[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatoblastoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatoblastoma":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,54,79,161,184,221,245,268,291,320,354,386],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100431379","phase-1-b7-h3-specific-chimeric-antigen-receptor-autologous-t-cell-therapy-for-pediatric-patients-with-solid-tumors-3car-100431379",false,"NCT04897321","B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)","Inclusion Criteria:\n\nProcurement and T-cell production eligibility\\*\n\n\\*a previously collected, autologous leukapheresis product can be used for T-cell production\n\n* Age ≤21 years old\n* B7-H3+ solid tumor with measurable disease; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using a previously obtained biopsy; a tumor is considered B7-H3 positive with an H-score ≥100\n* Estimated life expectancy of \\>12 weeks\n* Karnofsky or Lansky (age-dependent) performance score ≥50\n* For females of child bearing age:\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Not lactating with intent to breastfeed\n* Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* Known HIV positivity\n* Severe intercurrent bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)\n* History of hypersensitivity reactions to murine protein-containing products\n* Rapidly progressive disease (in the opinion of the study PIs)\n\nInclusion criteria\n\nTreatment eligibility\n\n* Age ≤21 years old\n* B7-H3+ solid tumor with measurable disease\n* Evidence of relapsed or refractory disease after standard first-line therapy\n* Estimated life expectancy of \\>8 weeks\n* Karnofsky or Lansky (age-dependent) performance score≥50\n* Echocardiogram with a ventricular ejection fraction\n* \\>40%; or shortening fraction ≥25%\n* Adequate renal function defined as creatinine clearance or radioisotope GFR 50 ml\u002Fmin\u002F1.73m2 (GFR 40 ml\u002Fmin\u002F1.73m2 if \\\u003C 2 years of age)\n* Adequate pulmonary function defined as pulse oximetry ≥92% on room air or forced vital capacity (FVC) ≥50% of predicted value\n* Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age\n* Hemoglobin≥ 7g\u002FdL (can be transfused)\n* Platelet count \\>50,000\u002FuL (can be transfused)\n* Absolute neutrophil count (ANC) ≥ 1000\u002FuL\n* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy\n* For females of child bearing age:\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Not lactating with intent to breastfeed\n* If sexually active, agreement to use birth control until 3 months after T-cell infusion. Male partners should use a condom.\n* Available autologous transduced T-cell product that has met GMP release criteria\n* Agreement to participate in long-term follow-up protocol for patients, who have received genetically modified cell products\n\nExclusion criteria\n\n* Known primary immunodeficiency\n* History of HIV infection\n* Severe, uncontrolled intercurrent bacterial, viral or fungal infection\n* History of hypersensitivity reactions to murine protein-containing products\n* Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg\u002Fkg\u002Fday of methylprednisolone, in the 7 days prior to B7-H3-CAR T-cell infusion\n* Receiving systemic therapy in the 14 days prior to CAR T-cell infusion, which will interfere with the activity of the B7-H3-CAR product (in the opinion of the study PIs).\n* Rapidly progressing disease (in the opinion of the study PIs)","ALL","21 Years",{"count":18,"type":19},48,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed\u002Frefractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors.\n\nPrimary objective\n\nTo determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent\u002Frefractory B7-H3+ solid tumors after lymphodepleting chemotherapy\n\nSecondary objective\n\nTo evaluate the antitumor activity of B7-H3-CAR T cells\n\nExploratory objectives\n\n* To evaluate the tumor environment after treatment with B7-H3-CAR T cells\n* To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells\n* To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Pediatric Solid Tumor","Osteosarcoma","Rhabdomyosarcoma","Neuroblastoma","Ewing Sarcoma","Wilms Tumor","Adrenocortical Cancer","Desmoplastic Small Round Cell Tumor","Germ Cell Cancer","Rhabdoid Tumor","Clear Cell Sarcoma","Hepatoblastoma","Melanoma","Carcinoma","Malignant Peripheral Nerve Sheath Tumors","Soft Tissue Sarcoma","RECRUITING","2026-05-18",{"date":44,"type":45},"2026-05-19","ACTUAL",{"date":47,"type":45},"2022-07-06",{"date":49,"type":19},"2028-03-01",{"name":51,"class":52},"St. Jude Children's Research Hospital","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":20,"phases":64,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":53},"100399216","phase-3-a-multi-institutional-study-for-treatment-of-children-with-newly-diagnosed-hepatoblastoma-using-a-modified-phitt-strategy-100399216","NCT04478292","A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy","A Phase 3 Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy Incorporating a Randomized Assessment of Sodium Thiosulfate as Otoprotection for Children With Localized Disease, and Response Adapted Therapy for Patients With Metastatic Disease","Inclusion Criteria:\n\n* Performance Level Patients must have a performance status corresponding to ECOG scores 0, 1, or 2. Use Karnofsky for patients \\>16 years of age and Lansky for patients ≤16 years of age.\n* Diagnosis Patients must be newly diagnosed with histologically-proven primary pediatric HB\n* Emergent Treatment for HB In emergency situation when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy.\n* Prior Therapy Patients may have had surgical resection of the hepatic malignancy prior to enrollment. All other anti-cancer therapy for the current liver lesion is prohibited.\n* Organ Function Requirements\n\nI) Adequate renal function defined as:\n\nCreatinine clearance or radioisotope Glomerular Filtration Rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m2\n\nII) Adequate liver function defined as:\n\nTotal bilirubin ≤ 5 x upper limit of normal (ULN) for age, and Aspartate aminotransferase (AST) or Alanine transaminase (ALT) \\\u003C 10 x upper limit of normal (ULN) for age.\n\nIII) Adequate pulmonary function defined as:\n\nNormal pulmonary function tests (including DLCO) if there is clinical indication for determination (e.g. dyspnea at rest, known requirement for supplemental oxygen)\n\nExclusion Criteria:\n\n* Prior chemotherapy or tumor directed therapy expect for surgical resection of the hepatic malignancy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser)). Therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible.\n* Patients who are currently receiving another investigational drug.