[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Everfront Biotech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100619828","phase-2-comparison-of-cerebraca-wafer-plus-temozolomide-versus-temozolomide-alone-in-recurrent-glioblastoma-100619828",false,"NCT07349693","Comparison of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma","A Randomized Trial to Assess the Efficacy and Safety of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma","Cerebraca-02\u002F3","Inclusion Criteria, subjects must meet all following criteria for study enrollment:\n\n1. Subject must be aged ≥ 18, regardless of gender\n2. Subject must have histologically confirmed glioblastoma with:\n\n   1. Completed first-line therapy including surgery plus temozolomide and radiation (concurrent temozolomide\u002Fradiation)\n   2. Current presentation being first or second recurrence only\n3. Subject must have measurable disease preoperatively with at least one contrast-enhancing MRI-identified lesion measuring ≥ 1 cm in two perpendicular dimensions per RANO 2.0 criteria\n4. Subject must be deemed eligible for gross total resection of contrast-enhancing MRI-identified lesion by neurosurgeon's pre-operative assessment, according to RANO II\n5. Subject must have Karnofsky Performance Status (KPS) ≥ 70\n6. Subject must have recovered from prior therapy toxicities with adequate organ function:\n\n   1. Hemoglobin ≥ 8 g\u002FdL\n   2. Platelets ≥ 100,000\u002Fmm3\n   3. White blood cell count (WBC) ≥ 3,000 cells\u002Fmm3\n   4. Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n   5. Absolute lymphocyte count (ALC) ≥ 1,000 cells\u002Fmm3\n   6. Coagulation tests (prothrombin time \\[PT\\], activated partial thromboplastin time \\[APTT\\], International Normalized Ratio \\[INR\\]) ≤ 1.5 × ULN\n   7. Total bilirubin (TBIL) \\\u003C 3 × ULN\n   8. Alkaline phosphatase (ALP) ≤ 3 × ULN and\u002For Gamma glutamyltransferase (GGT) ≤ 1.5 × ULN\n   9. Aspartate aminotransferase (AST)\u002Fserum glutamic oxaloacetic transaminase (SGOT) and\u002For Alanine aminotransferase (ALT)\u002Fserum glutamic pyruvic transaminase (SGPT) ≤ 3 x ULN\n   10. eGFR ≥ 30 mL\u002Fmin (MDRD formula)\n   11. QTc interval: msec ≤ 450 (males) or 470 (females) (Fridericia's formula: QTc=QT\u002FRR(1\u002F3); RR=RR interval)\n\nExclusion Criteria, subjects with any of the following will be excluded:\n\n1. Histological confirmation of oligodendroglioma or mixed glioma\n2. Presence of IDH or H3K27M mutation, or 1p19q co-deletion\n3. MRI-identified lesion meeting any criteria:\n\n   1. Multi-focal (defined as 2 non-contiguous contrast enhancement areas \\> 1 cm in 2 planes on fluid-attenuated inversion recovery, FLAIR or T2-weighted sequences)\n   2. Presence of diffuse subependymal or leptomeningeal dissemination\n   3. Contrast-enhancing lesion \\> 6 cm in any dimension\n4. Tumor location unsuitable for surgical resection and Cerebraca Wafer implantation in the brain areas where surgical intervention would cause significant neurological deficits\n5. Prior bevacizumab treatment with uncontrollable tumor progression\n6. History of other malignancy within past 5 years\n7. Immunocompromised status or autoimmune conditions requiring systemic immunosuppressive therapy, with the following exceptions:\n\n   1. Patients with autoimmune conditions may be eligible after individual assessment of the condition, its severity, and potential interaction with the Cerebraca Wafer.\n   2. Patients with HIV infection are eligible if they:\n\n   i. Have CD4+ T-cell counts ≥350 cells\u002FμL ii. Are on stable anti-retroviral therapy iii. Have HIV viral load below the limit of quantification c. Patients with HBV infection are eligible if they: i. Are on appropriate suppressive anti-viral therapy prior to study enrollment ii. Have no evidence of hepatic decompensation d. Patients with history of HCV infection are eligible if they: i. Have completed curative anti-viral treatment with HCV viral load below the limit of quantification\n8. Active, uncontrolled infection or medical condition that could compromise safety and efficacy assessment","ALL","18 Years",{"count":20,"type":21},175,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This study is designed as a multi-center, randomized, open-label trial to evaluate the efficacy of Cerebraca Wafer in patients with recurrent glioblastoma. Cerebraca Wafer is intended for use in recurrent glioblastoma as an adjunct to surgery (followed by standard-of-care temozolomide), demonstrating potential to improve outcomes in this serious and life-threatening condition",[28],"Recurrent Glioblastoma, IDH-Wildtype","NOT_YET_RECRUITING","2026-01-15",{"date":32,"type":33},"2026-01-20","ACTUAL",{"date":35,"type":21},"2026-11-01",{"date":37,"type":21},"2030-12-01",{"name":39,"class":40},"Everfront Biotech Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100391756","phase-1-a-phase-iiia-study-of-ef-009-in-patients-with-pancreatic-cancer-100391756","NCT04381130","A Phase I\u002FIIa Study of EF-009 in Patients with Pancreatic Cancer","A Phase I\u002FIIa Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety and Efficacy Profile of EF-009 in Patients with Pancreatic Cancer","Inclusion Criteria:\n\n1. Female