[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"M.R. Meijerink\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100638460","phase-1-ct-guided-percutaneous-radionuclide-therapy-with-32p-microparticles-in-patients-with-non-progressive-locally-advanced-pancreatic-cancer-100638460",false,"NCT07595835","CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer","Safety and Feasibility of CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer (PANCOSIL): an Open-label, Single-arm Phase 1-2 Feasibility Study","PANCOSIL","Inclusion Criteria:\n\n* Age ≥18 years\n* Locally advanced pancreatic cancer, defined by the DPCG consensus criteria as: arterial involvement \\>90 degrees or venous involvement \\>270 degrees.\n* At least RECIST stable disease after a minimum two months of chemotherapy according to current clinical practice\\*\n* Capable of providing written and oral informed consent\n* Candidate for RNT, judged by a multidisciplinary tumor board\n* WHO 0-2\n\nExclusion Criteria:\n\n* Eligibility for resection\n* Participation in other trials focussing on different ablative treatment modalities such as radiofrequency ablation or irreversible electroporation for LAPC\n* Known hypersensitivity to silicon or phosphor\n* Bleeding disorders which cannot be corrected with medication\n* Inability\u002Funwillingness to interrupt anticoagulation therapy\n* Pregnancy\n* Metastatic pancreatic cancer\n* Epilepsy episode(s) in the past six months\n* Longest tumor diameter \\>70 mm or total target tumor volume \\>110 ml\n* Presence of multiple collateral vessels surrounding or adjacent to the target tumor on radiologic imagining, prohibiting safe injection of the OncosilTM device\n* Presence (or significant risk) of varices near the target tumor on radiologic imaging\n* Recent clinically significant pancreatitis\n* Previous administration of radiotherapy to the pancreas","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Pancreatic ductal adenocarcinoma is a highly lethal cancer, and approximately 40% of patients present with non-metastatic locally advanced pancreatic cancer (LAPC) that is not suitable for surgical resection. To improve outcomes in this patient group, local ablative treatments are being explored. Radionuclide therapy (RNT) is a promising option that delivers high-dose internal radiation directly into the tumor, potentially achieving better local tumor control while sparing surrounding tissues compared with external-beam radiation therapy. The OncoSil™ device is a type of RNT containing Phosphorus-32-radiolabeled microparticles. The ³²P microparticles have been designed to deliver a localized distribution of beta-radiation within the target tumor up to 100 Gy, which causes direct damage to cancer cell DNA and renders them incapable of further cell division and proliferation. Favorable results have been reported by implanting ³²P microparticles intra-tumorally, which is typically administered via endoscopic ultrasound guidance. A percutaneous approach may allow for more precise and reproducible delivery, but prospective data on its safety and feasibility are lacking.\n\nThis prospective, single-arm phase 1-2 feasibility study aims to evaluate the safety and feasibility of percutaneous CT- guided RNT using ³²P microparticles in patients with non-progressive LAPC following induction chemotherapy. Twenty adult patients with pathology-confirmed LAPC, showing non-progressive disease according to RECIST, will be included after multidisciplinary tumor board review. Patients will undergo percutaneous, CT-guided implantation of ³²P microparticles under general anesthesia, sedation, or local analgesia depending on study phase and clinical judgment, followed by continuation of standard systemic chemotherapy and routine follow-up.\n\nThe primary endpoint is the rate of adverse events (CTCAE grade ≥3) occurring during the procedure and within 90 days afterward. Secondary endpoints include technical success, all adverse events, best overall respons, overall and progression-free survival, and changes in tumor markers.",[28],"Pancreatic Cancer",[30,31,32,33,34,35,36],"radionucleide therapy","brachytherapy","P32","internal radiotherapy","LAPC","³²P microparticles","Oncosil","RECRUITING","2026-05-19",{"date":40,"type":41},"2026-05-22","ACTUAL",{"date":43,"type":41},"2023-06-04",{"date":45,"type":21},"2026-06-01",{"name":47,"class":48},"M.R. Meijerink","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":49},"100564549","phase-1-dose-finding-efficacy-and-immunological-response-of-ip-001-following-mwa-or-ire-for-crlm-100564549","NCT06630624","Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM","INJECTABL-II: Dose Finding, Efficacy and Immunological Response of a Novel Immuno-Adjuvant (IP-001) Following Microwave Ablation or Irreversible Electroporation for Colorectal Liver Metastases.","INJECTABL-II","All phases:\n\nInclusion Criteria:\n\n* Measurable metastatic CRC based on RECIST v1.1;\n* The primary tumor has been resected before study inclusion or the patient is asymptomatic with respect to the in situ primary tumor;\n* Last imaging ≤ 4 weeks prior to the on-study ablative procedure;\n* Age ≥ 18 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status of no more than 1;\n* A life expectancy of at least 3 months at the time of inclusion;\n* Adequate bone marrow, liver, and renal function as assessed by laboratory tests. These results should be judged by the local investigator and should be conducted within 7 days prior to definite inclusion;\n* Written informed consent.\n\nExclusion Criteria:\n\n* Compromised liver function defined as warning signs of portal hypertension, INR \\> 1,5 without use of anticoagulants, bilirubin \\> x 1.5 Upper limit of normal range (ULN) ASAT \\>5.0 x ULN, ALAT \\>5.0 x ULN.