[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Second Affiliated Hospital of Shandong First Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,39,58,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"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":18,"type":19},96,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","Evaluate the efficacy and safety of Trilaciclib for myeloprotection prior to chemotherapy in advanced cholangiocarcinoma or pancreatic cancer.",[25,26],"Biliary Tract Neoplasms","Pancreatic Neoplasms","NOT_YET_RECRUITING","2025-08-29",{"date":30,"type":31},"2025-09-08","ACTUAL",{"date":33,"type":19},"2025-09-01",{"date":35,"type":19},"2028-09-01",{"name":37,"class":38},"The Second Affiliated Hospital of Shandong First Medical University","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":20,"phases":47,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":55,"leadSponsor":57,"locationsCount":4},"100604504","phase-2-a-phase-ii-single-arm-study-of-iparomlimab-and-tuvonralimab-ql1706-in-combination-with-lenvatinib-and-tace-for-advanced-hepatocellular-carcinoma-100604504","NCT07150377","A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Lenvatinib and TACE for Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* First-line Cohort:\n\n  1. Confirmed diagnosis of hepatocellular carcinoma (HCC), aged \\> 18 years. No prior systemic therapy.\n  2. Child-Pugh class A\u002FB at baseline.\n  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.\n  4. Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).\n  5. Adequate organ and bone marrow function.\n\nSecond-line Cohort:\n\n1. Confirmed diagnosis of HCC, aged \\> 18 years.\n2. Prior first-line therapy (including targeted therapy or immunotherapy).\n3. Child-Pugh class A\u002FB at baseline.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.\n5. Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).\n6. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Concomitant hepatic encephalopathy.\n2. History of any nephrotic syndrome.\n3. History of clinically significant cardiovascular disease or arterial thromboembolic events, including stroke, myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization.\n4. Evidence of any prior or current coagulopathy or bleeding diathesis, or any type of surgery performed within the past 28 days (biopsy is not excluded).\n5. History of abdominal fistula, gastrointestinal perforation, refractory non-healing gastric ulcer, or active gastrointestinal bleeding within 6 months prior to randomization.\n6. Main portal vein thrombosis visible on baseline imaging.\n7. Pleural or peritoneal effusion requiring clinical intervention.\n8. Gastroesophageal varices.\n9. Portal vein invasion (VP3 or VP4).",{"count":46,"type":19},41,[22],"To evaluate the efficacy of Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular carcinoma by assessing Progression-Free Survival (PFS).",[50],"Hepatocellular Carcinoma (HCC)","2025-08-24",{"date":53,"type":31},"2025-09-02",{"date":51,"type":19},{"date":56,"type":19},"2028-08-24",{"name":37,"class":38},{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":20,"phases":67,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100601336","phase-2-the-safety-and-efficacy-of-benmelstobart-injection-in-patients-with-advanced-biliary-tract-malignant-tumors-100601336","NCT07109167","The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors","Inclusion Criteria\n\nAge: 18 to 75 years old, inclusive; of either sex. Histopathologically confirmed unresectable and previously untreated gallbladder cancer or intrahepatic\u002Fextrahepatic cholangiocarcinoma, with at least one measurable lesion per RECIST v1.1 criteria. Tissue samples must be provided for biomarker analysis, preferably recently obtained tissue. If recent tissue is unavailable, 5-8 archived 5μm-thick paraffin-embedded sections are acceptable.\n\nECOG performance status: 0 or 1. Life expectancy ≥12 weeks.\n\nNormal major organ function, defined as meeting the following criteria:\n\n1. Hematological tests:\n\n   1. Hemoglobin (HB) ≥90 g\u002FL (without blood transfusion within 14 days prior).\n   2. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL.\n   3. Platelet count (PLT) ≥80×10⁹\u002FL.\n2. Biochemical tests:\n\n   1. Albumin (ALB) ≥30 g\u002FL (without albumin transfusion within 14 days prior).