[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adrenal-cortical-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adrenal-cortical-cancer":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,62],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":45,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100568639","phase-2-ivonescimab-in-the-treatment-of-multiple-advanced-tumors-100568639",false,"NCT06683846","Ivonescimab in the Treatment of Multiple Advanced Tumors","Ivonescimab (PD-1\u002FVEGF Bispecpecial Antibody) in the Treatment of Multiple Advanced Tumors: a Multi-cohort, Multi-center, Single-arm Phase II Study","Inclusion Criteria:\n\n* Individuals able to understand and give written informed consent.\n* Histologically or cytologically confirmed cancer of one of the following types:\n\nPAGET's disease of scrotum with infiltrating sweat gland carcinoma Paraganglioma Pheochromocytom, Renal angiomyolipoma Malignant perivascular epithelioid cell tumor, Rhabdomyosarcom Other sarcoma rather than rhabdomyosarcom\n\n* Stage IV disease\n* Adequate performance status (ECOG 0-2)\n* Expected survival ≥ 3 months.\n* Measurable disease by CT or MRI, Or lesions with skin infiltration.\n* Adequate hematology without ongoing transfusional support (hemoglobin \\> 9 g\u002FdL, absolute neutrophil count (ANC) \\> 1,500 per mm\\^3, platelets \\> 100,000 per mm\\^3).\n* Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).\n* Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 \u002FPT≤1.5×ULN, aPTT≤1.5×ULN.\n* Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction is not permitted during this period.\n* Ability to comply with research visit schedules and other protocol requirements.\n\nExclusion Criteria:\n\n* With any severe and\u002For uncontrolled disease. Including: (1)Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); (2) poor control of diabetes (fasting blood sugar \\[FBG\\] \\>10mmol\u002FL);\n\n  ≥2 grade myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥2 grade congestive heart failure (NYHA classification); (3)active or uncontrolled severe infections requiring systemic antibacterial, antifungal, or antiviral treatment (≥CTCAE 2-level infection), including tuberculosis infection; A history of active tuberculosis; (4)Uncontrolled ascites, pleural effusion, or pericardial effusion that require repeated drainage;\n* With active hepatitis (transaminase levels not meeting inclusion criteria; HBV reference: HBV DNA≥2000 IU\u002Fml or ≥10\\^4 copies\u002Fml; HCV reference: HCV RNA≥2000 IU\u002Fml or ≥10\\^4 copies\u002Fml; after nucleoside analog antiviral therapy below the above standard, can be included; chronic hepatitis B virus carrier, HBV DNA\\\u003C10\\^4 IU\u002Fml, must be treated with antiviral drugs during the trial period to be eligible for enrollment);\n* History of immunodeficiency, including HIV positive or subjects with other acquired or congenital immunodeficiency diseases;\n* Active autoimmune disease requiring systemic treatment within the past two years, or subjects with an autoimmune disease that the investigator judges may recur or is planned for treatment; except: non-systemic treatment of skin diseases (e.g. vitiligo, alopecia, psoriasis or eczema); autoimmune thyroiditis-induced hypothyroidism requiring stable dose replacement therapy with hormones; 13. Subjects who have experienced severe hypersensitivity reactions after using monoclonal antibodies; individuals who are known to be allergic to the active ingredients or excipients of the study drug;\n* Have participated or are currently participating in another clinical study within the past 4 weeks prior to study entry;\n* Received a live vaccine within the past 30 days prior to the first dose or plan to receive a live vaccine during the study;\n* History of severe allergies;\n* At risk of bleeding, or with impaired coagulation function, or currently receiving thrombolytic therapy;\n* History of substance abuse with an inability to abstain or a history of mental illness;\n* Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study, or who, in the opinion of the investigator, have other reasons not to be enrolled; Subjects who have a history of a clearly defined neurological or psychiatric disorder, such as dementia, epilepsy, or a history of seizure susceptibility;\n* Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study (such as severe diabetes, thyroid disorders, and mental illness), or who have a serious and\u002For unstable medical, psychological, or other condition (including laboratory abnormalities) that would affect the subject's safety or the subject's ability to provide informed consent, or who have any condition that would affect the study protocol and follow-up plan, including psychological, familial, social, or geographic factors;","ALL","18 Years",{"count":19,"type":20},400,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to learn if Ivonescimab works to treat advanced rare tumors including cohort 1: PAGET's disease of scrotum with infiltrating sweat gland carcinoma. cohort 2: Metastatic paraganglioma and pheochromocytoma. cohort 3: Metastatic renal angiomyolipoma and malignant perivascular epithelioid cell tumor.