[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rui-hua Xu, MD, PhD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":112},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,70,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100569927","phase-2-second-line-irinotecan-liposome-combination-regimen-for-irinotecan-treated-pancreatic-cancer-100569927",false,"NCT06700603","Second-line Irinotecan Liposome Combination Regimen for Irinotecan-treated Pancreatic Cancer","Phase II Clinical Study of Irinotecan Liposome Combined with 5-FU\u002FLV for the Patients with Advanced Pancreatic Cancer Who Failed to Receive Irinotecan-containing Regimens","Inclusion Criteria:\n\n* 1\\. patients are fully aware of the study, participate voluntarily and sign an informed consent form (ICF);\n* 2\\. aged ≥18 years and ≤75 years;\n* 3\\. histologically or cytologically confirmed as pancreatic ductal adenocarcinoma;\n* 4\\. patients with advanced or metastatic pancreatic adenocarcinoma who have failed prior irinotecan-containing regimens and have no more than 3 prior lines of therapy.\n* 5\\. patients with at least one measurable target lesion according to RECIST 1.1 criteria;\n* 6\\. Eastern Cooperative Oncology Group (ECOG) physical status score: 0-1;\n* 7\\. expected survival time ≥ 3 months;\n* 8\\. absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL, platelets ≥ 90 x 10\\^9\u002FL and hemoglobin ≥ 90 g\u002FL (not transfused with blood, blood products, or corrected with granulocyte colony-stimulating factor or other hematopoietic-stimulating factor in the 14 days prior to the laboratory test);\n* 9\\. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal; AST and ALT ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with hepatic invasion); total bilirubin ≤1.5 times the upper limit of normal (≤3 times the upper limit of normal for patients with hepatic invasion);\n* 10\\. Women of childbearing potential must have had a negative pregnancy test (serum) within 7 days prior to enrollment and be willing to use an appropriate method of contraception for the duration of the trial and for 6 months after the last administration of the test drug.\n\nExclusion Criteria:\n\n* 1\\. hypersensitivity to any investigational drug or its components;\n* 2\\. concomitant serious uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe renal impairment; (e.g., progressive infections, uncontrollable hypertension, diabetes mellitus, etc.)\n* 3\\. cardiac function and disease consistent with one of the following conditions\n\n  1. Long QTc syndrome or QTc interval \\> 480 ms;\n  2. Complete left bundle branch block, degree II or degree III atrioventricular block;\n  3. Severe, uncontrolled arrhythmia requiring pharmacologic therapy;\n  4. New York Society of Cardiology classification ≥ grade III; 2. cardiac ejection fraction (LVEF) less than 50%; 3. history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormality within 6 months prior to recruitment.\n* 4\\. active hepatitis B or C infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA greater than 1x103 copies\u002FmL; hepatitis C virus RNA greater than 1x103 copies\u002FmL);\n* 5\\. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);\n* 6\\. imaging confirmation of intestinal obstruction;\n* 7\\. previous or current concurrent other malignancies (except effectively controlled non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast\u002Fcervix, and other malignancies that have been effectively controlled without treatment within the past five years);\n* 8\\. pregnant and lactating women and patients of childbearing age who do not wish to use contraception;\n* 9\\. patients with other malignant tumors requiring treatment;\n* 10\\. history of pulmonary hemorrhage\u002Fcoughing up ≥ grade 2 (defined as at least 2.5 mL of bright red blood) within 1 month prior to the first dose;\n* 11\\. a history of arterial embolism, severe hemorrhage (other than hemorrhage due to surgery), or a predisposition to existing embolism or severe hemorrhage within 6 months prior to the first administration of the drug\n* 12\\. a combination of symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, and spinal cord compression\n* 13\\. use of strong inhibitors or inducers of CYP3A4, CYP2C8, and UGT1A1 within 14 days prior to receiving study drug therapy\n* 14\\. who have used other clinical trial medications within 1 month prior to the first dose;\n* 15\\. female patients who are pregnant or lactating, and subjects of childbearing age who refuse to accept contraceptive measures\n* 16\\. patients who are not suitable for participation in this study in the judgment of the investigator, .