\n* Patients who are currently receiving other anticancer agents.\n* Patients with uncontrolled infection.\n* Patients who previously received a solid organ transplant.","18 Years",{"count":63,"type":19},330,[65],"PHASE3","A Phase 3 multi-institutional study for treatment of children with newly diagnosed hepatoblastoma using a modified Paediatric Hepatic International Tumour Trial (PHITT) strategy incorporating a randomized assessment of sodium thiosulfate as auditory protection for children with localized disease, and response adapted therapy for patients with metastatic disease",[36],[69],"hepatoblastoma, sodium thiosulfate, auditory protection","2026-04-28",{"date":72,"type":45},"2026-05-04",{"date":74,"type":45},"2021-03-01",{"date":76,"type":19},"2027-09-30",{"name":78,"class":52},"Shanghai Children's Medical Center",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":15,"minAge":61,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":20,"phases":89,"briefSummary":91,"conditions":92,"keywords":130,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100565188","phase-2-agnostic-therapy-in-rare-solid-tumors-100565188","NCT06638931","Agnostic Therapy in Rare Solid Tumors","Phase II Basket Study to Evaluate the Tissue-agnostic Efficacy of Anti-Programmed Cell Death Protein 1 (Anti-PD1) Monoclonal Antibody in Patients With Advanced Rare Tumors","ANTARES","Inclusion Criteria\n\n1. Age 18 years or older.\n2. Patients with immunohistochemistry for PD-L1 with a combined positive score (CPS) of 10 or higher.\n3. Patients with progression or intolerance to already approved and accessible treatments for the specific neoplasm and population.\n4. Documented disease progression radiologically after the last routine treatment.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Measurable lesion per RECIST v1.1. Lesions previously treated with radiotherapy can only be used as target lesions if they are confirmed to be progressing by imaging before enrollment.\n7. Male participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. No fertile partner;\n   3. Has a fertile partner who agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n\n      and\n   4. Agrees to abstain from sperm donation throughout the study period and for at least 6 months after the last dose of Nivolumab.\n8. Female participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. Agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n9. Estimated life expectancy greater than 12 weeks, as determined by the investigator or delegated sub-investigator.\n10. Preserved organ functions defined by:\n\n    * Absolute neutrophil count ≥ 1,000;\n    * Hemoglobin ≥ 8.0 g\u002FdL (patients may receive transfusions to reach this level);\n    * Platelet count ≥ 100,000;\n    * Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), or ≤ 3.0 × ULN for patients with Gilbert's syndrome;\n    * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases);\n    * Creatinine clearance \\> 30 mL\u002Fmin (estimated by Cockcroft-Gault).\n11. Diagnosis of rare cancer (List I) confirmed by histopathological examination, with the possibility of including other types of rare tumors (incidence of less than 6 in every 100,000) after careful evaluation and approval by the study board.\n\n    * List I:\n\n      * Urachal adenocarcinoma\n      * Parathyroid carcinoma\n      * Nasopharyngeal epithelial tumors\n      * Fibrolamellar carcinoma of any primary site\n      * Angiosarcoma of any primary site\n      * Secretory breast carcinoma\n      * Anal cancer\n      * Metaplastic breast carcinoma\n      * Chromophobe renal carcinoma, Microphthalmia-associated Transcription Factor (MiT) family translocation renal carcinoma; renal carcinoma with Fumarate Hydratase (FH) or Succinate Dehydrogenase (SDH) deficiency\n      * Carcinosarcoma of any primary site\n      * Small intestine cancer\n      * Cholangiocarcinoma\n      * Sertoli-Leydig cell tumors\n      * Cervical cancer of non-epidermoid histology\n      * Tracheal epithelial tumors\n      * Non-cystadenoma salivary gland tumors\n      * Mesothelioma of any site\n      * Neuroblastoma\n      * Adrenal cancer\n      * Penile cancer\n      * Apocrine carcinoma\n      * Fibrosarcoma of any primary site\n      * Cancer of unknown primary site\n      * Hemangioblastoma of any primary site\n      * Thyroid cancer\n      * Hepatoblastoma\n      * Fallopian tube cancer\n      * Leiomyosarcoma of any primary site\n      * Vaginal cancer\n      * Neurofibrosarcoma of any primary site\n      * Gallbladder cancer\n      * Osteosarcoma of any primary site\n      * Bile duct cancer\n      * Clear cell endometrial carcinoma\n      * Yolk sac tumor of any primary site\n      * Non-epidermoid bladder cancer\n      * Vulvar cancer\n      * Kaposi's sarcoma\n      * Epithelial ovarian cancer\n      * Soft tissue sarcoma\n      * Urethral cancer\n      * Granulosa cell tumor of any primary site\n      * Cystadenoma carcinoma\n      * Primitive neuroectodermal tumor of any primary site\n      * Pure or mixed neuroendocrine tumors with neuroendocrine component\n      * Trophoblastic tumor\n\nExclusion Criteria\n\n1. Previous treatment lines with immunotherapy (immune checkpoint inhibitors).\n2. Pregnant or breastfeeding individuals.\n3. Limiting comorbidity, in the opinion of the investigator.\n4. Active infection.\n5. Major surgery within the last 4 weeks.\n6. Functional class II or greater heart failure.\n7. Myocardial infarction or stroke within the last 6 months.\n8. History of pulmonary fibrosis or pneumonitis.\n9. Autoimmune diseases, except for patients with vitiligo and\u002For controlled thyroid\u002Fhypothyroidism without the use of immunosuppressors.\n10. Second invasive primary tumor diagnosed in the last 3 years and\u002For with active disease, except for localized skin tumors (non-melanoma) that have been treated with curative intent.\n11. Patients with prolonged QT interval.\n12. Uncontrolled Central Nervous System (CNS) metastases. Patients who have previously received local treatment, such as radiotherapy, will be eligible if clinical and radiological stability is demonstrated in the 2 weeks prior to the start of treatment. Patients must not be using corticosteroids for managing CNS disease.\n13. Presence of meningeal carcinomatosis.\n14. Worsening renal and liver function in the 14 days prior to enrollment.\n15. History of solid organ transplantation with or without immunosuppression.\n16. Patients with untreated acquired immunodeficiency. Immunocompromised patients may be included as long as they do not have active opportunistic disease and\u002For active infection, after thorough clinical evaluation by the investigator or sub-investigator. HIV-positive patients must have documented undetectable viral load prior to inclusion.