[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kyushu University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100485982","phase-1-clinical-trial-of-gaia-102-for-refractoryrelapse-neuroblastomas-and-other-malignant-pediatric-solid-tumors-100485982",false,"NCT05608148","Clinical Trial of GAIA-102 for Refractory\u002FRelapse Neuroblastomas and Other Malignant Pediatric Solid Tumors","Inclusion Criteria:\n\n1. Patients who have been confirmed to have the following malignant tumor by histological examination\n\n   * cohort A : neuroblastoma or malignant solid tumor with pulmonary metastases, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family, osteosarcoma, other cartilage sarcoma, nephroblastoma, hepatoblastoma, germ cell neoplasma, other rare solid tumor (except brain tumor and brain metastases) .\n   * cohort B : neuroblastoma.\n   * cohort C \\& D : neuroblastoma and other malignant solid tumors, rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma.\n2. Undergoing the following treatment.\n\n   * cohort A \\& B : Patients who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline.\n   * cohort C \\& D : Patients with neuroblastoma who have completed the dinutuximab regimen and still have residual tumor. Patients with rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline.\n3. Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs.\n4. Patients aged from 1years to 24 years at the time of obtaining consent.\n5. Patients with performance status(PS) over 50 (Lansky Performance Status Score less than 16 years old) or (Karnofsky Performance Status over 16 years old) at the time of obtaining consent.\n\nExclusion Criteria:\n\n1. Patients with brain metastases.\n2. Patients diagnosed with cancerous meningitis\n3. Patients who received allogeneic hematopoietic stem cell transplant.\n4. Patients with active autoimmune disease.","ALL","1 Year","24 Years",{"count":19,"type":20},61,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Cohort A(GAIA-102 alone):\n\nConfirm the safety of GAIA-102 alone for refractory\u002Frelapse neuroblastoma or pediatric solid tumors with lung metastases, and decide recommended dose for Phase II.\n\nCohort B(GAIA-102 with Dinutuximab):\n\nConfirm the safety of GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination for refractory\u002Frelapse neuroblastoma and decide recommended dose for Phase II.\n\nCohort C(GAIA-102 with Nivolumab):Confirm the safety of GAIA-102(Follow the recommended doses in Cohort A) with Nivolumab.\n\nCohort D(GAIA-102 with Nivolumab, Teceleukin):\n\nConfirm the safety of GAIA-102(Follow the recommended doses in Cohort A) with Nivolumab, Teceleukin.",[26,27],"Refractory\u002FRelapse Neuroblastoma","Pediatric Solid Tumors","RECRUITING","2025-11-14",{"date":31,"type":32},"2025-11-18","ACTUAL",{"date":34,"type":32},"2022-10-26",{"date":36,"type":20},"2027-08-25",{"name":38,"class":39},"Kyushu University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100472943","phase-1-gaia-102-intraperitoneal-administration-in-patients-with-advanced-gastrointestinal-cancer-of-microsatellite-stable-with-malignant-ascites-100472943","NCT05438459","GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites","Clinical Trial of Repeated Intraperitoneal Administration of GAIA-102 in Patients With Advanced Gastrointestinal Cancer (Gastric Cancer \u002F Pancreatic Cancer) of Microsatellite Stable (MSS) With Malignant Ascites (Phase I \u002F II Investigator-initiated Clinical Trial) (GAIA-102-PD Clinical Trial)","Inclusion Criteria:\n\n1. Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with ascites, as well as unresectable or advanced recurrent pancreatic cancer.\n2. Phase I:\n\n   Patients with gastric cancer who have received 3 or more prior chemotherapy regimens and are refractory or intolerant to these therapies, and patients with pancreatic cancer who have received 2 or more prior chemotherapy regimens and are refractory or intolerant to these therapies.\n\n   Phase II:\n\n   Patients with gastric cancer who have received 2 or more prior chemotherapy regimens, including at least 1 regimen containing an immune checkpoint inhibitor, and are refractory or intolerant to these therapies, and patients with pancreatic cancer who have received 1 or more prior chemotherapy regimens and are refractory or intolerant to these therapies.