\n   2. ALT and AST \\\u003C2.5×upper limit of normal (ULN); if liver metastases are present, ALT and AST ≤5×ULN.\n   3. Total bilirubin (TBIL) ≤1.5×ULN.\n   4. Plasma creatinine ≤1.5×ULN; or creatinine clearance (CCr) ≥60 ml\u002Fmin. Subject voluntarily agrees to participate, signs the informed consent form, and is able to comply with scheduled study visits and procedures.\n\nFemale subjects of childbearing potential or male subjects with partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after treatment completion.\n\nExclusion Criteria Confirmed allergy to any component of Benmelstobart Injection. Uncontrolled hypertension (systolic blood pressure \\>140 mmHg and diastolic blood pressure \\>90 mmHg), coronary heart disease of Grade I or higher, arrhythmia of Grade I or higher (including QTc interval prolongation: males \\>450 ms, females \\>470 ms), or heart failure of Grade I or higher; patients with positive urine protein.\n\nPatients with definite gastrointestinal bleeding tendency, including: active local ulcerative lesions with fecal occult blood test (++); history of melena or hematemesis within 2 months.\n\nCoagulopathy (INR \\>1.5, APTT \\>1.5×ULN) or bleeding tendency. Multiple factors affecting oral drug absorption (e.g., inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).\n\nPatients with central nervous system metastases. Pregnant or lactating women. Patients with other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).\n\nPatients with a history of psychotropic drug abuse who are unable to abstain or with mental disorders.\n\nPatients who participated in other drug clinical trials within 4 weeks. Patients with abnormal thyroid function. Urine protein ≥++ or 24-hour urine protein \\>1.0 g. Radiotherapy to target lesions within 4 weeks prior to the first dose of study treatment.\n\nUse of immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding nasal, inhaled, or other topical glucocorticoids or physiological doses of systemic glucocorticoids (i.e., ≤10 mg\u002Fday prednisone or equivalent dose of other glucocorticoids).\n\nAdministration of live attenuated vaccines within 4 weeks prior to the first dose of study treatment or planned during the study period.\n\nMajor surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or unhealed wounds, ulcers, or fractures.\n\nActive, known, or suspected autoimmune disease or history of such diseases within the past 2 years (patients with vitiligo, psoriasis, alopecia, or Graves' disease that did not require systemic treatment in the past 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type 1 diabetes requiring only insulin replacement therapy are eligible).\n\nUncontrolled concurrent diseases including but not limited to: HIV infection (HIV antibody positive); active or poorly controlled severe infections.\n\nSymptomatic congestive heart failure (New York Heart Association class II-IV) or symptomatic or poorly controlled arrhythmias.\n\nHistory of interstitial lung disease. Pregnant or lactating female patients. Known history of primary immunodeficiency. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.","75 Years",{"count":66,"type":19},30,[22],"Evaluate the progression-free survival (PFS) of benmelstobart combined with gemcitabine and cisplatin in first-line patients with advanced cholangiocarcinoma, and the progression-free survival (PFS) of benmelstobart combined with anlotinib in second-line patients with advanced cholangiocarcinoma.",[25],"2025-07-31",{"date":72,"type":31},"2025-08-07",{"date":74,"type":19},"2025-08-01",{"date":76,"type":19},"2027-08-01",{"name":37,"class":38},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":20,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100523178","phase-2-the-efficacy-and-safety-of-tas-102suyuan-combined-with-bevacizumab-as-first-line-therapy-in-patients-with-advanced-colorectal-cancer-100523178","NCT06092242","The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Life expectancy of at least 3 months\n3. Definitive histological or cytological evidence of adenocarcinoma of the colon or rectum;\n4. Patients who had not previously received first-line chemotherapy or targeted therapy for metastatic colorectal cancer, or who had received adjuvant chemotherapy after radical resection and had relapsed 12 months after completion of adjuvant chemotherapy;\n5. Patients who can not or can not tolerate combination chemotherapy.