\n17. Chronic use of corticosteroids at doses greater than 10 mg\u002Fday of prednisone or equivalent. Patients with adrenal insufficiency of non-autoimmune etiology (e.g., previous bilateral adrenalectomy) may be included if they are clinically compensated with 10 mg\u002Fday of prednisone or equivalent or less.",{"count":88,"type":19},28,[90],"PHASE2","The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.\n\nThe study aims to treat rare malignancies with PD-L1 expression (CPS ≥ 10), regardless of the tumor's tissue type or location. Patients who have not responded to standard treatments will be included, and treatment will last for up to 12 months. The study will assess objective response, progression-free survival, and biomarkers such as PD-L1, ctDNA, and microvesicles, in a multicenter collaborative effort to provide innovative therapeutic options for this underrepresented population",[93,94,95,96,97,98,99,100,101,102,103,104,105,106,28,107,108,109,110,111,112,113,36,114,115,116,117,118,26,119,120,121,122,123,124,40,125,126,127,128,129],"Urachal Cancer","Parathyroid Carcinoma","Fibrolamellar Carcinoma","Angiosarcoma","Secretory Carcinoma of Breast","Anal Neoplasms","Metaplastic Breast Carcinoma","Translocation Renal Cell Carcinoma","Carcinosarcoma","Small Intestine Neoplasms","Cholangiocarcinoma","Sertoli-Leydig Cell Tumor","Adenoid Cystic Carcinoma","Mesothelioma","Adrenal Gland Neoplasms","Penile Neoplasms","Apocrine Carcinoma","Fibrosarcoma","Cancer of Unknown Primary","Hemangioblastoma","Thyroid Neoplasms","Fallopian Tube Neoplasms","Leiomyosarcoma","Vaginal Neoplasms","Neurofibrosarcoma","Gallbladder Neoplasms","Biliary Tract Neoplasms","Clear Cell Endometrial Cancer","Yolk Sac Tumor","Vulvar Neoplasms","Kaposi Sarcoma","Ovarian Epithelial Cancer","Urethral Neoplasms","Granulosa Cell Tumor","Primitive Neuroectodermal Tumor","Neuroendocrine Tumors","Trophoblastic Tumor",[131,94,132,95,96,133,134,99,135,101,136,103,137,138,139,140,106,28,141,142,109,110,111,112,143,36,144,115,145,117,146,26,147,120,121,148,149,123,124,40,150,126,105,127,128,129],"Urachal Adenocarcinoma","Nasopharyngeal Epithelial Tumors","Secretory Breast Carcinoma","Anal Cancer","Chromophobe Renal Carcinoma","Small Intestine Cancer","Sertoli-Leydig Cell Tumors","Non-Squamous Cervical Neoplasm","Tracheal Epithelial Tumors","Non-Adenoid Cystic Salivary Tumors","Adrenal Neoplasm","Penile Cancer","Thyroid Cancer","Fallopian Tube Cancer","Vaginal Cancer","Gallbladder Cancer","Biliary Tract Cancer","Non-Squamous Bladder Cancer","Vulvar Cancer","Urethral Cancer","2026-04-10",{"date":153,"type":45},"2026-04-15",{"date":155,"type":45},"2024-07-16",{"date":157,"type":19},"2028-05",{"name":159,"class":52},"Instituto do Cancer do Estado de São Paulo",8,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":15,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":20,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":53},"100386177","phase-1-vorinostat-in-combination-with-chemotherapy-in-relapsedrefractory-solid-tumors-and-cns-malignancies-100386177","NCT04308330","Vorinostat in Combination With Chemotherapy in Relapsed\u002FRefractory Solid Tumors and CNS Malignancies","A Phase I Study of Vorinostat in Combination With Vincristine, Irinotecan, and Temozolomide in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors and CNS Malignancies","NYMC195","Inclusion Criteria:\n\n* Age: Patients must be less than or equal to 1 year and less than or equal to 30 years of age at initiation of protocol therapy.\n* Diagnosis: Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy.\n* Performance status: Patients over 16 years of age must have a Karnofsky score greater than or equal to 50. Children under 16 years of age must have a Lansky score greater than or equal to 50.\n* Prior therapy: Patients may have received prior therapy with vincristine, irinotecan, or temozolomide. They may not however have received therapy that included a treatment cassette of irinotecan and temozolomide in combination.\n\n  * Prior myelosuppressive therapy: Patients must have not received myelosuppressive therapy in 3 weeks or nitrosourea chemotherapy within 6 weeks of initiation of protocol therapy.\n  * Hematologic growth factor support: Patients may not have received G-CSF within the previous 3 days or peg-filgrastim within the past 7 days.\n  * Biologic anti-neoplastic therapy: At least 21 days or 5 half-lives (whichever is of longer duration) must have elapsed since the last administration of biologic antineoplastic therapy.\n  * Radiation therapy: ≥ 14 days since the last dose of local XRT; ≥ 6 months must have elapsed if prior TBI, craniospinal XRT or ≥ 50% radiation of pelvis; ≥ 6 wks must have elapsed if other substantial BM radiation.\n  * Autologous or allogeneic stem cell transplant: No active graft vs. host disease or need for immunosuppressive therapy. At least 3 months must have passed since neutrophil engraftment.\n* Organ function:\n\nBone marrow function:\n\n* Peripheral absolute neutrophil count (ANC) greater than or equal to 1000 cells\u002FmcL.\n* Platelet count greater than or equal to100,000\u002FmcL and no platelet transfusion within prior 7 days.\n* Hemoglobin greater than or equal to 8 gm\u002FdL\n* Patients with known bone marrow metastatic disease may enroll on the study if they have a peripheral ANC greater than or equal to 750 cells\u002FmcL. They will not be evaluable for hematologic toxicity.\n\n  \\- Adequate liver function:\n* Total bilirubin less than or equal to 1.5x upper limit of normal (ULN) for age.\n* SGPT (ALT) less than or equal to 5x ULN\n* Serum albumin greater than or equal to 2 gm\u002FdL\n\n  \\- Adequate renal function:\n* Creatinine clearance or glomerular filtration rate \\>70 ml\u002Fmin\u002F1.73 m2 or a serum creatinine based on age and gender as follows:\n\nAge Maximum serum creatinine concentration (mg\u002FdL) Male Female 1-\\\u003C2 years 0.6 0.6 2-\\\u003C6 years 0.8 0.8 6-\\\u003C10 years 1 1 10-\\\u003C13 years 1.2 1.2 13-\\\u003C16 years 1.5 1.4 greater than or equal to 16 years 1.7 1.4 The threshold creatinine values in this table were derived from the Schwartz formula to estimate glomerular filtration rates (Schwartz et al. J. Peds. 106; 522. 1985) using child length and stature data from the CDC.\n\n\\- Informed consent: All patients less than 18 years of age must sign a written informed consent. For patients \\\u003C18 years of age, a parent or guardian must sign a written informed consent, unless the patient is an emancipated minor. Childhood assent, when appropriate, should be obtained as well per institutional guidelines.