\n\ncohort 4: Rhabdomyosarcoma and Ewing's sarcoma cohort 5: Collecting duct carcinoma cohort 6: Urachal carcinoma. cohort 7: Neuroendocrine cancer. cohort 8: Basal cell carcinoma and sarcomatoid carcinoma. cohort 9: Penile cancer. cohort 10: Adrenal cortical cancer. cohort 11: Metastatic germ cell tumors, failure of standard cisplatin based therapy (mostly testicular cancer).\n\ncohort 12: Non-clear cell renal carcinoma (including renal papillary renal carcinoma); Renal cancer cannot be classified).\n\ncohort 13: Non-clear cell renal carcinoma (including chromophobe renal carcinoma) cohort 14: Other rare tumors that cannot be classified (such as testicular reticulum adenocarcinoma, etc.).\n\ncohort 15: Prostate cancer. cohort 16: Clear cell renal carcinoma. (16.1: received PD-1; 16.2: no PD-1 received) cohort 17: Urothelial carcinoma. cohort 18: Kidney cancer with brain metastases. cohort 19: Brain metastases of urothelial carcinoma. cohort 20: Rare tumors with brain metastases.\n\nIt will also learn about the safety of Ivonescimab. The main questions it aims to answer are:\n\nDoes Ivonescimab improve the objective response rate and prolong the survival of participants? What medical problems do participants have when taking Ivonescimab?\n\nParticipants will:\n\nReceive Ivonescimab 20mg\u002Fkg intravenously every 21 days until disease progression, intolerable toxicity, or full 2 years of treatment, whichever occurs first.\n\nBe performed imaging evaluation according to RECIST 1.1 every 9 weeks for 1 year of treatment and every 12 weeks after 1 year Be recorded any adverse events in the whole study period including type, incidence, grade, severity, duration, and association with the study drug according to NCI-CTCAE V5.0 criteria",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Pheochromocytoma\u002FParaganglioma","Rhabdomyosarcoma","Paget Disease, Extramammary","Renal Angiomyolipoma","Perivascular Epithelioid Cell Tumor, Malignant","Sarcoma","Urachal Cancer","Neuroendocrine Cancer","Basal Cell Carcinomas","Sarcomatoid Carcinoma","Penile Cancer","Adrenal Cortical Cancer","Germ Cell Cancer Metastatic","Non-Clear Cell Renal Cell Carcinoma","Prostate Cancers","Clear Cell Renal Cancer","Urothelial Carcinoma","Kidney Cancer","Rare Tumors",[46,47,48],"rare tumor","Ivocizumab","immunotherapy","RECRUITING","2025-08-19",{"date":52,"type":53},"2025-08-24","ACTUAL",{"date":55,"type":53},"2024-11-20",{"date":57,"type":20},"2027-11-30",{"name":59,"class":60},"Fudan University","OTHER",1,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":61},"100579967","phase-2-phase-ii-study-of-pd-1-inhibitor-combined-with-apatinib-and-mitotane-in-the-treatment-of-advanced-adrenal-cortical-carcinoma-100579967","NCT06831175","Phase II Study of PD-1 Inhibitor Combined With Apatinib and Mitotane in the Treatment of Advanced Adrenal Cortical Carcinoma","Inclusion Criteria:\n\n1. Histopathological diagnosis of adrenocortical carcinoma;\n2. Patients with unresectable advanced adrenocortical carcinoma who have not received first-line standard treatment;\n3. Age ≥18 years old, ≤70 years old;\n4. No gender limit;\n5. Eastern Cooperative Oncology Group (ECOG) score 0-1;\n6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1);\n7. Major organ function within 28 days before treatment, meeting the following criteria:\n\n   \\- Blood routine test criteria (without blood transfusion within 14 days) : Hemoglobin (HB) ≥80g\u002FL Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL Platelet (PLT) ≥80×10\\^9\u002FL\n\n   \\- Biochemical tests must meet the following criteria: Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN or ≤5 ULN if liver metastases are present Serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr)≥60 ml\u002Fmin\n\n   \\- Coagulation testing requires the following criteria: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 ULN Activated partial thromboplastin time (APTT) ≤1.5 ULN (if the patient is anticoagulated, as long as the PT and APTT are within the intended therapeutic range)\n\n   \\- Cardiac markers and natriuretic peptide (BNP) ≤ULN;\n8. Women of childbearing age should agree that they must use a contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study and for 120 days after the study; Patients had a negative serum or urine pregnancy test within 7 days before study entry and had to be non-lactating; Men should consent to patients who must use contraception during the study and for 6 months after the end of the study period;\n9. Study participants provided written informed consent and were willing and able to follow planned visits, study treatments, laboratory tests, and other experimental procedures.