[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-disease":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100637483","phase-1-dual-target-car-nk-cells-targeting-mesothelin-msln-and-muc1-in-advanced-pancreatic-ductal-adenocarcinoma-100637483",false,"NCT07627711","Dual-Target CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma","A Phase 1\u002F2, Open-label, Biomarker-guided, Dose-escalation and Expansion Study of Dual-targeting CAR-NK Cells Directed Against Mesothelin (MSLN) and MUC1, With an Exploratory CLDN18.2\u002FMUC1 Dual-target Cohort, in Patients With Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","DUAL-NK-PDAC","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).\n* Unresectable locally advanced or metastatic disease with progression after at least 1 prior standard systemic therapy regimen, or intolerance\u002Fineligibility for standard therapy.\n* At least 1 measurable lesion per RECIST v1.1.\n* Tumor antigen expression by central IHC (archival or fresh biopsy): • Arm A eligibility: MSLN positive and\u002For MUC1 positive. • Arm B eligibility: CLDN18.2 positive and\u002For MUC1 positive. (Example threshold: IHC 2+ or 3+ staining in \\>=50% of tumor cells, or H-score above protocol-defined cutoff.)\n* ECOG performance status 0-1.\n* Adequate organ function (example): ANC \\>= 1.0 x 10\\^9\u002FL; platelets \\>= 75 x 10\\^9\u002FL; hemoglobin \\>= 8 g\u002FdL; AST\u002FALT \\\u003C= 3x ULN (\\\u003C= 5x ULN with liver metastases); total bilirubin \\\u003C= 1.5x ULN; creatinine clearance \\>= 50 mL\u002Fmin.\n* Life expectancy \\>= 12 weeks.\n* Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined follow-up period.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Active or untreated CNS metastases or carcinomatous meningitis.\n* Clinically significant uncontrolled infection (including uncontrolled bacterial, fungal, or viral infection).\n* Known active hepatitis B or hepatitis C with detectable viral load; known uncontrolled HIV infection.\n* Prior allogeneic hematopoietic stem cell transplant or solid organ transplant.\n* Prior gene-modified cellular therapy (e.g., CAR-T\u002FCAR-NK) within 6 months or prior therapy targeting the same antigen(s) Ongoing requirement for systemic immunosuppressive therapy (e.g., chronic corticosteroids above physiologic replacement).\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, or NYHA class III\u002FIV heart failure) within a protocol-defined period.\n* Active autoimmune disease requiring systemic treatment in the past 2 years (replacement therapy allowed).\n* Pregnant or breastfeeding.\n* Any medical, psychiatric, or social condition that, in the investigator's opinion, would interfere with safe participation or interpretation of results.","ALL","18 Years","75 Years",{"count":21,"type":22},42,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This example study evaluates the safety, tolerability, and preliminary anti-tumor activity of investigational, dual-targeting chimeric antigen receptor natural killer (CAR-NK) cell products for patients with advanced pancreatic ductal adenocarcinoma (PDAC). Participants are assigned to one of two biomarker-defined cohorts based on tumor antigen expression: (A) Mesothelin (MSLN) and\u002For MUC1, or (B) Claudin 18.2 (CLDN18.2) and\u002For MUC1. The study uses a dose-escalation followed by dose-expansion design to define a recommended Phase 2 dose (RP2D) and to estimate response rates in each cohort.",[29,30,31],"Pancreatic Ductal Adenocarcinoma (PDAC)","Unresectable Locally Advanced","Metastatic Disease",[33,34,35,36,37,38,39,40,41,42,43,44],"Pancreatic cancer","PDAC","CAR-NK","Natural killer cells","Mesothelin","MSLN","MUC1","Claudin 18.2","CLDN18.2","Adoptive cell therapy","Immunotherapy","Biomarker-guided","RECRUITING","2026-05-31",{"date":48,"type":49},"2026-06-04","ACTUAL",{"date":51,"type":49},"2026-03-02",{"date":53,"type":22},"2028-03-17",{"name":55,"class":56},"Beijing Biotech","INDUSTRY",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":23,"phases":68,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":57},"100581922","phase-2-oligo-10-stereotactic-ablative-radiation-therapy-for-metastatic-patients-with-6-to-10-metastatic-sites-100581922","NCT06856603","OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients With 6 to 10 Metastatic Sites","OLIGO-10: Stereotactic Ablative Radiation Therapy for Metastatic Patients (6-10 Metastases): A Prospective Phase II Single-Arm Trial","OLIGO-10","Inclusion Criteria:\n\n* ECOG status 0-3\n* Persistent or progressive cancer disease with 6 to 10 metastases\n* ≤ 5 metastases in one organ\n* Life expectancy \\> 6 months for intracranial lesions\n* Inability to surgically resect all metastatic lesions\n* Positive tumor board decision for trial inclusion\n* Signed informed consent\n\nExclusion Criteria:\n\n* ECOG status 4\n* De novo metastatic disease\n* Radiological complete response after drug therapy\n* Brain metastasis only\n* Brain metastasis \\> 3 cm, requiring neurosurgery\n* Size of any metastasis \\> 5 cm\n* Previous radiation therapy for any metastatic site\n* Leptomeningeal, pleural, or peritoneal carcinomatosis\n* Spinal cord compression, requiring neurosurgery\n* Invasion of great vessels, skin, or GI tract\n* Negative tumor board decision for trial inclusion\n* Unsigned informed consent",{"count":67,"type":22},50,[26],"Currently, the standard of care for patients with diagnosed metastatic cancer is drug therapy (chemotherapy, targeted therapy, or immunotherapy). However, the approach to oligometastatic disease (1-5 metastases) is evolving. An increasing number of de novo, persistent, and progressive oligometastatic tumors are now being treated with curative intent, with radiation therapy among the most effective treatment options, applied to metastatic sites in ablative doses. Emerging results from the SABR-COMET 3 and 5 trials, which investigate stereotactic ablative radiotherapy for patients with 1-3 and 1-5 metastatic sites, demonstrate a clear improvement in overall survival. However, patients with more than five metastases remain in a gray area.\n\nThe aim of our study is to assess the safety and effectiveness of radiation treatment for patients with tumors of various localizations and 6 to 10 metastases in the bones and internal organs. Stereotactic radiation therapy will be applied to patients with persistent or progressive metastatic forms of tumors, without changing their ongoing drug therapy regimen.",[31],[31,72,73,74,75],"Stereotactic radiation therapy","Stereotactic body radiation therapy","Stereotactic ablative radiation therapy","Oligometastatic Disease","2025-02-28",{"date":78,"type":49},"2025-03-04",{"date":80,"type":49},"2025-02-07",{"date":82,"type":22},"2030-12-31",{"name":84,"class":85},"National Medical Research Radiological Centre of the Ministry of Health of Russia","OTHER"]