\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding: Women who are pregnant or breast feeding will not be entered on the protocol due to the risks of fetal and teratogenic adverse events with the therapeutic agents used in the protocol therapy.\n* Corticosteroid use: Patients with CNS tumors who have not been on a stable or decreasing dose of corticosteroids for the 7 days prior to the initiation of protocol therapy.\n* Antineoplastic therapy: Patients receiving any other antineoplastic therapy.\n* Medication allergy:\n\nAllergy or intolerance to any of the protocol agents: vincristine, irinotecan, temozolomide, or vorinostat.\n\nAllergy or intolerance to cephalosporins.\n\n* Infection: Patients who have any uncontrolled infection, positive blood culture within 48 hours prior to protocol entry, or diagnosed or receiving therapy for Clostridium difficile infection.\n* Patients may not have taken valproic acid or any other histone deacetylase inhibitor for at least 2 weeks prior to study enrollment.\n* Children with neurofibromastosis Type 1, if being used for treatment of a low grade glioma.","1 Year","30 Years",{"count":172,"type":19},30,[22],"Investigators are testing new experimental drug combinations such as the combination of vorinostat, vincristine, irinotecan, and temozolomide in the hopes of finding a drug that may be effective against tumors that have come back or that have not responded to standard therapy.\n\nThe goals of this study are:\n\n* To find the highest safe dose of vorinostat that can be given together with vincristine, irinotecan, and temozolomide without causing severe side effects;\n* To learn what kind of side effects this four drug combination can cause;\n* To learn about the effects of vorinostat and the combination of vorinostat, vincristine, irinotecan, and temozolomide on specific molecules in tumor cells;\n* To determine whether the combination of vorinosat, vincristine, irinotecan, and temozolomide is a beneficial treatment.",[29,27,30,28,36,176],"Germ Cell Tumor",{"date":153,"type":45},{"date":179,"type":45},"2017-03-17",{"date":181,"type":19},"2027-12-31",{"name":183,"class":52},"New York Medical College",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":15,"minAge":169,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":20,"phases":194,"briefSummary":195,"conditions":196,"keywords":203,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":53},"100604325","phase-1-immunotherapy-for-solid-tumor-malignancies-in-pediatrics-using-interleukin-15-and--21-armored-glypican-3-specific-chimeric-antigen-receptor-t-cells-100604325","NCT07148050","Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells","IMPACT","1. Procurement Eligibility\n\n   Inclusion Criteria:\n   * Diagnosis of a solid tumor expressing GPC3\n   * Lansky or Karnofsky score of \\>=60%\n   * Life expectancy of \\>16 weeks\n   * Informed consent explained to, understood by and signed by patient\u002Fguardian.\n\n   For patients with hepatocellular carcinoma only:\n   * Barcelona Liver Cancer Stage A, B or C\n   * Child-Pugh Turcotte Score \\\u003C7\n\n   Exclusion Criteria:\n   * History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.\n\n     * History of organ transplantation\n     * Known HIV positivity\n     * Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n2. Treatment eligibility\n\nInclusion Criteria:\n\n* Lansky or Karnofsky score of \\>=60%\n* Life expectancy of \\>16 weeks\n* Informed consent explained to, understood by and signed by patient\u002Fguardian.\n* Adequate organ function\n* Adequate laboratory values\n* Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle\n* Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for 12 months after the T-cell infusion.\n* Informed consent explained to, understood by and signed by patient\u002Fguardian.\n\nFor patients with hepatocellular carcinoma only:\n\n* Barcelona Liver Cancer Stage A, B or C\n* Child-Pugh Turcotte Score \\\u003C7\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.\n\n  * History of organ transplantation\n  * Known HIV positivity\n* Active autoimmune or inflammatory disorder\n* Live vaccines within 30 days prior to enrollment\n\n  • Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* Pregnancy or lactation\n* Uncontrolled infection\n* Systemic steroid treatment (≥ 0.5 mg prednisone equivalent\u002Fkg\u002Fday, dose adjustment or discontinuation of medication must occur at least 24hrs prior to CAR T cell infusion)\n* Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.","26 Years",{"count":193,"type":19},21,[22],"This Phase 1, open-label, non-randomized study will enroll pediatric and young adult subjects with relapsed or refractory non-central nervous system (CNS) malignant solid tumors expressing glypican-3 (GPC3) to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to co-express a GPC3-specific chimeric antigen receptor (CAR), interleukin (IL)-15 and IL-21 as well as the inducible caspase 9 (iC9) suicide gene (SC-CAR.GPC3xIL15.21 T cells).\n\nA child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have a blood sample collected, which will be used to bioengineer the CAR T cells targeting their tumor.",[197,198,199,121,200,27,201,30,202,36],"Solid Tumor (Excluding CNS)","Liver Cell Carcinoma","Malignant Rhabdoid Tumor","Liposarcoma","Embryonal Sarcoma of Liver","Hepatocellular Carcinoma",[204,205,206,207,208,209,210,211],"CAR T cell","Pediatric","Young Adult","Non-CNS Tumor","Liver Cancer","Solid Tumor","GPC3","Glypican","2026-02-13",{"date":214,"type":45},"2026-02-17",{"date":216,"type":45},"2025-12-22",{"date":218,"type":19},"2044-04-22",{"name":220,"class":52},"Seattle Children's Hospital",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":61,"enrollmentInfo":228,"targetDuration":4,"studyType":20,"phases":230,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":244},"100616041","phase-2-a-prospective-multicenter-clinical-study-of-sccg-protocol-and-ctdna-5hmc-in-predicting-the-chemotherapy-sensitivity-and-monitoring-the-recurrence-and-metastasis-of-hepatoblastoma-in-children-and-adolescents-100616041","NCT07300449","A Prospective Multicenter Clinical Study of SCCG Protocol and ctDNA 5hmc in Predicting the Chemotherapy Sensitivity and Monitoring the Recurrence and Metastasis of Hepatoblastoma in Children and Adolescents","A Prospective Multicenter Clinical Study of the South China Collaborative Group Protocol for the Treatment of Hepatoblastoma in Children and Adolescents","Inclusion Criteria:\n\n* Patients with primary hepatoblastoma confirmed by pathology.\n\n  * The age of the subjects was less than 18 years old. ③ Obtain the informed consent from the guardians and sign the informed consent form\n\nExclusion Criteria:\n\n* Recurrent hepatoblastoma or other malignant tumor.\n\n  * Age\\> 18 years old. ③ Patients with other tumors and received chemotherapy and abdominal radiotherapy.