[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liposarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liposarcoma":513},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,44,126,149,178,201,231,264,296,325,345,366,387,416,442,468,488],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100557680",false,"NCT06541262","Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors","Phase I\u002FII Study of Silmitasertib (CX-4945) in Combination With Chemotherapy in Children and Young Adults With Relapsed Refractory Solid Tumors","Inclusion Criteria:\n\n1. Age: Less than 30 years old at initial diagnosis\n2. Pathology All subjects must have a confirmed diagnosis of tumor type. Phase I: Relapsed\u002Frefractory solid tumors: Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma\n\n   Phase II:\n   * Relapsed\u002Frefractory Neuroblastoma\n   * Relapsed\u002Frefractory Ewing sarcoma\n3. Tumor assessment:\n\n   Disease assessment is required for eligibility and must be done after last dose of previous therapy and prior to first dose of study drug.\n4. Disease Status:\n\n   Relapsed\u002FRefractory Neuroblastoma Relapsed disease defined as neuroblastoma that was previously in remission after standard therapy (at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation and surgery, followed by immunotherapy, or according to a standard high-risk treatment\u002Fneuroblastoma protocol) and has now relapsed and is in any number of relapses.\n\n   Refractory disease defined as High-risk neuroblastoma (as defined by INRG) that failed to achieve CR after at least 4 cycles of aggressive multi-drug induction chemotherapy, progression during upfront therapy or with disease remaining after standard immunotherapy.\n\n   International Neuroblastoma Risk Group Staging System (INRG) High Risk NB defined as one of the following:\n   1. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M with MYCN amplification\n   2. Age ≥ 547 days and INRG Stage M regardless of biologic features\n   3. Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to Stage M without systemic chemotherapy\n   4. Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy\n\n   Relapsed\u002Frefractory Sarcoma Subjects that have relapsed following standard of care therapy or having progressed during standard of care therapy. Standard of care therapy for sarcoma includes multi-agent chemotherapy with local control consisting of either surgery or radiation therapy.\n5. Measurable or evaluable disease, including at least one of the following:\n\n   * Measurable tumor by CT or MRI\n   * MIBG or PET that is positive for disease\n   * Bone Marrow biopsy\u002Faspirate that is positive for disease\n6. Timing from prior therapy:\n\n   Subjects must have fully recovered from the acute toxic effects of all prior anti- cancer therapy and be within the following timelines:\n   1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study.\n   2. Small Molecule Inhibitors (anti-neoplastic agent): At least 2 weeks from the completion of therapy with a small molecule inhibitor.\n   3. Immunotherapy: At least 4 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines, CAR-T cells, anti-GD2 Monoclonal antibodies (ex. naxitamab, dinutuximab, etc.).\n   4. Radiotherapy: At least 30 days since the last treatment except for radiation delivered with palliative intent to a non-target site.\n   5. Stem Cell Transplant:\n\n      * Allogeneic: No evidence of active graft vs. host disease\n      * Allogeneic\u002FAutologous: ≥ 2 months must have elapsed since transplant.\n   6. MIBG Therapy: At least 6 weeks since treatment with MIBG therapy.\n7. Subjects must have a Lansky or Karnofsky Performance Scale score of \\>\u002F= 50.\n8. Subjects must have adequate organ function at the time of enrollment:\n\n   * Cardiac: Subjects must have a QTcF ≤ 480 msc.\n   * Hematological: Hematological recovery as defined by ANC ≥750\u002FμL\n   * Liver: Adequate liver function as defined by AST and ALT \\\u003C5x upper limit of normal\n   * Renal: Subjects must have adequate renal function defined as:\n   * estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (for subjects \\\u003C 17 years old) (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n   * estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (for subjects ≥17 years old (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n   * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n9. Subjects of childbearing potential must have a negative serum pregnancy test. Subjects of childbearing potential must agree to use effective measures to avoid pregnancy.\n10. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).\n\nExclusion Criteria:\n\n1. Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.\n2. Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the hematological and bone marrow suppression effects of prior therapy.\n3. Subjects who are currently receiving Vitamin K antagonists (warfarin).\n4. Subjects who are currently receiving the class of lipid-lowering medications HMG-CoA reductase inhibitors (statins).\n5. Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n6. Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.\n7. Subjects with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the subject's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n8. Subjects with any of the following gastrointestinal disorders:\n\n   1. Active malabsorption (e.g. short gut) syndrome.