[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535711":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":45,"collaborators":11,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":11,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":73,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Guangzhou University of Traditional Chinese Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fuquinitinib +Tegafur Gimeracil Oteracil","EXPERIMENTAL",null,[13],"Drug: Fuquinitinib+Tegafur Gimeracil Oteracil",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Fuquinitinib+Tegafur Gimeracil Oteracil","Fuquinitinib:5 mg once daily, 2 weeks on\u002F1 week off,q3w; Tegafur Gimeracil Oteracil:BSA(body surface area)\\\u003C 1.2m2,40mg\u002Fm2,p.o,bid,2 weeks on\u002F1 week off,q3w; 1.2m2 \\\u003C BSA （body surface area）\\\u003C 1.5m2,50mg\u002Fm2,p.o,bid,2 weeks on\u002F1 week off,q3w;BSA（body surface area） \\>1.5m2,60mg\u002Fm2,p.o,bid,2 weeks on\u002F1 week off,q3w;",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Yang xiaobing, PhD","CONTACT","+86 135-8030-9705","yangxiaobing2002@126.com",[27],{"facility":28,"status":11,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Guangdong Provincial Hospital of Traditional Chinese Medicine","Guangzhou","Guangdong","510000","China","CN",{"type":35,"coordinates":36},"Point",[37,38],113.25,23.11667,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":43,"phoneExt":44,"email":11},"Li xiaoyan","+86 020-81887233","35943",{"type":46,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100535711","phase-2-study-of-fruquintinib-combined-with-tegafur-gimeracil-oteracil-in-patients-with-metastatic-colorectal-cancer-100535711",false,"NCT06255379","Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer","An Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC","Inclusion Criteria:\n\n1. ≥ 18 and ≤ 75 years of age;\n2. Have fully understood and voluntarily sign the ICF for this study (the icf must be signed before any trial-specific procedures are performed);Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;\n3. Histologically and\u002For cytologically documented metastatic colorectal adenocarcinoma;\n4. Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;\n5. At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);\n6. ECOG performance status of 0-1;\n7. Life expectancy ≥ 12 weeks;\n8. No previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitor (TKI);\n9. Adequate hepatic, renal, heart, and hematologic functions;\n10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;\n3. Previous treatment with Tegafur Gimeracil Oteracil ;\n4. Participated in clinical trials of other drugs within four weeks before enrollment;\n5. Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;\n6. International normalized ratio (INR) \\> 1.5 or partially activated prothrombin time (APTT) \\> 1.5 × ULN;\n7. Clinically significant electrolyte abnormalities;\n8. Subjected with hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and \u002F or diastolic blood pressure ≥ 90 mmHg;\n9. Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment;\n10. Incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture;\n11. Conditions that may cause gastrointestinal bleeding and perforation determined by the researcher;\n12. History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment;\n13. Stroke and \u002F or transient cerebral ischemia occurred within 12 months before enrollment;\n14. Cardiovascular diseases with significant clinical significance;\n15. LVEF\\\u003C50%;\n16. Congestive heart failure New York Heart Association (NYHA) grade \\> 2;\n17. Evidence of CNS metastasis;\n18. Previous treatment with VEGFR inhibition;\n19. Ventricular arrhythmias requiring drug treatment;\n20. Proteinuria ≥ 2+ (1.0g\u002F24hr);\n21. Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy;\n22. Other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;\n23. Active infection that is not controlled clinically, such as acute pneumonia, active hepatitis B or hepatitis C;\n24. By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.","ALL","18 Years","75 Years",{"count":58,"type":59},52,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC",[65,66,67],"Metastasis Colorectal Cancer","Colon Cancer","Rectal Cancer",[69,70,71,72],"Colorectal cancer","Fruquintinib","Tegafur Gimeracil Oteracil","mCRC","NOT_YET_RECRUITING","2024-04-26",{"date":76,"type":77},"2024-04-29","ACTUAL",{"date":79,"type":59},"2024-05-06",{"date":81,"type":59},"2027-03-21",{"name":5,"class":6},1]