\n\n    * Heart, brain and kidney failure patients.",{"count":229,"type":19},100,[90],"Hepatoblastoma is the most common malignant liver tumor in infants and preschool children, comprising 65% of pediatric liver malignancies in those under 15, with its incidence on the rise in recent years \\[1\\]. Standard therapy combines surgical resection and chemotherapy: early-stage patients boast a survival rate over 90%, yet high-risk cases only reach around 40%, highlighting unmet treatment needs.\n\nNotably, there is no universal definition for high-risk hepatoblastoma. The U.S. COG (AHEP0731) categorizes it as stage 4 disease, AFP \\\u003C100ng\u002Fml at diagnosis (any stage), or small cell undifferentiated histology; conversely, SIOP includes factors like major vascular invasion (inferior vena cava\u002Fportal vein), intra-abdominal extrahepatic spread, distant metastasis, AFP \\\u003C100ng\u002Fml, or tumor rupture, regardless of PRETEXT stage. To improve outcomes, international teams have tested intensified chemotherapy: Europe's SIOPEL reported that escalated cisplatin-doxorubicin regimens lifted high-risk patients' 3-year overall survival to over 80% \\[2\\], though with heightened toxicity. Similarly, Germany's IPA (ifosfamide-cisplatin-doxorubicin) and Japan's ITEC (ifosfamide-doxorubicin-carboplatin-VP-16) regimens delivered significant survival benefits but also amplified side effects \\[3,4\\].\n\nAgainst this backdrop, the Guangdong Anti-Cancer Association's Pediatric Oncology Committee, led by Sun Yat-sen University Cancer Center and involving 15 hospitals, is launching a multicenter prospective trial to identify optimal chemotherapy regimens for Chinese hepatoblastoma children.\n\nParallelly, liquid biopsy has become an oncology research priority, offering four core advantages over tissue biopsy: non-invasiveness (peripheral blood sampling avoids tumor seeding), real-time genetic\u002Fprogression monitoring (eliminating repeated invasive procedures), comprehensive molecular profiling (overcoming intratumoral heterogeneity), and high accuracy (capturing primary tumor-derived data). Given hepatoblastoma's propensity for early distant metastasis and 30-40% advanced-stage survival (with limited late-stage chemo efficacy), the Nano-5hmC-Seal cfDNA epigenetic profiling method holds promise as a novel biomarker for early diagnosis, treatment prediction, recurrence monitoring, and prognosis assessment in this disease.",[36],[234],"hepatoblastoma","2025-12-10",{"date":237,"type":45},"2025-12-23",{"date":239,"type":45},"2021-06-23",{"date":241,"type":19},"2028-12-31",{"name":243,"class":52},"Sun Yat-sen University",2,{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":252,"targetDuration":4,"studyType":20,"phases":253,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":53},"100531322","phase-1-immunotherapy-for-adults-with-gpc3-positive-solid-tumors-using-il-15-and-il-21-armored-gpc3-car-t-cells-100531322","NCT06198296","Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells","Immunotherapy For Adults With GPC3-Positive Solid Tumors Using Interleukin-15 And -21 Armored Glypican-3-Specific Chimeric Antigen Receptor Expressing Autologous T Cells","Procurement Inclusion Criteria:\n\n* Diagnosis of GPC3-positive\\* solid tumors (as determined by immunohistochemistry with an extent score of \\>=Grade 2 \\[\\>25% positive tumor cells\\] and an intensity score of \\>= 2 \\[scale 0-4\\]).\n* Age ≥21 years\n* Lansky or Karnofsky score ≥60%\n* Life expectancy ≥16 weeks\n* Barcelona Clinic Liver Cancer Stage A, B or C (- Child-Pugh-Turcotte score \\\u003C7 (for patients with hepatocellular carcinoma only)\n* Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent \\* GPC3 expression will be evaluated by standard immunohistochemistry (IHC) at Texas Patients's Hospital\u002FBaylor College of Medicine, Department of Pathology for all patients to meet procurement eligibility. All patients will send at least 5 unstained slides.\n\nProcurement Exclusion Criteria:\n\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies).\n* History of organ transplantation\n* Known HIV positivity\n* Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)\n\nTreatment Inclusion Criteria:\n\n* Diagnosis of GPC3-positive solid tumor\n* Age ≥ 21 years\n* Barcelona Clinic Liver Cancer Stage A, B or C\n* Life expectancy of ≥ 12 weeks\n* Lansky or Karnofsky score ≥ 60%\n* Child-Pugh-Turcotte score \\\u003C 7\n* Adequate organ function:\n* Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml\u002Fmin\n* total bilirubin \\\u003C 3 times ULN for age\n* INR ≤1.7 (for patients with hepatocellular carcinoma only)\n* absolute neutrophil count \\> 500\u002Fµl\n* platelet count \\> 25,000\u002Fµl (can be transfused)\n* Hgb ≥ 7.0 g\u002Fdl (can be transfused)\n* Pulse oximetry \\>90% on room air\n* Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle\n* Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study, as determined by history and physical exam\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.\n* Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent\n\nTreatment Exclusion Criteria:\n\n* Pregnancy or lactation\n* Uncontrolled infection\n* Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday, dose adjustment or discontinuation of medication must occur at least 24hrs prior to CAR T cell infusion)\n* Known HIV positivity\n* Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* History of organ transplantation\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)",{"count":193,"type":19},[22],"The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells.\n\nAntibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise but have not been strong enough to cure most patients.\n\nIn order to get them to kill cancers more effectively, in the laboratory, the study team inserted a new gene called a chimeric antigen receptor (CAR) into T cells that makes them recognize cancer cells and kill them. When inserted, this new CAR T cell can specifically recognize a protein found on solid tumors, called glypican-3 (GPC3). To make this GPC3-CAR more effective, the study team also added two genes called IL15 and IL21 that help CAR T cells grow better and stay in the blood longer so that they may kill tumors better. When the study team did this in the laboratory, they found that this mixture of GPC3-CAR,IL15 and IL21 killed tumor cells better when compared with CAR T cells that did not have IL15 plus IL21 in the laboratory. This study will use those cells, which are called 21.15.GPC3-CAR T cells, to treat patients with solid tumors that have GPC3 on their surface.