\n3. Abdominal port placement is possible\n4. No medical history of serious side effects or allergic reactions to pembrolizumab (only for patients in the pembrolizumab combination cohort)\n5. Diagnosed gastric adenocarcinoma or pancreatic cancer with by histological or cytological examination\n6. The patient has been confirmed to be \"negative (not MSS = MSI-high)\" by microsatellite instability (MSI) testing, or \"proficient mismatch repair (pMMR)\" by mismatch repair protein immunohistochemistry testing\n7. The Eastern Cooperative Oncology Group (ECOG) performance status(PS) at the time of informed consent meets the following conditions.\n\n   * Phase I ：0-2\n   * Phase II ：0-1\n8. Patient aged 20years or older\n9. Adequate major organs (bone marrow, heart, lungs, liver, kidneys, etc.) function:\n\n   * Neutrophil ≧1,500\u002Fmm3\n   * hemoglobin ≧8.0 g\u002FdL\n   * Platelet ≧75,000\u002Fmm3\n   * PT-INR≦ 1.5\n   * AST, ALT≦ 3 times the upper limit of reference value\n   * T-Bil≦ 2 times the upper limit of reference value (T-Bil ≦ 3.0mg\u002FdL , when drainage for obstructive jaundice)\n   * eGFR ≧30mL\u002Fmin\u002F1.73m2\n10. Expected to survive for 3 months or more at the enrollment\n11. Written informed consent\n\nExclusion Criteria:\n\n1. Untreated cranial metastases.\n2. Diagnosed with meningeal carcinomatosis\n3. Received allogeneic hematopoietic stem cell transplantation\n4. Participated in other clinical trials \u002F clinical trials within 30 days prior to obtaining written consent and used or had used the investigational product or investigational equipment.\n5. Existence or suspected active autoimmune disease\n6. Continued systemic immunosuppressive therapy with corticosteroids in excess of 10 mg \u002F day in terms of prednisolone or other immunosuppressants within 14 days prior to investigational product administration\n7. Symptomatic interstitial pneumonia, or even if it is not symptomatic, it may interfere with diagnostic imaging in detecting new pneumonitis caused by the investigational product used in the clinical trial.\n8. Have active double cancer and need treatment for the double cancer\n9. Requires treatment as shown in \"Unacceptable Combination \u002F Supportive Therapy\" during the clinical trial period\n10. Have a medical history of severe hypersensitivity to immune checkpoint inhibitors or immune-related adverse events requiring treatment\n11. Have one of the following complications\n\n    * Complication of cerebrovascular disorder with symptoms or history within 6 months before the enrollment\n    * Active gastrointestinal perforation, fistula, diverticulitis\n    * Symptomatic congestive heart failure\n    * Bleeding tendency\n    * Presence of blood clots that may cause embolism on the image\n    * Unhealed fractures (excluding compression fractures associated with osteoporosis) or severe wounds requiring medical treatment\n    * Uncontrollable digestive ulcer\n    * Active infectious diseases requiring intravenous administration of antibiotics, antifungal agents or antiviral agents\n    * HIV antibody positive\n12. At the time of the enrollment, the period from the following prior treatment or the end of treatment has not passed.\n\n    * Surgery (including exploratory laparotomy \u002F examination laparoscope): 2 weeks\n    * Palliative radiotherapy: 1 week\n    * Thoracic drainage: 1 week\n    * Pretreatment antineoplastic (from the last administration): 3 weeks\n    * Biopsy with incision, thoracic biopsy, treatment for trauma (excluding patients without wound healing), etc : 2 weeks\n13. Scheduled thoracotomy or abdominal surgery during the clinical trial period\n14. It is judged that it is difficult to enroll in this study due to clinically significant mental illness.\n15. Pregnant women, lactating women, women who are currently pregnant, or have no intention of contraception for 4 months after consent is obtained.\n16. Allergic to antibiotics and foreign animal-derived ingredients (pig and mouse)\n17. Difficult to participate in the trial by the investigator","20 Years",{"count":50,"type":20},130,[23,52],"PHASE2","Phase I Part :\n\nConfirm the safety of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination for advanced gastrointestinal cancer of microsatellite stable with malignant ascites, and determine the recommended number of doses for Phase II part.\n\nPhase II Part :\n\nResearch the efficacy and safety of as a monotherapy or GAIA-102 and pembrolizumab for advanced gastrointestinal cancer of microsatellite stable with malignant ascites at the recommended dose of GAIA-102 decided in the Phase I part.",[55,56],"Gastric Cancer","Pancreatic Cancer",{"date":31,"type":32},{"date":59,"type":32},"2022-06-08",{"date":61,"type":20},"2029-03-31",{"name":38,"class":39},""]