[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568749":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":33,"interventions":42,"overallOfficials":26,"centralContacts":26,"locations":58,"responsibleParty":77,"collaborators":26,"id":81,"slug":26,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":26,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":26,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":26,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Progress-free Survival(PFS)","The time from enrollment until tumor progression or death from any cause, whichever occurred first","24 months",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Objective response rate (ORR)","The proportion of patients with a PR or CR",{"measure":18,"description":19,"timeFrame":12},"Overall Survival (OS)","The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date",{"measure":21,"description":22,"timeFrame":12},"Disease control rate (DCR)","The proportion of patients with a PR, CR, or SD",{"measure":24,"description":25,"timeFrame":12},"Duration of response (DoR)","For patients who achieved a complete response (CR) or partial response (PR), the time from the first tumor assessment demonstrating response until disease progression or death, whichever occurred first",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"Study arm","EXPERIMENTAL","Fruquintinib Sintilimab Chidamide\n\nTreatments are administered until disease progression or toxicity intolerable.",[39,40,41],"Drug: Fruquintinib","Drug: Sintilimab","Drug: Chidamide",[43,50,54],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DRUG","Fruquintinib","Fruquintinib: 5mg qd, po, 2 weeks on\u002F1 week off, q3w, or 3mg qd, po, q3w.",[35],[49],"hmpl-013",{"type":44,"name":51,"description":52,"armGroupLabels":53,"otherNames":26},"Sintilimab","Sintilimab: 200mg, iv, d1, q3w.",[35],{"type":44,"name":55,"description":56,"armGroupLabels":57,"otherNames":26},"Chidamide","Chidamide: 30mg\u002Fm2, po, biw.",[35],[59],{"facility":60,"status":61,"city":62,"state":26,"zip":26,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"China PLAGH","RECRUITING","Beijing","China","CN",{"type":66,"coordinates":67},"Point",[68,69],116.39723,39.9075,{"lat":69,"lon":68},[72],{"name":73,"role":74,"phone":75,"phoneExt":26,"email":76},"Guanghai Dai, M.D.","CONTACT","13801232381","daigh301@vip.sina.com",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Dai, Guanghai","Chief Physician","100568749",false,"NCT06685276","Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS\u002FpMMR Metastatic Colorectal Cancer","A Prospective Single-arm Phase Ib\u002FII Study on the Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS\u002FpMMR Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Fully understand this study and voluntarily sign the informed consent form;\n2. Age between 18-75 years inclusive;\n3. Patients with histologically confirmed unresectable locally advanced, recurrent, or metastatic colorectal adenocarcinoma;\n4. Failure of standard second-line systemic treatment with measurable lesions;\n5. Tumor tissue tested for microsatellite stability (MSS) or low microsatellite instability (MSI-L) by PCR, or confirmed pMMR by immunohistochemistry for DNA mismatch repair (MMR) protein (including MLH1, MSH2, MSH6, and PMS2 protein expression);\n6. ECOG performance status of 0-2, with no deterioration within 7 days;\n7. BMI≥18;\n8. Expected survival ≥3 months;\n9. Major organ functions meet the following requirements (no use of any blood components and growth factors within 14 days before enrollment):\n\n   * Absolute neutrophil count ≥1.5×109\u002FL, white blood cells ≥4.0×109\u002FL;\n   * Platelets ≥100×109\u002FL;\n   * Hemoglobin ≥90g\u002FL;\n   * Total bilirubin TBIL ≤1.5 times ULN;\n   * ALT and AST ≤5 times ULN;\n   * Urea\u002FBUN and creatinine (Cr) ≤1.5×ULN (and creatinine clearance (CCr) ≥ 50mL\u002Fmin);\n   * Left ventricular ejection fraction (LVEF) ≥50%;\n   * Corrected QT interval by Fridericia's formula (QTcF) \\\u003C470 milliseconds.\n   * INR ≤1.5×ULN, APTT ≤1.5×ULN.\n10. Women of childbearing age must use effective contraception;\n11. Good compliance and cooperation with follow-up.\n\nExclusion Criteria:\n\n1. Unable to comply with the study protocol or procedures;\n2. Pregnant or breastfeeding women;\n3. Concurrent with any of the following conditions: uncontrolled hypertension, coronary artery disease, arrhythmias, and heart failure;\n4. Previous treatment with small molecule tyrosine kinase inhibitors for metastatic disease;\n5. Previous treatment with romidepsin;\n6. Previous treatment with immune checkpoint inhibitors for metastatic disease;\n7. Uncontrollable severe concurrent infections;\n8. Acute myocardial infarction, acute coronary syndrome, or CABG within 3 months before the first treatment;\n9. Subjects allergic to the study medication or any of its excipients;\n10. Known human immunodeficiency virus (HIV) infection. Known clinically significant liver disease history, including viral hepatitis \\[known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e., HBV DNA positive (\\>1×10\\^4 copies\u002FmL or \\>2000 IU\u002FmL); known hepatitis C virus (HCV) infection and HCV RNA positive (\\>1×10\\^3 copies\u002FmL)\\];\n\n12\\. Patients whom the investigator deems inappropriate for inclusion in this study.","ALL","18 Years","75 Years",{"count":91,"type":92},46,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The prognosis of most patients with unresectable locally advanced or metastatic colorectal cancer (CRC) remains poor despite the advancements in chemotherapy and target therapy.\n\nCAPability-01 trial investigated the potential efficacy of combining the programmed cell death protein-1 (PD-1) monoclonal antibody sintilimab with the histone deacetylase inhibitor (HDACi) chidamide with or without the anti-vascular endothelial growth factor (VEGF) monoclonal antibody bevacizumab in patients with unresectable chemotherapy-refractory locally advanced or metastatic microsatellite stable\u002Fproficient mismatch repair (MSS\u002FpMMR) colorectal cancer.\n\nBased on the previous findings of CAPability-01, we will further evaluate the efficacy and safety of sintilimab and chidamide in combination with fruquintinib in the same setting.",[98],"Colorectal Cancer Metastatic","2024-11-17",{"date":101,"type":102},"2024-11-20","ACTUAL",{"date":104,"type":102},"2024-08-16",{"date":106,"type":92},"2026-12",{"name":79,"class":6},1]