\n\nThe study team also wanted to make sure that they could stop the 21.15.GPC3-CAR T cells from growing in the blood should there be any bad side effects. In order to do so, they inserted a gene called iCasp9 into the CO-EXIST T cells. This allows us the elimination of 21.15.GPC3-CAR T cells in the blood when the gene comes into contact with a medication called AP1903. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. This drug will only be used to kill the T cells if necessary due to side effects .\n\nThe study team has treated patients with T cells that include GPC3. Patients have also been treated with IL-21 and with IL-15. Patients have not been treated with a combination of T cells that contain GPC3, IL-21 and IL-15. To summarize, this study will test the effect of 21.15.GPC3-CAR T cells in patients with solid tumors that express GPC3 on their surface.\n\nThe 21.15.GPC3-CAR T cells are an investigational product not yet approved by the Food and Drug Administration.",[36,202,30,199,121,27,200,201],[257,258],"GPC3-positive tumors","GPC3-CAR T cells","2025-10-30",{"date":261,"type":45},"2025-11-03",{"date":263,"type":45},"2025-06-10",{"date":265,"type":19},"2043-02-01",{"name":267,"class":52},"Baylor College of Medicine",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":15,"minAge":275,"maxAge":61,"enrollmentInfo":276,"targetDuration":4,"studyType":20,"phases":278,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":53},"100607419","pucotenlimab-combined-with-lenvatinib-and-chemotherapy-in-the-treatment-of-advanced-relapsedrefractory-hepatoblastoma-in-children-100607419","NCT07188311","Pucotenlimab Combined With Lenvatinib and Chemotherapy in the Treatment of Advanced, Relapsed\u002FRefractory Hepatoblastoma in Children","A Single-arm, Open-label, Multicenter Phase II Clinical Study of Pucotenlimab Combined With Lenvatinib and Chemotherapy in the Treatment of Advanced, Relapsed\u002FRefractory Hepatoblastoma in Children","Voluntarily enroll in the study and sign a written informed consent form; Aged 2-18 years, with no gender restrictions; Patients with histologically or cytologically confirmed locally advanced or metastatic hepatoblastoma who have received at least 1 line of systemic therapy. Participants must have experienced disease progression after previous treatment, or have relapsed or refractory disease (failure to achieve complete remission or partial remission after at least 2 courses of first-line treatment); According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one radiologically measurable lesion. Lesions within the field of previous radiotherapy can be considered measurable if progression is confirmed; or there is \"non-measurable disease\" associated with elevated alpha-fetoprotein.\n\nWithin 3 days before the start of study treatment, the Karnofsky Performance Status score (for participants ≥16 years old) or Lansky Performance Status score (for participants \\\u003C16 years old) is at least 50; Expected survival time ≥3 months; Participants with known brain metastases are eligible if they have completed primary brain treatment (such as whole-brain radiotherapy, stereotactic radiosurgery, or complete surgical resection), remain clinically stable, asymptomatic, and have discontinued steroids for at least 28 days before starting study treatment.\n\nArchival tumor tissue or newly obtained biopsy specimens must be available for biomarker analysis before the first dose of the study drug. In cases where archival tissue cannot be provided, tumor patients who cannot obtain biopsy specimens may be enrolled without biopsy after consultation and approval by the sponsor.\n\nFemale patients of childbearing potential (i.e., not postmenopausal or not surgically sterilized) must have a negative serum pregnancy test result within 7 days before administration of the study drug; Female or male patients of childbearing potential must use reliable contraceptive measures during the administration of the study drug and within 60 days after the last dose;\n\nNormal function of major organs, meeting the following criteria:\n\nRoutine blood test:\n\n1. Absolute Neutrophil Count (ANC) ≥1.5×10⁹\u002FL;\n2. Platelet count ≥100×10⁹\u002FL;\n\n   Blood biochemistry test:\n3. Total bilirubin ≤1.5×Upper Limit of Normal (ULN);\n4. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤2.5×ULN (for participants with liver metastases, ALT or AST ≤5×ULN is allowed);\n5. Creatinine ≤1.5×ULN;\n\n   Coagulation function:\n6. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN;\n7. Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN;\n8. Myocardial enzyme profile within the normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are allowed for enrollment).\n\nExclusion Criteria Received chemotherapy within 21 days before the first dose of study drug; received anti-cancer treatment other than chemotherapy or study drug treatment within 28 days (or 5 times the half-life, whichever is shorter); or have not recovered from acute toxicity related to previous treatment.\n\nParticipants with proteinuria greater than 1+ in urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Screeners with urine protein ≥1 g\u002F24 hours will be ineligible for the study.\n\nGastrointestinal malabsorption, gastrointestinal anastomosis, or any other conditions that may affect the absorption of lenvatinib.\n\nClinically symptomatic central nervous system metastases and\u002For carcinomatous meningitis, or a history of leptomeningeal carcinomatosis; Any other active malignant tumors within the past 24 months, except for recurrent hepatoblastoma that is the reason for participation in this study; A history of congenital or acquired immunodeficiency; Previous allogeneic stem cell or solid organ transplantation; Previous receipt of immune checkpoint inhibitors (including but not limited to pembrolizumab, nivolumab), lenvatinib, or irinotecan; A history of (non-infectious) pneumonia requiring steroid treatment or current pneumonia.\n\nPatients with known or suspected allergic history to putilizumab or similar drugs, a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergies to excipients of the study drug; A history of gastrointestinal bleeding within 4 weeks before enrollment, or a clear tendency for gastrointestinal bleeding (e.g., known active local ulcer lesions, fecal occult blood ≥++, and if persistent fecal occult blood +, gastroscopy should be performed), or other conditions judged by the investigator that may cause gastrointestinal bleeding (e.g., severe gastric fundus\u002Fesophageal varices); Cardiac diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe\u002Funstable angina pectoris, or coronary artery bypass grafting within the past 6 months; congestive heart failure (New York Heart Association \\[NYHA\\] class \\>2); arrhythmias that are poorly controlled or require pacemaker treatment; hypertension uncontrolled by drugs (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n\nActive infections, including:\n\n1. Positive for human immunodeficiency virus (HIV) (HIV1\u002F2 antibodies);\n2. Active tuberculosis;\n3. Other uncontrolled active infections (CTCAE V5.0 \\>Grade 2); Failure to recover from surgery, such as unhealed incisions or severe postoperative complications; Vaccination with any live-attenuated vaccine within 4 weeks before enrollment or likely to be administered during the study period; seasonal influenza vaccines without live viruses are allowed.