[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605266":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":20,"responsibleParty":35,"collaborators":20,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":20,"eligibilityCriteria":42,"healthyVolunteers":39,"sex":43,"minAge":44,"maxAge":20,"enrollmentInfo":45,"targetDuration":20,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":20,"overallStatus":55,"whyStopped":20,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":20},{"fullName":5,"class":6},"The Second Affiliated Hospital of Shandong First Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Trilaciclib combined with chemotherapy for the treatment of advanced cholangiocarcinoma and pancreat","EXPERIMENTAL","Trilaciclib: 240 mg\u002Fm², administered via intravenous infusion over 30 minutes, completed within 4 hours prior to chemotherapy on the same day.\n\nChemotherapy Agents: Investigators will select chemotherapy regimens based on individual patient status. Regimens must be single-day protocols (including but not limited to gemcitabine, nab-paclitaxel, etc.), with dosing and administration per prescribing information.\n\nSubjects receiving concomitant immunotherapy or targeted therapy in addition to chemotherapy are eligible for enrollment.",[13,14],"Drug: Bile duct cancer cohort","Drug: Pancreatic cancer cohort",[16,21],{"type":17,"name":18,"description":11,"armGroupLabels":19,"otherNames":20},"DRUG","Bile duct cancer cohort",[9],null,{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"Pancreatic cancer cohort","rilaciclib: 240 mg\u002Fm², administered via intravenous infusion over 30 minutes, completed within 4 hours prior to chemotherapy on the same day.\n\nChemotherapy Agents: Investigators will select chemotherapy regimens based on individual patient status. Regimens must be single-day protocols (including but not limited to gemcitabine, nab-paclitaxel, etc.), with dosing and administration per prescribing information.\n\nSubjects receiving concomitant immunotherapy or targeted therapy in addition to chemotherapy are eligible for enrollment.",[9],[26],{"name":27,"affiliation":5,"role":28},"yan hai Liu","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":20,"email":34},"Yu E Miao, Doctor","CONTACT","17553832219","miaoyue0626@126.com",{"type":36,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100605266","phase-2-the-efficacy-and-safety-of-trilaciclib-in-bone-marrow-protection-before-chemotherapy-for-advanced-bile-duct-cancer-and-pancreatic-cancer-100605266",false,"NCT07160283","The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer","Inclusion Criteria:\n\n1. Age \\>18 years, male or female.\n2. Pathologically confirmed diagnosis of cholangiocarcinoma or pancreatic cancer requiring chemotherapy-based treatment.\n3. ECOG performance status ≥0 (or 1), anticipated survival ≥3 months, and ability to complete ≥3 months of follow-up.\n4. No clinically significant abnormalities in complete blood count, hepatic\u002Frenal function, cardiac enzymes, or electrocardiogram (ECG).\n5. Voluntary participation with good compliance and willingness to undergo safety and survival follow-up.\n6. Signed written informed consent form prior to enrollment.\n\nExclusion Criteria:\n\n1. History of myeloid leukemia, myelodysplastic syndrome, or concurrent sickle cell disease.\n2. Symptomatic CNS metastases and\u002For leptomeningeal disease requiring immediate radiotherapy or steroid therapy.\n3. Major surgery or radiotherapy within 4 weeks prior to the first dose of study drug.\n4. History of interstitial lung disease, slowly progressive dyspnea with dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, multiple allergies, or peripheral arterial disease.\n5. Concurrent requirement for radiotherapy.\n6. Known hypersensitivity to any component of the study drug formulation.\n7. Pregnancy or lactation.\n8. Any other condition deemed by the investigator to compromise patient safety or study validity.","ALL","18 Years",{"count":46,"type":47},96,"ESTIMATED","INTERVENTIONAL",[50],"PHASE2","Evaluate the efficacy and safety of Trilaciclib for myeloprotection prior to chemotherapy in advanced cholangiocarcinoma or pancreatic cancer.",[53,54],"Biliary Tract Neoplasms","Pancreatic Neoplasms","NOT_YET_RECRUITING","2025-08-29",{"date":58,"type":59},"2025-09-08","ACTUAL",{"date":61,"type":47},"2025-09-01",{"date":63,"type":47},"2028-09-01",{"name":5,"class":6}]