[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568749":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":28,"centralContacts":28,"locations":33,"responsibleParty":52,"collaborators":28,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":28,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":28,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":28,"overallStatus":36,"whyStopped":28,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study arm","EXPERIMENTAL","Fruquintinib Sintilimab Chidamide\n\nTreatments are administered until disease progression or toxicity intolerable.",[13,14,15],"Drug: Fruquintinib","Drug: Sintilimab","Drug: Chidamide",[17,24,29],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Fruquintinib","Fruquintinib: 5mg qd, po, 2 weeks on\u002F1 week off, q3w, or 3mg qd, po, q3w.",[9],[23],"hmpl-013",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Sintilimab","Sintilimab: 200mg, iv, d1, q3w.",[9],null,{"type":18,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Chidamide","Chidamide: 30mg\u002Fm2, po, biw.",[9],[34],{"facility":35,"status":36,"city":37,"state":28,"zip":28,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"China PLAGH","RECRUITING","Beijing","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":50,"phoneExt":28,"email":51},"Guanghai Dai, M.D.","CONTACT","13801232381","daigh301@vip.sina.com",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Dai, Guanghai","Chief Physician","100568749","phase-2-safety-and-efficacy-of-fruquintinib-plus-chidamide-and-sintilimab-in-the-third-and-later-line-treatment-of-msspmmr-metastatic-colorectal-cancer-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":67,"type":68},46,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74],"Colorectal Cancer Metastatic","2024-11-17",{"date":77,"type":78},"2024-11-20","ACTUAL",{"date":80,"type":78},"2024-08-16",{"date":82,"type":68},"2026-12",{"name":54,"class":6},1]