\n\nExclusion Criteria:\n\n1. A history of other malignant tumors within the past 5 years or at the same time, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and thyroid papillary carcinoma;\n2. Known allergic reactions to other monoclonal antibodies, active ingredient of mitotane, active ingredient of apatinib and or any excipients;\n3. CNS metastases with clinical symptoms such as brain edema, requiring hormonal intervention, or progression of brain metastases;\n4. Patients who received potent CYP3A4 inhibitor treatment within one week before enrollment or a potent CYP3A4 inducer treatment within two weeks before the first use of study drug;\n5. Patients with hypertension not well controlled by antihypertensive drug therapy alone (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg);\n6. NYHA class III-IV congestive heart failure;\n7. Occurrence of arterial\u002Fvenous thrombosis events within 1 year before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), myocardial infarction, unstable angina pectoris, deep vein thrombosis, and pulmonary embolism;\n8. QT interval \\> 500 ms;\n9. Prior systemic immunosuppressive therapy;\n10. Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies;\n11. TKI treatment within 2 weeks before the first dose;\n12. Participating in other interventional drug clinical trials within 4 weeks before the first dose;\n13. Received an antineoplastic vaccine or a live vaccine within 4 weeks before the first dose of study drug;\n14. Major surgery or major trauma within 4 weeks before the first dose of study medication;\n15. Had a serious infection (CTCAE \\> 2) within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; The presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first dose of the study drug, or the need for treatment with oral or intravenous antibiotics (excluding prophylactic antibiotics) on baseline chest imaging.\n16. Have an active autoimmune disease, a history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); Autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type 1 diabetes on stable doses of insulin; However, patients with vitiligo or childhood asthma\u002Fallergies that had been cured and did not need any intervention in adulthood were excluded.\n17. Have a history of immunodeficiency, including being HIV positive or having other acquired or congenital immunodeficiency disorders, or having a history of organ or bone marrow transplantation;\n18. A history of non-infectious pneumonia;\n19. Active pulmonary tuberculosis infection detected by medical history or CT examination, or a history of active pulmonary tuberculosis infection within 1 year before enrollment or patients who had a history of active pulmonary tuberculosis infection 1 year ago but had not received formal treatment;\n20. Subjects with active hepatitis (HBV DNA≥2000 IU\u002Fml or 10000 copies\u002Fml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the assay);\n21. A known history of psychotropic drug abuse, alcohol abuse, and drug use;\n22. Have GI bleeding symptoms and risk of bleeding;\n23. Are pregnant or lactating;\n24. Have medical history, disease, treatment, or laboratory abnormalities that may interfere with the results of the trial or prevent the subject from participating fully in the study, or the investigator believes that participation in the study is not in the subject's best interest.","70 Years",{"count":70,"type":20},28,[23],"Adrenocortical carcinoma (ACC) is a rare aggressive malignant tumor. According to the literature, the 5-year survival rate of ACC is 12%-47%. For patients with advanced ACC, mitotane alone or combined with traditional chemotherapy was the first-line standard treatment, but its progression-free survival was only about 1 year. The efficacy of mitotane monotherapy is approximately 10% to 30%. FIRM-ACT trial reported an objective response rate (ORR) of 23.2% for etoposide, doxorubicin, cisplatin, and mitotane (EDP-M) chemotherapy regimen. Our phase II study found that PD-1 inhibitor camrelizumab and apatinib showed impressive clinical data in the second-line treatment of relapsed and metastatic ACC patients. The aim of this study is to evaluate the efficacy and safety of PD-1 inhibitor camrelizumab combined with apatinib and mitotane in advanced ACC, and to explore a new treatment strategy for patients with advanced ACC.",[74,37,75],"Adrenal Cortical Carcinoma","Adrenal Cancer",[77,78,79,80],"Camrelizumab","Mitotane","Apatinib","Advanced Adrenal Cortical Carcinoma","2025-06-01",{"date":83,"type":53},"2025-06-03",{"date":85,"type":53},"2025-03-15",{"date":87,"type":20},"2031-12-31",{"name":89,"class":60},"West China Hospital"]