or male, age ≥ 18 years old\n2. Subject has cytological, histological, or pathological confirmation of pancreatic cancer Note: All histologic subtype(s) of exocrine and endocrine pancreatic cancer are eligible to enroll in the study\n3. Borderline resectable or unresectable pancreatic cancer judged by the PI in consultation with the designated site radiologist and surgeon at the treating institution Borderline resectable tumors are those that have:\n\n   1. no distant metastases;\n   2. venous involvement of the superior mesenteric vein (SMV)\u002Fportal vein (PV) with or without impingement and narrowing of the lumen;\n   3. short segment venous occlusion but with suitable vessel proximal and distal to occlusion, allowing for safe resection and reconstruction;\n   4. gastroduodenal artery (GDA) encasement up to the hepatic artery (HA) with either short segment encasement or direct abutment of HA, without extension to the celiac axis (CA); and\n   5. tumor abutment of the SMA not to exceed 180° of the circumference.\n\n   Unresectable tumors are those that have:\n   1. Arterial:\n\n      Head\u002Funcinate process:\n      * Solid tumor contact with SMA \\>180°\n      * Solid tumor contact with the CA \\>180°\n\n      Body and tail:\n      * Solid tumor contact of \\>180° with the SMA or CA\n      * Solid tumor contact with the CA and aortic involvement\n   2. Venous\n\n   Head\u002Funcinate process:\n   * Unreconstructible SMV\u002FPV due to tumor involvement or occlusion (can be due to tumor or bland thrombus)\n   * Contact with most proximal draining jejunal branch into SMV\n\n   Body and tail:\n\n   • Unreconstructible SMV\u002FPV due to tumor involvement or occlusion (can be due to tumor or bland thrombus)\n4. Subjects have an ECOG performance status ≤ 1\n5. Subjects who are eligible and able to participate in the study and accept to enter the study by signing written informed consent forms\n6. Patients are recovered from toxicities from prior systemic therapies to CTCAE grade 0 or 1 (alopecia ≤ Grade 2 can enroll) and have adequate hematopoietic, liver and renal function at screening and before using study medication\n\n   * Haemoglobin ≥ 8 g\u002FdL\n   * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n   * Absolute lymphocyte count ≥ 1000\u002Fmm3,\n   * Platelets ≥ 100,000 \u002Fmm3\n   * Total white blood cell (WBC) ≥ 3,000 cells \u002Fmm3\n   * Coagulation tests (prothrombin time \\[PT\\], activated partial thromboplastin time \\[APTT\\], International Normalized Ratio \\[INR\\]) \\\u003C 1.5×ULN,\n   * Total bilirubin ≤ 1.5×ULN,\n   * Aspartate aminotransferase (AST)\u002Fserum glutamic oxaloacetic transaminase(SGOT) or Alanineaminotransferase (ALT)\u002Fserum glutamic pyruvic transaminase (SGPT) ≤ 3 x ULN\n   * Estimated Glomerular Filtration Rate (GFR) ≥ 60 mL\u002Fmin (MDRD method)\n\n   Glomerular Filtration Rate (GFR) is calculated using the MDRD formula:\n\n   GFR = 175 x (Standardized SCr)-1.154 x (age)-0.203 x (0.742 if female) x (1.210 if African American)\n7. The subject agrees not to use food supplementary or dietary that contains Angelica sinensis after Screening Visit to Day 21.\n8. All male subjects and female subjects with child-bearing potential (between puberty and 2 years after menopause) should use appropriate contraception method(s) for at least 4 weeks after EF-009 treatment shown below.\n\n   * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception).\n   * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.\n   * Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject\n   * Combination of any two of the following (a+b or a+c, or b+c):\n\n     1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception.\n     2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).\n     3. Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n\nExclusion Criteria:\n\n1. Subjects who have participated in other investigational studies within 4 weeks prior to receive EF-009\n2. Subjects with known or suspected hypersensitivity to EF-009 or the excipient\n3. Subject not eligible for resection without significantly affecting vital function\n4. Subjects with distant metastasis or recurrence of pancreatic cancer\n5. Patient has other severe and\u002For life-threatening disease(s) with life expectancy less than 12 months\n6. Subjects who have an immuno-compromised condition, or is with known autoimmune conditions or is human immunodeficiency virus (HIV) seropositive.\n7. Subjects with medical, social or psychological factors interfering with compliance of the study\n8. Subjects that have on-going moderate to severe organ impairment, other than the study indication, that may confound the efficacy evaluation, safety evaluation or usage of standard chemotherapy\n9. Female subjects that are lactating, pregnant, or planned to become pregnant",{"count":50,"type":21},30,[52,24],"PHASE1","This study is a multi center, open-label, dose escalation, Phase I\u002FIIa study of EF-009 in up to 30 patients with borderline resectable and unresectable pancreatic cancer.",[55],"Pancreatic Cancer","2025-02-24",{"date":58,"type":33},"2025-02-26",{"date":60,"type":21},"2025-09-01",{"date":62,"type":21},"2026-12-01",{"name":39,"class":40},""]