\n6. ECOG performance status was PS ≤2;\n7. According to RECIST Version 1.1, at least 1 measurable metastatic lesion was present;\n8. Appropriate organ function according to laboratory test values obtained within 7 days prior to administration of the study drug on Day 1 of Cycle 1.\n\n   A .The hemoglobin value was more than 90 g\u002FL. B. The absolute neutrophil count was \\> 1.500 MM3. C. Platelet count was \\> GT; 100,000\u002Fmm (\\> GT; 100 \\* 10 ° L) . D. Total serum bilirubin was 1.5 x upper limit of normal (ULN) . E.Don't L-aspartic Acid aminotransferase (asgot) and endolaminic aminotransferase (Alt SGPT)≤2.5 x upper limit of normal (ULN) , and AST and ALT ≤5 x ULN if abnormal liver function is due to basal liver metastasis.\n\n   F. Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance ≥50 ml\u002Fmin;.\n\n   G.Adequate coagulation: international standard ratio (INR) or prothrombin time (PT)≤1.5 times the upper limit of normal;. Urine or serum pregnancy tests were negative within 7 days of randomization.\n9. Women at risk of pregnancy must agree to use adequate contraception during the study until 6 months after the cessation of the study drug; Men had to agree to use adequate contraception during the study until six months after the study drug was discontinued.\n10. Willing and able to follow research protocols and visit plans.\n\nExclusion Criteria:\n\n1\\. The existence of serious diseases and serious medical conditions, this includes, but is not limited to, the following:\n\n1. the presence of other active malignancies at the same time, excluding those that have not been diagnosed for more than 5 years or are considered curable with adequate treatment,\n2. the known presence of brain or pial metastases,\n3. systemic active infection (ie, infection leading to body temperature ≥38 ° C-RRB- ,\n4. clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease,\n5. uncontrolled diabetes;\n6. patients who have experienced any arterial thrombosis, embolism, or ischemic or hemorrhagic disease in the last 6 months and have not improved after appropriate treatment, such as unstable myocardial infarction, unstable angina, cerebrovascular accident after treatment,\n7. severe\u002Funstable angina, NYHA Class III or IV symptomatic congestive heart failure,\n8. clinically significant gastrointestinal bleeding,\n9. known presence of human immunodeficiency virus (HIV) or acquired conventional immunodeficiency syndrome (AIDS)-related disease, or active hepatitis B or C,\n10. presence of psychiatric disorders that may increase the risk of participating in the study or taking research drugs, or that may interfere with the interpretation of the study results;\n11. patients with grade 2 or more hypertension before treatment who had not improved or were unstable with antihypertensive drugs,\n12. patients with nephrotic syndrome or with proteinuria ≥2 + or more before treatment who had not improved or were unstable after treatment, 13-RRB- patients with a history of gastrointestinal perforation in the last 6 months,\n13. patients with Hypertensive crisis hypertensive encephalopathy. 2.Any of the following treatments were performed within a specific time frame prior to study drug administration,\n\n1）major surgery (laparotomy, thoracotomy, and evisceration by laparoscopy) was performed within the previous 4 weeks. Switch surgery was not included) ; 2) had received extended-range radiotherapy within the previous 4 weeks or had received limited-range radiotherapy within the previous 2 weeks; 3) had received any investigational medication within the previous 4 weeks. 3. Neurotoxicity of CTCAE grade 2 or above that has not subsided as a result of adjuvant therapy, 4. A pregnant or lactating woman. 5. The researchers did not consider it appropriate to enter the study.","85 Years",{"count":86,"type":19},50,[22],"To evaluate the efficacy and safety of TAS-102 combined with bevacizumab as first-line therapy in patients with advanced colorectal cancer who could not tolerate or did not receive combined chemotherapy",[90],"Colorectal Cancer",[90],"2023-10-14",{"date":94,"type":31},"2023-10-23",{"date":96,"type":19},"2023-10-15",{"date":98,"type":19},"2027-10-15",{"name":37,"class":38},1,""]