[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrence-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrence-tumor":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,78,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100613196","phase-2-efficacy-of-the-combination-of-trimipramine-and-atezolizumab-with-bevacizumab-in-patients-with-recurrent-glioblastoma-a-phase-2-trial-100613196",false,"NCT07263438","Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma: a Phase 2 Trial","Open-label Phase II Clinical Trial to Test the Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma","Phenix","Inclusion Criteria:\n\n* Histologically or cytologically confirmed glioblastoma, according to World Health Organization \\[WHO\\] 2021 with unequivocal first progression after standard (6 weeks radiotherapy \\[RT\\]) with concurrent \\& adjuvant temozolomide \\[TMZ\\] chemotherapy.\n* Patients must be at least 3 months off the concomitant part of chemo-radiotherapy.\n* Stable or decreasing dose of steroids for 7 days prior to the baseline\n* Magnetic Resonance Imaging \\[MRI\\] scan.\n* Maximum dose of dexamethasone (or equivalent) 4 mg at time of inclusion.\n* No surgery or other invasive procedures (major surgical procedure, open biopsy or significant traumatic injury) within 4 weeks prior to registration.\n* No core biopsy or other minor surgical procedure within 7 days prior to registration. (Placement of a central vascular access device, if performed at least 2 days prior to trial treatment administration, is allowed).\n* Patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs \\[non-EIAED\\]. Patients previously on EIAED must be switched to non-EIAED at least 2 weeks prior to registration.\n* Measurable disease per Response Assessment in Neuro-Oncology \\[RANO\\] version 2.0 criteria. Recurrent disease must be at least one bi-dimensionally measurable contrast-enhancing lesion with clearly defined margins by MRI scan, with minimal diameters of 10 mm, visible on 2 or more axial slices 5 mm apart, based on MRI scan done within 28 days prior to registration.\n* Karnofsky performance status 70-100.\n* Adequate bone marrow function: neutrophil count ≥ 1.5 x 10\\^9\u002FL, platelet count ≥ 100 x 109\u002FL, hemoglobin ≥ 90 g\u002FL.\n* Adequate hepatic function: total bilirubin ≤ 1.5 x Upper Limit of Normal \\[ULN\\] (except for patients with Gilbert's syndrome ≤ 3.0 x ULN), aspartate aminotransferase \\[AST\\] and alanine transaminase \\[ALT\\] and alkaline phosphatase \\[AP\\] ≤ 2.5 x ULN.\n* Adequate renal function: estimated glomerular filtration rate \\[eGFR\\] ≥ 45 mL\u002Fmin\u002F1.73 m2 (according to Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula).\n* Urine dipstick for proteinuria \\\u003C 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hours urine collection and must demonstrate ≤ 1 g of protein\u002F24 hours.\n* Adequate coagulation function: International Normalized Ratio \\[INR\\] ≤ 1.5 x ULN (the ULN for INR is defined with the value 1.2 for all sites, in case no ULN is documented in the laboratory certificates\u002Fsheets). Use of full-dose anticoagulants is permitted as long as the INR is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks before registration, as per American Society for Clinical Oncology \\[ASCO\\] guidelines, low molecular weight heparin \\[LMWH\\] should be the preferred approach. Concomitant anticoagulation with aspirin (up to 300 mg\u002Fday) and anticoagulation with LMWH is allowed.\n* Women of childbearing potential must use highly effective contraception , are not pregnant or breast-feeding and agree not to become pregnant during trial treatment and until 6 months after the last dose of investigational drug. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential.\n* Men agree not to donate sperm or to father a child during trial treatment and until 6 months after the last dose of investigational drug.\n* Patient is able and willing to swallow trial drug as whole tablet.\n\nOnly for Cohort 2:\n\n* Consent to giving access of part of the tumor tissue and Cerebrospinal Fluid \\[CSF\\] obtained during the routine neurosurgical procedure for pharmacology and translational studies. Tumor tissue will only be made available once it is established that enough tumor tissue is available for standard neuropathological analysis.\n* Patients that have a medical indication for a neurosurgical resection from first recurrent tumor.\n\nExclusion Criteria:\n\n* Patient must be in first progression\u002Frecurrence and have not received more than one line of chemotherapy (concurrent and adjuvant temozolomide). Treatment of Time to Treatment Failure \\[TTF\\] fields (Optune®) is allowed during first line but will be stopped at registration.