bevacizumab-combined-with-local-treatment-in-advanced-colorectal-cancer-100581890",false,"NCT06856187","Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer","A Randomized, Phase II Clinical Study of Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer","TASBEL","Inclusion Criteria:\n\n* Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;\n* Patients who have failed first-line standard therapy and are intended to receive second-line standard therapy;\n* At least one measurable lesion according to RECIST 1.1 criteria;\n* ECOG Performance Status 0-1;\n* Estimated life expectancy ≥3months;\n* Adequate major organ function;\n* Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance.\n\nExclusion Criteria:\n\n* Allergy to the investigational drug and\u002For its excipients;\n* Pregnant or lactating women;\n* Prior treatment with TAS-102;\n* Any CTCAE grade 2 or above toxicity caused by previous treatment that has not yet subsided (excluding alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity);\n* Known inherited or acquired bleeding (e.g., coagulopathy) or thrombophilia, as in patients with hemophilia; Current or recent (within 10 days before initiation of study treatment) use of a full-dose oral or injectable anticoagulant or thrombolytic agent for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed);\n* Serious illness, including but not limited to the following:\n\n  1. Patients with other malignant tumors within 5 years before enrollment, except basal cell carcinoma of the skin or carcinoma in situ of the cervix;\n  2. Known brain and\u002For leptomeningeal metastases;\n  3. Active infection or fever of unknown origin \\> 38.5 ° C ;\n  4. Poorly controlled hypertension (systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg) with a previous history of hypertensive crisis or hypertensive encephalopathy;\n  5. Known inherited or acquired bleeding (e.g., coagulopathy)\n  6. Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the initiation of study treatment;\n  7. Severe, unhealed or dehiscence wounds and active ulcers or untreated fractures;\n  8. Myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (NYHA Class III or IV) within the last 12 months;\n  9. Acute or subacute intestinal obstruction, or chronic inflammatory bowel disease;\n  10. There are serious psychological or psychiatric abnormalities that affect the compliance of patients to participate in this clinical study.\n* Has undergone major surgical treatment (excluding diagnosis) within 4 weeks before the start of the study or is expected to undergo major surgical treatment during the study period;\n* Inability to swallow pills, presence of malabsorption syndrome or any condition affecting gastrointestinal absorption;\n* The investigator assessed that it is not appropriate to participate in the study.","ALL",{"count":69,"type":70},119,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer.",[76],"Metastatic Colorectal Cancer (CRC)",[78,79,80,81],"Colorectal cancer","TAS-102","second-line therapy","maintainance therapy","2025-08-05",{"date":84,"type":85},"2025-08-06","ACTUAL",{"date":87,"type":85},"2025-02-28",{"date":89,"type":70},"2027-04-30",{"name":5,"class":6},1]