\n* Compromised kidney function defined as eGFR \\<45 ml\u002Fmin (using the Cockcroft Gault formula);\n* Active autoimmune disease requiring disease-modifying therapy at the time of screening or during the study period: i.e. \\> 10 mg prednisolone per day or other immunosuppressive therapy (e.g. methotrexate);\n* Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results;\n* Known allergic reaction to shellfish, crabs, crustaceans, or any trial components;\n* Known history of HIV or active Hepatitis C or Hepatitis B infection;\n* Uncontrolled infections (\\> grade 2 NCI-CTC version 3.0); requiring antibiotics;\n* Pregnant or breast-feeding subjects; Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment;\n* Known allergy to contrast agent that cannot be adequately prevented;\n* Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study;\n* Major surgery or radiotherapy ≤ 3 weeks (7 days for single fraction of palliative radiotherapy) prior to the on-study ablative procedure;\n* Systemic therapy ≤ 4 weeks prior to the on-study ablative procedure;\n* CTCAE Grade ≥1 from all side effects of prior therapies or prior procedures at the time of inclusion.\n\nPhase 1\n\nInclusion Criteria:\n\n* Progressive or stable metastatic CRC on CT-scan after at least 1 lines of standard of care systemic treatment. Standard of care systemic treatment will be defined and determined by the treating oncologist. A summary of standard of care systemic treatment for CRLM as used by the medical oncologists at Amsterdam UMC has been listed in Table 1. Patients can also be included if systemic treatment has to be terminated due to toxicity or when patients refuse (further) systemic treatment, or when patients are in a therapy break from systemic therapy as patients can continue with further systemic treatment one month after the study treatment;\n* At least 2 CRLM eligible for MWA with a minimum diameter of 1cm and a maximum diameter of 3cm and one (optional but not required) CRLM that will be left untreated and is eligible for biopsy;\n* No limitations on intrahepatic or extrahepatic disease;\n\nExclusion Criteria:\n\n\\- No additional exclusion criteria.\n\nPhase 2 part 1:\n\nInclusion Criteria:\n\n* At least one CRLM and a maximum of three CRLM size ≤ 3 cm eligible for MWA with curative intent;\n* Additional unablatable CRLM should be resectable with a maximum of 10 additional CRLM;\n* Resectability and ablatability should be re-confirmed intra-operatively by US in case of combined\u002Fstaged resection and ablation. Intra-operatively also full exploration for hepatic, peritoneal and regional lymph node metastases should be performed;\n\nExclusion Criteria:\n\n* Radical treatment unfeasible or unsafe (e.g. insufficient FLR);\n* The presence of extrahepatic nodal or non-nodal metastases. One locally treatable lung metastasis is allowed;\n* Any surgical resection or focal ablative liver therapy for CRLM prior to inclusion;\n\nPhase 2 part 2:\n\nInclusion Criteria:\n\n* Liver only or liver dominant measurable metastatic CRC based on RECIST v1.1;\n* Liver dominant metastatic disease is defined as the hepatic tumorload (number and estimated volume) exceeding the extrahepatic tumorload, with a maximum of 5 unequivocal extrahepatic metastases in ≤2 different organ systems;\n* At least 2 CRLM, of which at least one is eligible for the study treatment (RFA, MWA and IRE);\n* At least 50% (number and estimated volume) of the CRLM should be eligible for ablation. A maximum of 4 CRLM can be assigned for the study treatment. One CRLM has to be left untreated;\n* At least one untreated CRLM and one 'to-be-treated' CRLM should be eligible for biopsy;\n* Maximum size of CRLM for study treatment is 3cm;\n* Any CRLM with a maximum lesion size of 5cm at time of inclusion;\n* Limited extrahepatic disease, restricted to the lungs and lymph nodes, with a maximum lesion size of 3cm at time of inclusion. See below for additional information regarding pulmonary nodules;\n* Progressive disease on CT-scan after standard of care systemic treatment. Standard of care systemic treatment will be defined and determined by the treating oncologist. Patients can also be included if systemic treatment has to be terminated due to toxicity or when patients refuse (further) systemic treatment.;\n\nExclusion Criteria:\n\n* Tumor diameter of ≥ 5 cm of any hepatic lesion at the time of inclusion. If lesion size exceeds 5 cm at start of the procedure, the patient will not be excluded;\n* Metastases in the lungs or lymph nodes ≥ 3 cm. If lesion size exceeds 3 cm at start of the procedure, the patient will not be excluded;\n* Metastases in any other organ than the liver, lungs of lymph nodes;",{"count":59,"type":21},120,[24,25],"The primary objectives of this phase I\u002FII, prospective clinical trial, are to assess the optimal dose, efficacy, safety and immunological effect of ablation and intra-tumoral injection of a novel immuno-adjuvant (IP-001) for colorectal liver metastases (CRLM). The study consists of three parts, devided into two phases.\n\nPhase 1 is a dose-escalation study according to a classic '3+3' design, to identify the dose level at which IP-001 exhibits an acceptable level of toxicity following microwave ablation (MWA) of CRLM in refractory metastatic colorectal cancer (CRC) patients.\n\nPhase 2, part 1 and part 2 are performed simultaneously. In phase 2 part 1, a single arm study assesses the efficacy of IP-001 following MWA for CRLM for curative intent. In phase 2 part 2, a randomized, two-armed study assesses the efficacy and immunomodulation of IP-001 following two ablative modalities: arm A (MWA) and arm C (irreversible electroporation (IRE)) for CRLM in refractory metastatic CRC patients.",[63,64,65],"Colorectal Cancer","Liver Metastases","Liver Metastasis Colon Cancer",[67,68,69,70,71],"Colorectal liver metastases","Colorectal hepatic metastases","irreversible electroporation","Microwave ablation","Immunotherapy","2025-06-30",{"date":74,"type":41},"2025-07-03",{"date":76,"type":41},"2024-07-10",{"date":78,"type":21},"2031-08-01",{"name":47,"class":48},""]