-","ALL","18 Years","75 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a prospective, single-arm, two-cohort phase II clinical study. It is expected to enroll 48 patients with advanced or metastatic pancreatic cancer who have failed prior treatment with irinotecan-containing regimens, including two cohorts: cohort 1 for patients who have progressed within 6 months of the end of adjuvant therapy for early pancreatic cancer with a prior irinotecan regimen or for patients with imaging-confirmed progression within 3 months of the end of first-line therapy for advanced patients, and cohort 2 for patients who have progressed after more than Cohort 2 was for patients who had progressed more than 6 months after adjuvant treatment with previous irinotecan regimen for early-stage pancreatic cancer or more than 3 months after the end of first-line treatment for advanced-stage patients. The study was conducted at the Cancer Prevention and Control Center of Sun Yat-sen University. The study consists of a screening period (within 28 days), a treatment period (until disease progression or intolerable toxicity occurs in patients), and a follow-up period (12 months, safety follow-up and PFS follow-up). Subjects signed informed consent and underwent baseline examinations during the screening period, and patients who met the inclusion exclusion criteria entered the treatment period, and all subjects perfected the relevant examinations specified in the protocol during the treatment to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study period. After the treatment period was completed, a follow-up period was entered.",[27],"Pancreatic Cancer",[29,30,31],"Irinotecan","pancreatic","Irinotecan liposome","NOT_YET_RECRUITING","2024-11-19",{"date":35,"type":36},"2024-11-22","ACTUAL",{"date":38,"type":21},"2024-11-20",{"date":40,"type":21},"2026-12-31",{"name":42,"class":43},"Rui-hua Xu, MD, PhD","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100554636","phase-3-liposomal-irinotecan-and-5-fu-as-second-line-therapy-for-patients-with-escc-100554636","NCT06501664","Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC","Liposomal Irinotecan and 5-FU Versus Irinotecan \u002F Irinotecan+5-fluorouracil as Second-line Therapy for Patients With Esophageal Squamous Cell Carcinoma: A Open-label, Randomized Study","Inclusion Criteria:\n\n* Age: 18-75 years old.\n* Unresectable esophageal squamous cell carcinoma confirmed by histopathology and\u002For cytology.\n* Failure or intolerance to first-line treatment.\n* At least one measurable lesion (according to RECIST v1.1).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 \\~ 1.\n* The expected survival time ≥3 months.\n* Subject has adequate biological parameters as demonstrated by the following: absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet count ≥100×10\\^9\u002FL, hemoglobin (Hgb) ≥90 g\u002FL.\n* Adequate hepatic function as evidenced by total bilirubin ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN, ≤5 x ULN if liver metastases are present. Documented serum albumin ≥ 3 g\u002FdL.\n* Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 x ULN or creatinine clearance ≥60 mL\u002Fmin.\n* Subjects agree to use contraception and are not pregnant or breastfeeding women.\n* Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.\n\nExclusion Criteria:\n\n* Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.\n* Received irinotecan\u002Firinotecan liposome based therapy in the first line.\n* Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.\n* Active HIV infection.\n* Combined with uncontrollable systemic diseases, such as unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, severe pericardial disease history and other cardiovascular diseases; uncontrolled hypertension(Defined as systolic blood pressure≥140 mmHg and\u002For diastolic blood pressure≥90 mmHg after treatment with standardized antihypertensive drugs), or history of critical hypertension, hypertensive encephalopathy; uncontrollable diabetes, etc.\n* Presence of severe gastrointestinal disease (including active bleeding, \\> grade 1 obstruction , \\> grade 1 diarrhea or gastrointestinal perforation)\n* Allergy to or intolerance to therapeutic drugs or their excipients.\n* Presence of central nervous system metastasis.\n* Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.\n* Participated in other trial within 30 days or within 5 half-lives of the drug prior to the first dose of study treatment.