\n\nPregnant or lactating women; A history of alcohol, psychotropic drug, or other substance abuse within the past 6 months; Any other conditions that the investigator deems make the patient ineligible for enrollment.","2 Years",{"count":277,"type":19},24,[279],"NA","This study is a single-cohort study. Pediatric patients with advanced, relapsed\u002Frefractory hepatoblastoma who have previously failed first-line or higher systemic therapy will receive 2 cycles of treatment with sintilimab combined with lenvatinib and chemotherapy (irinotecan). Patients may discontinue treatment due to disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or other reasons specified in the protocol, whichever occurs first.\n\n* Dose setting:\n* Sintilimab: The recommended dose is 3 mg\u002Fkg (maximum dose not exceeding 200 mg per administration), administered by intravenous infusion (60±15 minutes) once daily on Day 1.\n* Lenvatinib: 7 mg\u002Fm² (maximum 12 mg), taken orally once daily on Days 1-21.\n* Chemotherapy (irinotecan hydrochloride injection):\n* Irinotecan hydrochloride injection: 50 mg\u002Fm², administered by intravenous infusion once daily on Days 1-5.\n* Each 3 weeks constitutes one cycle. For patients who discontinue the study drug without radiological progression, follow-up and tumor assessment will continue until progressive disease (PD) occurs, new anti-tumor therapy is initiated, or death.\n* Tumor tissues and peripheral blood of patients will be collected for relevant tests.",[36,282],"Pediatric Cancer","2025-09-16",{"date":285,"type":45},"2025-09-23",{"date":287,"type":45},"2025-04-10",{"date":289,"type":19},"2027-12-10",{"name":243,"class":52},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":15,"minAge":298,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":302,"phases":4,"briefSummary":303,"conditions":304,"keywords":309,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":53},"100359417","molecular-basis-of-pediatric-liver-cancer-100359417","NCT03959800","Molecular Basis of Pediatric Liver Cancer","Genetic and Molecular Basis of Pediatric Liver Cancer","Inclusion Criteria:\n\n* Prior or current treatment for a childhood liver tumor, malignant or benign, at age \\\u003C21 years.\n* Biological parents and siblings of eligible children.\n\nExclusion Criteria:\n\n* No prior or current treatment for a childhood liver tumor.\n* Non-biological parents, legal guardians, or non-biological siblings of eligible children.","0 Years","99 Years",{"count":301,"type":19},1600,"OBSERVATIONAL","The purpose of this retrospective and prospective project is to understand the molecular and genetic basis of liver cancer of childhood. Understanding the molecular and genetic bases of liver cancers can offer a better classification based on tumor biology, mechanisms and predisposition.",[305,306,307,36,202,308],"Childhood Liver Cancer","Liver Malignant Tumors","Embryonal Sarcoma of Liver (Disorder)","Rhabdoid Tumor of Liver",[36,202,310],"Pediatric Liver Cancer","2025-09-05",{"date":313,"type":45},"2025-09-12",{"date":315,"type":45},"2015-06-22",{"date":317,"type":19},"2029-06-30",{"name":319,"class":52},"University of Pittsburgh",{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":15,"minAge":61,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":302,"phases":4,"briefSummary":329,"conditions":330,"keywords":338,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":353},"100557710","a-french-multicenter-observational-retrospective-study-of-rare-primary-liver-cancers-100557710","NCT06541652","A French Multicenter Observational Retrospective Study of Rare Primary Liver Cancers","FFCD-2205","Inclusion Criteria:\n\n* 18 years of age or older,\n* with histologically proven hepato-cholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma or hepatic angiosarcoma\n* diagnosed after January 01, 2018 living or deceased at the time of registration in the cohort\n* for living patients who have not objected to the research: (note of non-objection to be attached° agreeing to participate in ancillary studies must sign the biological consent form for participation in biological studies.\n\nExclusion Criteria:\n\n* without social security\n* No access to tumor block",{"count":328,"type":19},150,"The aim of this French multicenter retrospective study is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences. This retrospective cohort will be the backbone of future translational studies aimed at identifying new molecular, histological, circulating and radiological tumor biomarkers, potentially useful at every stage of diagnosis and prognostic or theranostic evaluation.",[331,95,332,36,333,334,335,336,337,103],"Hepatocholangiocarcinoma","Hepatic Epithelioid Hemangioendothelioma","Hepatic Neuroendocrine Carcinoma","Hepatic Carcinosarcomas","Hepatic Cystadenoma","Hepatic Leiomyosarcomas","Hepatic Angiosarcomas",[339,340,341,342,343],"rare primary liver cancers","LIVER","HEPATIC","COHORT","RISK FACTORS","2025-08-04",{"date":346,"type":45},"2025-08-05",{"date":348,"type":45},"2024-03-26",{"date":350,"type":19},"2031-02",{"name":352,"class":52},"Federation Francophone de Cancerologie Digestive",40,{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":15,"minAge":169,"maxAge":16,"enrollmentInfo":362,"targetDuration":4,"studyType":20,"phases":364,"briefSummary":365,"conditions":366,"keywords":371,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":244},"100411195","phase-1-et140203-t-cells-in-pediatric-subjects-with-hepatoblastoma-hcn-nos-or-hepatocellular-carcinoma-100411195","NCT04634357","ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma","An Open-Label, Dose Escalation, Phase I\u002FII Clinical Trial of ET140203 T Cells in Pediatric Subjects With Relapsed\u002FRefractory Hepatoblastoma (HB), Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS), or Hepatocellular Carcinoma (HCC)","ARYA-2","Inclusion Criteria:\n\n1. Histologically confirmed HB, HCN-NOS, or HCC with serum AFP \\>100ng\u002FmL at the time of screening and following the most recent line of therapy.\n2. Disease reoccurrence after remission following initial standard-of care (SOC) treatment (i.e., relapse) or failure of response to SOC treatment (i.e., refractory).\n3. Age ≥ 1 year and ≤ 21 years.