[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatic-metastasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatic-metastasis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100441388","phase-2-magnetic-resonance-guided-adaptive-stereotactic-body-radiotherapy-for-hepatic-metastases-100441388",false,"NCT05027711","Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases","Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases - MAESTRO -","MAESTRO","Inclusion Criteria:\n\n* confirmed underlying solid malignant tumor (no germ cell tumor, leukemia, lymphoma)\n* 1-3 hepatic metastases confirmed by pre-therapeutic MRI\n* indication for SBRT of 1-3 hepatic metastases\n* maximum diameter each hepatic metastasis ≤ 5 cm (in case of 3 metastases: sum of diameters ≤ 12 cm)\n* age ≥ 18 years of age\n* Karnofsky Performance Score ≥ 60%\n* ability to lie still on the radiotherapy treatment couch for at least one hour\n* ability to hold one's breath for more than 25 seconds\n* for women with childbearing potential, adequate contraception\n* ability of subject to understand character and individual consequences of the clinical trial\n* written informed consent (must be available before enrolment in the trial)\n\nExclusion Criteria:\n\n* refusal of the patients to take part in the study\n* patients with primary liver cancer (eg. HCC, CCC)\n* patients after liver transplantation\n* impairment of liver function to an extent contraindicating radiotherapy (to the discretion of the treating radiation oncologist)\n* active acute hepatic\u002Fbiliary infection (e.g. hepatitis, cholangitis, cholecystitis)\n* previous radiotherapy of the hepatobiliary system, if previous and current target volumes overlap MAESTRO Study Studienprotokoll Seite 25 von 54 Version 1.0 vom 17.12.2020\n* patients who have not yet recovered from acute toxicities of prior therapies\n* claustrophobia\n* pregnant or lactating women\n* contraindications against performing contrast-enhanced MRI scans (pacemakers, other implants making MRI impossible, allergy to gadolinium (GD)-based contrast agent)\n* participation in another competing clinical study or observation period of competing trials","ALL","18 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Stereotactic body radiotherapy (SBRT) is an established local treatment method for patients with hepatic oligometastases. Liver metastases often occur in close proximity to radiosensitive organs at risk (OARs). This limits the possibility to apply sufficiently high doses needed for optimal local control. MR-guided radiotherapy (MRgRT) is expected to hold potential to improve hepatic SBRT by offering superior soft-tissue contrast for enhanced target identification as well as the benefit of daily real-time adaptive treatment. The MAESTRO trial therefore aims to assess the potential advantages of adaptive, gated MR-guided SBRT (MRgSBRT) compared to conventional SBRT at a standard linac using an ITV (internal target volume) approach (ITV-SBRT).",[27],"Hepatic Metastasis",[29],"Magentic Resonance-guided Adaptive Stereotactic Body Radiotherapy","RECRUITING","2026-03-06",{"date":33,"type":34},"2026-03-10","ACTUAL",{"date":36,"type":34},"2021-08-12",{"date":38,"type":21},"2030-01-31",{"name":40,"class":41},"University Hospital Heidelberg","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100467069","phase-1-study-to-assess-the-safety-and-preliminary-efficacy-of-sti-1386-oncolytic-virus-in-relapsed-or-refractory-solid-tumors-100467069","NCT05361954","Study to Assess the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Relapsed or Refractory Solid Tumors","A Phase 1b, Dose-Escalation Study of the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Patients With Relapsed or Refractory Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed extracranial solid tumors that are relapsing or refractory including locally advanced pancreatic cancer, unresectable soft tissue sarcomas, hepatic metastases due to colorectal cancer\n* At least one measurable disease per Response Evaluation Criteria in Solid Tumors v. 1.1 (RECIST 1.1) with a non-nodal lesion with longest diameter ≥ 10 mm or nodal lesions with short diameter ≥ 15 mm\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2\n* As assessed by the investigator, ≥ 3 month life expectancy\n* Adequate hematologic, liver and renal function at Screening as determined by lab criteria\n* Recovered \\\u003C Grade 2 from all acute toxicities from previous therapy\n* Has not had prior treatment with high dose corticosteroids within the 2 weeks of screening\n* Is willing and able to comply with the study schedule and other protocol requirements\n* Willing to follow contraception guidelines\n\nExclusion Criteria:\n\n* Have a primary brain tumor\n* Use of an investigational drug or local therapy or agent within 2 weeks of first dose of study drug. Current systemic chemotherapy per investigator's discretion is allowed, but no immune checkpoint inhibitors or immune modulators\n* Use of anticoagulants or anti-platelet agents unless subject can safely start\u002Fstop to allow intratumoral injections\n* Use of bevacizumab (Avastin) within 28 days of the STI-1386 injection\n* Diagnosis of other malignancies that have required therapy in the last year or are not in complete remission. Exceptions include non-metastatic basal cell or squamous cell carcinomas of the skin, prostate cancer or cancer in situ that does not require treatment currently or is otherwise under control\n* Requiring chronic systemic immunosuppressants, including steroids \\> 20 mg\u002Fday\n* Presence of bulky disease defined as any single mass \\> 5 cm in greatest dimension will trigger a discussion to determine eligibility\n* New York Heart Association (NYHA) Class \\>3 of left ventricular ejection fraction (LVEF) \\\u003C 50%\n* Prolonged corrected QT interval as determined by 12-lead electrocardiogram\n* Has spinal cord compression or clinically unstable brain metastases within 4 weeks of first dose of study drug\n* Evidence of active herpes infection and\u002For chronic herpes infection requiring prophylactic antiviral medication that may not be discontinued\n* Has an active or recent COVID-19 infection, must have a negative RT-PCR test and not have had symptoms within 4 weeks of day 1 of study drug administration\n* Any active infection requiring systemic therapy within 72 hours of injection of STI-1386, excluding anti-viral maintenance therapy for HIV\n* Moderate to severe chronic obstructive pulmonary disease or other moderate to severe chronic respiratory conditions unless under treatment and stable for the 3 months of screening\n* Have active human immunodeficiency virus (HIV) infection, human T-cell leukemia virus type 1 (HTLV1) infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia\n* Pregnant or lactating or up to 3 months post last dose\n* Underlying medical conditions that, in the opinion of the investigator and\u002For medical monitor will prevent the subject from participating\n* Allergy to acyclovir and related anti-HSV antiviral agents",{"count":51,"type":21},36,[53],"PHASE1","This is a Phase 1b study to assess the safety and tolerability of STI-1386, an oncolytic virus, in subjects with relapsed and refractory solid tumors (RRSTs).",[56,57,58,27,59],"Cancer","Cancer of Pancreas","Sarcoma","Solid Tumor",[56,61,62],"solid tumor","hepatic metastasis","NOT_YET_RECRUITING","2023-04-10",{"date":66,"type":34},"2023-04-12",{"date":68,"type":21},"2023-08",{"date":70,"type":21},"2027-02",{"name":72,"class":73},"Sorrento Therapeutics, Inc.","INDUSTRY"]