\n* Patients who are not suitable to participate in this trial for any reason judged by the investigator.",{"count":52,"type":21},360,[54],"PHASE3","The aim of this study is to compare the efficacy and safety of liposome irinotecan +5-FU and irinotecan \u002F irinotecan +5-FU regimens in the second-line treatment of esophageal squamous cell carcinoma (ESCC).",[57],"Esophageal Cancer",[59,60,61],"liposomal irinotecan","second-line therapy","esophageal squamous cell carcinoma","2024-07-09",{"date":64,"type":36},"2024-07-15",{"date":66,"type":21},"2024-08-01",{"date":68,"type":21},"2027-11-30",{"name":42,"class":43},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100553562","phase-2-a-phase-lbli-clinical-study-in-advanced-or-metastatic-esophageal-squamous-cell-carcinoma-100553562","NCT06487702","A Phase lb\u002FlI Clinical Study in Advanced or Metastatic Esophageal Squamous Cell Carcinoma","Fruquintinib Combined With AK104 and Tegafur Gimeracial and Oteracil as Second-ine or After Line Treatment in Advanced or Metastatic ESCC","Inclusion Criteria:\n\n1. age:18-75 years old, Male or female patients\n2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (including the gastroesophageal junction), (Adenosquamous carcinoma with squamous cell carcinoma components-based is allowed to be included)\n3. Irretrievably resected, local advanced, relapsed or metastatic esophageal squamous cell carcinoma\n4. Previously received platinum-based systemic anti-tumor first-line therapy; Or received Neoadjuvant, adjuvant therapy, or radical chemoradiotherapy for ESCC, but disease recurrence or progression within 6 months after completion of treatment; no restrictions on prior immunotherapy treatment choice.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1\n6. At least one measurable lesion (RECIST1.1)\n7. Life expectancy of more than 3 months;\n8. Women of childbearing age were required to have had a negative pregnancy test (serum or urine) within 14 days before enrollment and to voluntarily use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug.For men, either surgical sterilization or consent to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug was given\n9. Have fully understood and voluntarily sign the ICF for this study;\n10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;\n11. Adequate hepatic, renal, heart, and hematologic functions\n\nExclusion Criteria:\n\n1. Have had other malignancies within the past 5 years, except for curatively treated radical skin basal cell or squamous cell carcinoma, Or cervical carcinoma in situ;\n2. Have received major surgical procedures (such as craniotomy, thoracotomy, or laparotomy) within 4 weeks before enrollment or are excepted to uddergo major surgery during the study treatment; received laparoscopic exploration within 2 weeks before enrollment; received central venous catheterization within 7 days prior to enrollment\n3. Have received chemotherapy, targeted therapy, traditional Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukins, etc.) within the first 4 weeks prior to enrollment, or are still within 5 half-lives of such medications\n4. Have symptomatic central nervous system metastases (with stable brain metastases confirmed by imageology for more than 3 months were eligible)\n5. Severe infection ((≥CTCAE grade 2 infection) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications;Baseline chest imaging suggested active pulmonary inflammation with clinically relevant symptoms or signs;the presence of signs and symptoms of infection within 2 weeks before the first dose of the study drug ,or the need for treatment with oral or intravenous antibiotics was excluded if prophylactic antibiotics were used;\n6. Previous and current presence of interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severely impaired pulmonary function may interfere with the detection and management of suspected drug-related pulmonary toxicity in subjects;Subjects with radiation pneumonitis within 6 months\n7. Had active pulmonary tuberculosis by medical history or CT examination, or who had a history of active pulmonary tuberculosis within 1 year before enrollment ,or who had a history of active pulmonary tuberculosis more than 1 year before enrollment but had not received regular treatment\n8. Congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU\u002Fml), hepatitis C (hepatitis C antibody positive, and HCV-RNA above the detection limit of the assay) or co-infection with hepatitis B and C;\n9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n10. With thrombotic diseases or receiving anticoagulant drugs;\n11. Patients at