\n4. Molecular Human Leukocyte Antigen (HLA) class I allele typing that confirms subject carries at least one HLA-A2 allele.\n5. Life expectancy of \\> 4 months per the Investigator's opinion.\n6. Lansky or Karnofsky Performance Scale ≥ 70.\n7. For enrollment to the dose-finding cohort, subjects must have at least one (1) lesion ≥ 5 mm in diameter or two (2) or more lesions ≥ 3 mm in diameter. For the dose-expansion cohort, subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n8. Child-Pugh score of A6 or better.\n9. Adequate organ function.\n\nExclusion Criteria:\n\n1. Recurrent HB who are candidates for complete surgical resection (e.g., isolated pulmonary relapse amendable to pulmonary metastasectomy).\n2. Pre-existing illness including heart failure, uncontrolled pulmonary disease not cancer-related, or psychiatric illness\u002Fsocial situation that would limit compliance with study requirements.\n3. Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.\n4. Any known active malignancy (other than HB, HCN-NOS, or HCC).\n5. Pregnant or lactating women.\n6. Received the following within two (2) weeks of leukapheresis or within two (2) weeks of conditioning chemotherapy: cytotoxic chemotherapy, radiation, other anti-cancer therapies (including immunotherapeutic agents), immunosuppressive therapy, or systemic corticosteroids at doses greater than 5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids. (Note: Topical and inhaled corticosteroids in standard doses and physiological replacement doses of corticosteroids for adrenal insufficiency are allowed).\n7. Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.\n8. Contraindication for receipt of conditioning chemotherapeutic agents including Fludarabine and Cyclophosphamide.\n9. Active autoimmune disease requiring systemic immunosuppressive therapy.\n10. Compromised circulation in the main portal vein, hepatic vein, or vena cava due to partial or complete obstruction which, in the opinion of the Investigator, would make the subject unsuitable for the study.\n11. History of organ transplant.\n12. HB, HCN-NOS, or HCC involving greater than 50% of the liver (volumetric).",{"count":363,"type":19},15,[22,90],"Open-label, dose escalation, multi-center, Phase I\u002FII clinical trial to assess the safety\u002Ftolerability and determine the recommended Phase II Dose (RP2D) of ET140203 T-cells in pediatric subjects who are AFP-positive\u002FHLA-A2-positive and have relapsed\u002Frefractory HB, HCN-NOS, or HCC.",[36,367,368,369,208,370],"Hepatocellular Carcinoma (HCC)","Liver Neoplasms","Metastatic Liver Cancer","HEMNOS",[372,205,373,367,208,374,369,375,370],"Relapsed\u002FRefractory Hepatoblastoma (HB)","Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS)","T-cell therapy","Liver neoplasms","2025-04-07",{"date":378,"type":45},"2025-04-09",{"date":380,"type":45},"2022-07-19",{"date":382,"type":19},"2028-01-31",{"name":384,"class":385},"Eureka Therapeutics Inc.","INDUSTRY",{"id":387,"slug":388,"hasResults":11,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":11,"sex":15,"minAge":298,"maxAge":61,"enrollmentInfo":392,"targetDuration":4,"studyType":302,"phases":4,"briefSummary":394,"conditions":395,"keywords":397,"overallStatus":401,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":4},"100579326","accurate-diagnosis-and-grading-of-pediatric-solid-tumors-based-on-pathological-large-models-100579326","NCT06822842","Accurate Diagnosis and Grading of Pediatric Solid Tumors Based on Pathological Large Models","Inclusion Criteria:\n\n1. Neuroblastoma (NB): For newly diagnosed patients with NB aged 0-18 years, the diagnosis criteria are one of the following two items: (1) the patient's tumor tissue has obtained a positive pathological diagnosis under the light microscope; (2) Bone marrow biopsy or aspiration revealed characteristic neuroblastoma cells, which were small round cells, arranged in a nested or chrysanthemum clump or positive staining for anti-GD2 antibodies, and accompanied by an increase in urinary vanillylmandelic acid (VMA) and an increase in blood neuron-specific enolase (NSE).\n2. Wilms tumor (nephroblastoma): patients aged 0-18 years old who have been diagnosed with Wilms tumor by histopathology.\n3. Hepatoblastoma (HB): Patients aged 0-18 years who have been diagnosed with hepatoblastoma by histopathology.\n4. Medulloblastoma (MB): Patients aged 0-18 years with a confirmed histopathological diagnosis of medulloblastoma.\n5. rhabdomyosarcoma (RMS): patients aged 0-18 years old who have been diagnosed with medulloblastoma by histopathology.\n\nExclusion Criteria:\n\n1. The patient's medical record and treatment follow-up information are incomplete; HE is not stained or faded\n2. Those who have 2 or more types of tumors at the same time;\n3. Those who do not meet the enrollment criteria.\n4. Tumor subtype with less than 3 WSI images",{"count":393,"type":19},2000,"Pediatric malignancies are the second leading cause of death in the pediatric population, with solid tumors accounting for approximately 60% of all pediatric malignancies. The pathological diagnosis of pediatric solid tumors is highly complex and specialized, because of its diverse tissue morphology, rare tumor subtypes and lack of labeling data, the traditional pathological diagnosis relies on the experience of senior pathologists, but in actual clinical practice, due to the lack of expert resources and inconsistent diagnostic standards, more efficient and accurate auxiliary diagnostic tools are urgently needed. In this study, we aim to construct a multimodal dataset by collecting high-quality pathological images and pathological diagnosis results of pediatric solid tumors (neuroblastoma, medulloblastoma, Wilms tumor, hepatoblastoma, rhabdomyosarcoma, etc.), and introduce medical knowledge enhancement strategies on this basis, and improve the medical reasoning ability and adaptability to fine-grained pathological tasks by injecting domain knowledge (such as molecular characteristics of tumors, pathological grading standards, diagnostic rules, etc.) into the model. Through the model, the representation space of images and texts is unified, and diversified diagnostic tasks of pediatric solid tumors such as tumor region segmentation, cancer detection, and tumor subtype identification are realized, providing intelligent support for the accurate diagnosis and personalized treatment of pediatric solid tumors.",[28,396,30,36,27],"Medulloblastoma",[398,399,400],"Machine learning","Diagnosis","Pathological classification","NOT_YET_RECRUITING","2025-02-06",{"date":404,"type":45},"2025-02-12",{"date":406,"type":19},"2025-02-01",{"date":408,"type":19},"2025-04-30",{"name":410,"class":52},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine"]