[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intrathecal-drug-delivery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intrathecal-drug-delivery":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100646266","intrathecal-therapy-versus-standard-care-for-severe-cancer-pain-100646266",false,"NCT07691840","Intrathecal Therapy Versus Standard Care for Severe Cancer Pain","Intrathecal Drug Delivery Systems Versus Comprehensive Medical Management for Severe Cancer Pain: a Randomized Controlled Trial","CAREGIVER","Inclusion Criteria:\n\n* Adult patients (≥18 years) with severe cancer refractory pain (all types of cancer), who have been receiving treatment with oral\u002Fsystemic opioids for at least 4 weeks, and are expected to remain on opioids for the entire duration of the study. More than one opioid rotation has to be done before defining pain refractoriness.\n* Intrathecal therapy is recommended because of inefficacy or intolerance to strong systemic opioid treatment. Inefficacy is defined as mean daily visual analogue scale (VAS) pain intensity score at rest of ≥ 50 mm. Intolerance is defined as the occurrence of (S)AEs (even with dosage less than 200 mg\u002Fday of oral morphine equivalents) which prevents a further increase in the opioid dosage to obtain pain relief.\n* Patients suitable for IDD and with the ability to comply with the medical protocol and visits.\n* Survival prognosis of ≥ 6 months.\n\nExclusion Criteria:\n\n* Patients with active, severe infection.\n* Patients with known brain metastases.\n* Patients with high risk of hemorrhaging.\n* Patients with respiratory depression (for use of morphine).\n* Patients with severe respiratory compromise; baseline oxygen SpO2 \\\u003C 90%, chronic CO2 retention.\n* Patients with severe cardiac disease or risk of cardiotoxicity (for use of bupivacaine).\n* Patients with severe liver impairment or liver failure (for use of ropivacaine).\n* Patients with allergies for medication or IDD hardware.\n* Pregnant or lactating women.\n* Women who plan to become pregnant within 1 month after the study.","ALL","18 Years",{"count":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24],"NA","Approximately 66% of patients with advanced cancer experience pain, which is often inadequately controlled and associated with a decline in health-related quality of life (HRQoL). Conventional pharmacologic management, ranging from simple analgesics to strong opioids, is frequently limited by insufficient efficacy and systemic side effects. Intrathecal drug delivery (IDD) offers targeted, continuous medication infusion directly into the intrathecal space, allowing lower systemic doses and potentially reducing side effects while maintaining effective analgesia. The CAREGIVER study is a randomized, controlled trial designed to evaluate whether patients with severe refractory cancer pain receiving IDD experience a difference in HRQoL compared to those receiving conventional medical management (CMM) with oral pain medications.",[27,28,29],"Intrathecal Drug Delivery","Refractory Cancer Pain","Conventional Medical Management",[31,32,33,34,35],"Intrathecal pumps","Intrathecal drug delivery","Refractory cancer pain","Health-related quality of life","Neuromodulation","RECRUITING","2026-07-07",{"date":39,"type":40},"2026-07-09","ACTUAL",{"date":42,"type":21},"2026-07-01",{"date":44,"type":21},"2029-10-31",{"name":46,"class":47},"Universitair Ziekenhuis Brussel","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":48},"100578301","phase-1-intrathecal-pd-1vegf-bispecific-antibody-plus-pemetrexed-for-leptomeningeal-metastasis-100578301","NCT06809517","Intrathecal PD-1\u002FVEGF Bispecific Antibody Plus Pemetrexed for Leptomeningeal Metastasis","A Phase I\u002FII Clinical Study of Intrathecal Combination Therapy With the PD-1\u002FVEGF Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of solid tumors;Cerebrospinal fluid cytopathology is positive.\n2. Male or female aged between 21 and 75 years; Normal liver and kidney function; WBC≥4000\u002Fmm3, Plt≥100000\u002Fmm3.\n3. No history of severe nervous system disease; No severe dyscrasia.\n\nExclusion Criteria:\n\n1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.\n2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.\n3. Obvious bleeding tendency; Patients with hemorrhage (NCI-CTCAE v5.0 greater than grade 2), coagulation disorder, hypertensive crisis, and severe arterial thrombosis.\n4. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \\>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.\n5. The first month to treatment, as well as during induction and consolidation therapy, new drugs effective against leptomeningeal metastases were used, excluding those previously administered. These primarily included small molecule targeted therapies, such as EGFR-TKI\u002FALK-TKI drugs like Osimertinib and Lorlatinib.\n6. Patients with poor compliance or other reasons that were unsuitable for this study.","21 Years","75 Years",{"count":59,"type":21},34,[61,62],"PHASE1","PHASE2","Leptomeningeal metastasis, characterized by tumor cells infiltrating and proliferating in the subarachnoid space, represents a distinct pattern of central nervous system involvement and is a fatal complication of malignant tumors.\n\nThis phase I\u002FII study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal PD-1\u002FVEGF bispecific antibody plus pemetrexed in patients with leptomeningeal metastasis.",[65,27],"Leptomeningeal Metastasis",[67,68,69],"Leptomeningeal metastasis","PD-1\u002FVEGF Bispecific Antibody","Pemetrexed","2025-05-15",{"date":72,"type":40},"2025-05-20",{"date":74,"type":40},"2025-03-18",{"date":76,"type":21},"2026-05-01",{"name":78,"class":47},"Guangzhou Medical University"]