risk of gastrointestinal hemorrhage or obstruction;\n12. Unable to swallow the experimental drug;\n13. Patients who have previously experienced immune-related myocarditis, pneumonitis, colitis, hepatitis, nephritis, etc.were judged to be at greater risk for immunotherapy retreatment by the investigator;\n14. Patients with complications who require long-term use of immunosuppressive drugs or those who need systemic or local administration of corticosteroids with immunosuppressive effects\n15. Patients considered unsuitable for inclusion in this study by the investigator",{"count":78,"type":21},70,[24],"This is a prospective, single-arm, open-label，multi-center, phase Ib\u002FII study, aiming to evaluate the efficacy and safety of Fruquintinib combined With Cadonilimab (AK104) and Tegafur，Gimeracil and Oteracil Potassium in patients with locally advanced or metastatic esophageal squamous cell carcinoma after the failure of first-line treatments.",[82],"Esophageal Squamous Cell Carcinoma","2024-06-27",{"date":85,"type":36},"2024-07-05",{"date":87,"type":21},"2024-07-10",{"date":89,"type":21},"2027-06-10",{"name":42,"class":43},1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":91},"100541444","phase-2-a-phase-ii-study-of-surufatinib-combined-with-camrelizumab-and-mfolfox6-as-second-line-treatment-for-advanced-prad-100541444","NCT06329947","A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD","Inclusion Criteria:\n\n1. Have full understanding of this study and voluntarily sign the informed consent form;\n2. Male and Female aged between 18 and 75 years are eligible;\n3. Histologically or cytologically confirmed metastatic pancreatic cancer;\n4. Patients who have previously failed first-line gemcitabine-based chemotherapy or have disease progression\u002Frecurrence during previous neoadjuvant\u002Fadjuvant treatment or within 6 months after the end of treatment are considered to have failed first-line systemic chemotherapy; neoadjuvant\u002Fadjuvant treatment plan Also gemcitabine-based chemotherapy;\n5. Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n7. Predicted survival ≥12 weeks;\n8. Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Participated in other anti-tumor drug clinical trials within 28 days;\n2. Have previously received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or acted on T cell costimulation or checkpoints Treatment with any other antibodies of the pathway (such as OX40, CD137, etc.);\n3. Have previously received anti-vascular endothelial growth factor\u002Fvascular endothelial growth factor receptor (VEGF\u002FVEGFR) targeted drug treatment;\n4. Those who are known to be allergic to any of the drugs in the study;\n5. Brain metastasis accompanied by symptoms or symptom control time \\\u003C2 months;\n6. The subject has suffered from other malignant tumors in the past or at the same time within 5 years (except cured basal cell carcinoma of the skin and cervical cancer in situ);\n7. Insufficient bone marrow hematopoietic function (without blood transfusion within 14 days):\n\n   1. Absolute neutrophil count (ANC) \\\u003C1.5×109\u002FL;\n   2. Platelets \\\u003C100×109\u002FL;\n   3. Hemoglobin \\\u003C8g\u002FdL.\n8. Liver abnormalities:\n\n   1. When there is no liver metastasis, ALT, AST or ALP\\>2.5×the upper limit of the normal reference range (ULN); when there is liver metastasis, ALT, AST or ALP\\>5×ULN;\n   2. Serum total bilirubin \\>1.5×ULN (Gilber syndrome \\>3×ULN);\n   3. Decompensated cirrhosis (Child-Pugh liver function grade B or C);\n   4. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA copy number ≥2000IU\u002FmL (those who are HBsAg positive and hepatitis B virus DNA copy number \\\u003C2000IU\u002FmL need to receive at least 2 weeks of anti-HBV treatment before taking the first dose) ;\n   5. Hepatitis C virus (HCV) antibody positive and HCVRNA test positive.\n9. Kidney abnormalities:\n\n   1. Serum creatinine\\>1.5×ULN;\n   2. Routine urine test shows urine protein ≥++, and the 24-hour urine protein quantification is confirmed to be \\>1.0g;\n   3. Renal failure requiring hemodialysis or peritoneal dialysis;\n   4. Past history of nephrotic syndrome.；",{"count":99,"type":21},37,[24],"To preliminarily evaluate whether there is a survival benefit of surufatinib combined with camrelizumab and mFOLFOX6 as the second-line treatment for advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer",[103],"Advanced Pancreatic Cancer","2024-05-06",{"date":106,"type":36},"2024-05-08",{"date":108,"type":21},"2024-05-22",{"date":110,"type":21},"2026-09-30",{"name":42,"class":43},""]