\n* Patients must not have prostate enlargement with urinary retention or angle-closure glaucoma at registration.\n* Any other experimental drug must be discontinued at least 30 days prior to registration\n* Patients under ongoing treatment with an antidepressant must be eligible for a switch to trimipramine. Patients currently under TriCyclic Antidepressant \\[TCAs\\] (amitriptyline, clomipramine, nortriptyline, imipramine), selective serotonin reuptake inhibitors (sertraline, paroxetine, fluvoxamine, citalopram, escitalopram) or serotonin and norepinephrine reuptake inhibitors (venlafaxine, duloxetine) must be weaned off these medications for at least 14 days before the introduction of trimipramine.\n\nNote: Patients treated with fluoxetine prior to enrollment will only be eligible for this trial after a two-month washout period before starting the study treatment.\n\n* Prior treatment with atezolizumab or any other immune checkpoint inhibitors.\n* Prior treatment with bevacizumab or other Vascular Endothelial Growth Factor \\[VEGF\\] inhibitors or VEGF-receptor signaling inhibitors.\n* Concomitant or prior use of immunosuppressive medication within 5 half-lives before registration, with the exceptions of intranasal and inhaled corticosteroids.\n* Life expectancy of less than 12 weeks.\n* Active systemic prior malignancy. Patients with a prior malignancy (basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix) and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration.\n* Blood pressure combination treatment with more than two antihypertensive medications or uncontrolled blood hypertension under properly antihypertensive medications.\n* Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association \\[NYHA\\] III or IV; unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).\n* Have a heart rate corrected QT interval using Fridericia's formula \\[QTcF\\] (QTc = QT \u002F RR\\^1\u002F3) ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalaemia, familial history of long QT interval syndrome). Patients with bundle branch block and prolonged QTcF are permitted with approval of the sponsor investigator.\n* Presence of a grade 3 atrioventricular \\[AV\\] block on electrocardiogram \\[ECG\\].\n* History of cerebrovascular accident or intracranial haemorrhage within 6 months prior to registration.\n* Known history of human immunodeficiency virus \\[HIV\\] or active chronic hepatitis C or hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antimicrobial treatment.\n* Known history of tuberculosis, known history of primary immunodeficiency, known history of allogeneic organ transplant. Receipt of live attenuated vaccine within 28 days prior to the first dose of atezolizumab administration. Vaccination with inactivated viruses, such as those in the influenza vaccine, are permitted.\n* History of or active auto-immune disease with the exception of diabetes mellitus type II and well controlled hypothyroidism on treatment.\n* Concomitant treatment with strong or moderate cytochrome P450 3A or 2D6 \\[CYP3A or CYP2D6\\] inducers or inhibitors.\n* Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information.\n* Monoamine oxidase inhibitors \\[MAOI\\] (Rasagiline, or others not approved in Switzerland, such as phenelzine, tranylcypromine, isocarboxazid and selegiline). Of note, MAOI must have been stopped at least 14 days prior to the start of trimipramine.\n* Known hypersensitivity to trial drug(s) or to any component of the trial drug(s)\n* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient","ALL","18 Years",{"count":20,"type":21},59,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicentric phase II open-label clinical trial aiming to assess the efficacy of the combination of trimipramine and atezolizumab with bevacizumab in patients with recurrent glioblastoma. Eligible patients will be assigned to two cohorts depending on whether there is a medical indication for a neurosurgical resection from first recurrent tumor or not.\n\nThe aim of the cohort 1 (patients without indication for surgery) is to analyze the clinical efficacy of this triple combination in recurrent glioblastoma. 48 patients will be registered.\n\nThe aim of cohort 2 (patients with indication for surgery) is to confirm the level of trimipramine that can be achieved in the tumor tissue and cerebrospinal fluid collected during surgery. At least 5 patients will be registered.