[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intratumoral-injection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intratumoral-injection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100503705","phase-1-study-of-rimo-301-and-radiotherapy-with-pd-1-inhibitor-for-the-treatment-of-head-neck-cancer-100503705",false,"NCT05838729","Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer","Phase 1b\u002F2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable, Recurrent or Metastatic Head-Neck Cancer","Inclusion Criteria:\n\n* Diagnosis of head-neck cancer that requires palliative radiotherapy\n* Patients with unresectable, recurrent or metastatic HNSCC, regardless if the patients have progressed on or are intolerant to platinum-based chemotherapy prior to study enrollment or if the patients are receiving pembrolizumab in the first line:\n\n  * receiving a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care, or\n  * suitable to receive a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care in the discretion of the treating physician or Principal Investigator\n* Must have at least 1 target lesion that is clinically accessible to RiMO-301 injection and amenable to receive RT regimens specified in this protocol\n* The selected target lesions must be measurable on cross-sectional imaging and repeated measurements at the same location should be achievable\n* Target tumor not in the previously irradiated field or in the field irradiated at least six months prior to RiMO-301 injection and with no complications from the prior radiation course\n* RiMO-301 injection to multiple lesions (≤ 5 in total) in a single patient is allowed as long as the total tumor volume does not exceed 250 cm3\n* Patient must have recovered from acute toxic effects (≤ grade 1 CTCAEv5) of previous cancer treatments prior to enrollment\n* Have adequate bone marrow reserve and adequate liver function\n* Have a life expectancy of at least 12 weeks\n* ECOG score of 0-2\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions\n* Symptomatic central nervous system metastases and\u002For carcinomatous meningitis\n* Active autoimmune disease that has required systemic treatment in the past 2 years\n* Ongoing clinically significant infection at or near the incident lesion\n* Major surgery over the target area (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤7 days. No waiting is required following implantable port, enteral feeding tube and catheter placement\n* Has received any approved or investigational anti-neoplastic agent or immunotherapy other than PD-1 inhibitors (pembrolizumab or nivolumab) within 4 weeks prior to RiMO-301 injection\n* Patients with lesions which have significant blood vessel involvement (such as carotid artery encasement) or other major structures","ALL","18 Years",{"count":19,"type":20},16,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with hypofractionated radiation and a PD-1 Inhibitor in patients with unresectable, recurrent or metastatic head-neck cancer.",[27,28],"Head Neck Cancer","Intratumoral Injection","RECRUITING","2025-09-11",{"date":32,"type":33},"2025-09-17","ACTUAL",{"date":35,"type":33},"2023-04-03",{"date":37,"type":20},"2026-12",{"name":39,"class":40},"Coordination Pharmaceuticals, Inc.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":41},"100549169","the-clinical-efficacy-and-safety-of-intratumoral-injection-of-chemotherapy-for-advanced-solid-tumors-100549169","NCT06430515","The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors","The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors Through Fine Needle Puncture","Inclusion Criteria:\n\n1. Male or female aged 18-75 years;\n2. Subjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy;\n3. Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);\n4. ECOG score of 0-2, lifespan \\> 12 weeks;\n5. Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;\n6. Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1. The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);\n2. White blood cell count ≥ 50×10\\^9\u002F L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;\n3. Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.\n4. HIV, HBV and HCV positive;\n5. Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;\n6. Patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months;\n7. Patients are on anticoagulation or have severe coagulopathy (APTT\\>70);\n8. Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;\n9. Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;\n10. Subjects in other conditions that are considered unsuitable for this study by the investigator.","85 Years",{"count":51,"type":20},200,[53],"NA","This project intends to investigate the clinical efficacy of intra-tumoural injection of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration guided by CT or ultrasound in patients with advanced solid cancers to validate the safety and efficacy.",[28,56],"Cancer","2024-05-24",{"date":59,"type":33},"2024-05-28",{"date":61,"type":33},"2023-09-01",{"date":63,"type":20},"2028-12-31",{"name":65,"class":66},"Wuxi People's Hospital","OTHER"]