\n\nAll patients will receive the combination treatment (trimipramine and atezolizumab associated with bevacizumab) for a maximum period of 2 years from registration. The treatment schedule is slightly different for the 2 cohorts because of the neurosurgical resection foreseen for cohort 2 and the requirement to start bevacizumab only after the surgery. After the end of treatment, all patients will be followed up for safety during 90 days from first treatment administration and then up to 3 years from registration.",[27,28],"Glioblastoma","Recurrence Tumor",[30,31,32,33],"recurrent glioblastoma","trimipramine","atezolizumab","bevacizumab","RECRUITING","2026-02-11",{"date":37,"type":38},"2026-02-13","ACTUAL",{"date":40,"type":38},"2025-11-03",{"date":42,"type":21},"2030-12-31",{"name":44,"class":45},"Centre Hospitalier Universitaire Vaudois","OTHER",7,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100336312","phase-1-immunotherapy-for-the-treatment-of-advanced-solid-tumor-100336312","NCT03658785","Immunotherapy for the Treatment of Advanced Solid Tumor","Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen for the Treatment of Advanced Solid Tumor","Inclusion Criteria:\n\nTo be eligible for the study, patients must meet ALL of the following criteria prior to enrollment in the study:\n\n1. Must be ≥ 18 years of age at the time of consent.\n2. Must have recurrent, metastatic, or persistent carcinoma that is not amenable to curative treatment with surgery and\u002For radiation therapy and for which no other therapies are expected to have significant benefit, in the opinion of the Investigator.\n3. Must have at least 1 lesion that is resectable for TIL generation. The resected TIL generating lesion(s) should yield at least 1.5 cm in diameter post-resection of tumor tissue. Following resection for TIL generation, must have a remaining measurable target lesion as defined by RECIST v1.1.\n4. Patients must have progressive disease while receiving or after the completion of the most recent prior treatment.\n5. Any prior therapy directed at the malignant tumor must be discontinued at least 28 days prior to tumor resection. Radiation therapy may have been received up to 28 days prior to tumor resection for lesions not expected to be used for TIL generation or target lesions.\n6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Patients must be seronegative for the human immunodeficiency virus (HIV).\n8. Patients with positive serology for hepatitis B virus surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), or hepatitis C virus (anti-HCV) indicating acute or chronic infection may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with\u002Fwithout active treatment.\n9. Hematology:\n\n   Absolute neutrophil count greater than 1000\u002Fmm(3) without the support of filgrastim;White blood cell (WBC) greater than or equal to 3000\u002Fmm(3);Platelet count greater than or equal too 100,000\u002Fmm(3);Hemoglobin greater than 8.0 g\u002Fdl.\n10. Chemistry:\n\n    Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) less than or equal to to 2.5 times the upper limit of normal. Serum creatinine less than or equal to to 1.6 mg\u002Fdl.Total bilirubin less that or equal to 1.5 mg\u002Fdl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg\u002Fdl.\n11. Women of child bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.\n\nExclusion Criteria:\n\n1. Patients who have received an organ allograft or prior cell transfer therapy.\n2. Patients who are on a systemic steroid therapy \\> 10 mg of prednisone daily or other steroid equivalent.\n3. Patients who currently have prior therapy-related toxicities greater than Grade 1 according to NCI-CTCAE v4.03; except for peripheral neuropathy, alopecia, or vitiligo prior to enrollment\u002Fresection.\n4. Patients who have a contraindication to or history of hypersensitivity reaction to any component or excipients of the TIL therapy and the other study drugs.\n5. Patients with active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory, or immune system.\n6. Patients with symptomatic and\u002For untreated brain metastases (of any size and any number).\n7. Patients who have any form of primary or acquired immunodeficiency syndrome, such as severe combined immunodeficiency disease or acquired immune deficiency syndrome (AIDS).\n8. Patients who have a diagnosis of end-stage renal disorder requiring hemodialysis.\n9. Patients who have a left ventricular ejection fraction (LVEF) \\\u003C 45% or who are New York Heart Association (NYHA) Class 2 or higher.\n\n   Patients who have a forced expiratory volume in 1 second (FEV1) of less than or equal to 60% of predicted normal.\n10. Patients who have received a live or attenuated vaccine within 28 days of the NMA-LD regimen.\n11. Patients whose cancer requires immediate treatment or who would otherwise suffer a disadvantage by participating in this study.","70 Years",{"count":56,"type":21},40,[58,24],"PHASE1","The purpose of this study is to evaluate the safety, side effects and benefits of autologous tumor infiltrating lymphocytes (TIL) specific to personalized Neo-antigens in the treatment of patients with recurrent, metastatic and advanced solid tumors.",[28,61,62],"Metastatic Cancer","Solid Tumor",[64,65,66,67],"TIL","neo-antigen","Cyclophosphamide","Fludarabine","2024-08-11",{"date":70,"type":38},"2024-08-13",{"date":72,"type":38},"2020-04-28",{"date":74,"type":21},"2025-12-31",{"name":76,"class":45},"Tongji Hospital",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":77},"100400868","hepatopredict-prognostic-tool-for-the-decision-of-liver-transplant-in-hepatocellular-carcinoma-100400868","NCT04499833","HepatoPredict Prognostic Tool for the Decision of Liver Transplant in Hepatocellular Carcinoma","Evaluation of the HepatoPredict Prognostic Tool in the Decision of Liver Transplant in Hepatocellular Carcinoma","HepatoPredict","Inclusion Criteria:\n\n* Hepatocellular carcinoma associated with cirrhosis\n* Ages between 18 and 70 years\n* Total tumour volume below 500 cm3\n* Total number of tumour lesions below 10\n* Maximum individual tumour diameter below 10 cm\n\nExclusion Criteria:\n\n* eligible under the \"Milan Criteria\"",{"count":56,"type":21},[88],"NA","Liver transplant is the most effective treatment for hepatocellular carcinoma (HCC) in cirrhosis. Due to organs shortage, the proper selection of patients is imperative. Prevailing clinical morphological models used in most centres (Milan Criteria), can exclude potential candidates and include patients with aggressive biological behaviour. To more accurately select candidates for liver transplant, the inclusion of criteria that could predict the behaviour and aggressiveness of tumours, such as molecular markers, might be useful.\n\nThe investigators propose the use of a new algorithm (HepatoPredict Prognostic Tool), that combine clinical and molecular criteria that address the biology of tumours, in a single centre prospective, intervention study. Data from the \"HepatoPredict genomic signature\" are added to the clinical and imagiology algorithm. Based on this tool, patients outside the usual eligibility criteria for liver transplant will be proposed for this treatment. These patients will be transplanted with marginal livers or with livers from patients with Familial Amyloid Polyneuropathy, not competing with patients on the waiting list. Patients will be followed up to 60 months after transplant, to assess survival and HCC recurrence with biannual imagiology screening. Survival and disease-free-survival rates will be compared with those obtained by the usual management of patients included and excluded by Milan Criteria.",[91,28],"Hepatocellular Carcinoma, Scirrhous",[93,94,95,96,97,98],"cirrhosis","Hepatocellular Carcinoma","liver transplant","tumor recurrence","biomarkers","prognosis","2022-06-03",{"date":101,"type":38},"2022-06-06",{"date":103,"type":38},"2021-03-25",{"date":105,"type":21},"2029-12-31",{"name":107,"class":45},"Centro Hospitalar de Lisboa Central",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":117,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100366589","hepatocarcinoma-recurrence-on-the-liver-study---part2-100366589","NCT04053231","Hepatocarcinoma Recurrence on the Liver Study - Part2","HERCOLES2","Inclusion Criteria:\n\n* No age limit.\n* Hepatocarcinoma diagnosis confirmed at histological specimen\n* Every single patients with first HCC diagnosis or with a recurrence\u002Fpersistence disease evaluated and treated with surgery at the participating center.\n* the assessment for patient enrollment must have been performed starting from 02\u002F02\u002F2019.\n\nExclusion Criteria:\n\n* Surgery as a downstaging therapy for transplant\n* Patients treated with surgery in case of not-curative intent (palliation, best supportive care, etc).\n* Histopathological specimen of combined liver primary neoplasms (e.g. \"hepatocholangiocarcinoma'').\n* Patients with other tumors in the previous past.",{"count":116,"type":21},3000,"15 Years","OBSERVATIONAL","Rationale for the trial. To evaluate the impact of surgery on hepatocarcinoma recurrence. Thus, to evaluate the impact of different clinical, radiological, histopathological variables on recurrence after surgical treatment. The nature of this study will allow to observe, over time, the distribution of the considered collection variables, allowing a strictly observational monitoring of possible associations able to suggest models or interpretations, which can then be the basis for the construction of prospective and randomized studies.",[121,122,28,123],"Liver Cancer","Surgery","Cirrhosis",[125,126,127,128,129,130,93],"liver","hcc","hepatocarcinoma","surgery","redo surgery","recurrence","NOT_YET_RECRUITING","2019-08-09",{"date":134,"type":38},"2019-08-12",{"date":136,"type":21},"2019-09",{"date":138,"type":21},"2034-05",{"name":140,"class":45},"University of Milano Bicocca",19]