\n   2. Uncontrolled diarrhea (excess of 4 stools\u002Fday)\n   3. Gastritis, ulcerative colitis, Chron's disease or hemorrhagic coloproctitis\n   4. History of gastric or small bowel surgery involving any extent of gastric or small bowel resection\n9. Lactating subjects are not eligible unless they have agreed to not breastfeed their infants. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing subject with silmitasertib. (NOTE: breast milk cannot be stored for future use while the nursing subject is being treated on study.)\n10. Subjects with a history of any other malignancy.","ALL","30 Years",{"count":18,"type":19},104,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","The purpose of this study is to evaluate the investigational drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. An investigational drug is one that has not been approved by the U.S. Food \\& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.\n\nThe goals of this part of the study are:\n\n* Establish a recommended dose of silmitasertib in combination with chemotherapy\n* Test the safety and tolerability of silmitasertib in combination with chemotherapy in subjects with cancer\n* To determine the activity of study treatments chosen based on:\n* How each subject responds to the study treatment\n* How long a subject lives without their disease returning\u002Fprogressing",[26,27,28,29,30],"Neuroblastoma","Ewing Sarcoma","Osteosarcoma","Rhabdomyosarcoma","Liposarcoma","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2024-10-30",{"date":39,"type":19},"2035-11-01",{"name":41,"class":42},"Milton S. Hershey Medical Center","OTHER",22,{"id":45,"slug":4,"hasResults":10,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":52,"conditions":53,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100534472","NCT06239272","NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)","Inclusion Criteria:\n\nInclusion Criteria - All Patients\n\n* Patients must be ≤ 30 years at the time of the biopsy that established the diagnosis of NRSTS.\n* Surgical Resection: Patients who had an upfront resection prior to enrollment will be eligible if they are able to begin therapy within 28 days of resection assuming other eligibility criteria are met. Delayed resection is preferred for all patients with intermediate and high-risk disease.\n* Lansky performance status score ≥ 60 for patients ≤ 16 years of age. Karnofsky performance status score ≥ 60 for patients \\>16 years of age. Note patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\nDiagnosis\n\n• Patients with CIC-DUX 4 rearranged sarcomas will be enrolled on the high-risk stratum only, regardless of presence of metastasis, size, or resection status.\n\nPatient has low-risk disease if the patient has a:\n\n* Low-grade tumor of any size where R0 or R1 surgical margins are anticipated or achieved.\n* High-grade tumors that are \\\u003C 5 cm where R0 or R1 resection margins are anticipated or achieved.\n\nPatient must have adequate organ function in the organs that will be within the radiotherapy field.\n\nAdequate renal function defined as:\n\n* Creatinine clearance or radioisotope GFR \\> 70 mL\u002Fmin\u002F1.73 m2, or\n* A normal serum creatinine based on age\u002Fgender as follows\n\nAge Maximum Serum Creatinine (mg\u002FdL) Male Female 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4 \\> 16 years 1.5 1.4\n\nAdequate liver function defined as:\n\n* Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) for age\n* SGOT (AST) or SGPT (ALT) \\\u003C 2.5 x ULN for age\n\nAdequate cardiac function defined as:\n\n* Ejection fraction of \\> 55% by echocardiogram or cardiac MRI\n* QTc \\\u003C 480 msec\n\nAdequate pulmonary function defined as:\n\n* No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading \\> 94% on room air if there is clinical indication for determination.\n\nInclusion Criteria - Intermediate and High Risk Participants\n\nPatient has intermediate-risk if the patient has a:\n\n* Low-grade non-metastatic initially unresectable disease at study enrollment where delayed resection is planned.\n* High-grade \\\u003C 5 cm non-metastatic initially unresectable disease at study enrollment where delayed resection is planned. Of note, patients enrolled on the low-risk arm who were unable to achieve gross total resection where delayed re-resection is planned are eligible for this arm.\n* High-grade tumor \\> 5 cm that is potentially resectable.\n\nPatient high-risk if the patient has:\n\n* Metastatic disease at presentation\n* Unresectable disease at study enrollment where delayed resection is not anticipated. Of note, patients enrolled on the low-risk arm who were unable to achieve gross total resection where delayed re-resection is not-planned are eligible for this arm.\n* CIC-DUX4 rearranged sarcoma\n\nOrgan Function\n\nAdequate bone marrow function defined as:\n\n* Absolute neutrophil count \\> 1000\u002FµL\n* Platelet count \\> 100,000\u002FµL\n* Hemoglobin \\> 8 g\u002FdL for patients \\\u003C 16 years of age\n* Hemoglobin \\> 9 g\u002FdL for patients \\> 16 years of age\n\nNote: No transfusions are permitted 7 days prior to laboratory studies to determine eligibility.\n\nAdequate renal function defined as:\n\n* Creatinine clearance or radioisotope GFR \\> 70 mL\u002Fmin\u002F1.73 m2, or\n* A normal serum creatinine based on age\u002Fgender as follows\n\nAge Maximum Serum Creatinine (mg\u002FdL) Male Female 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4 \\> 16 years 1.5 1.4\n\nAdequate liver function defined as:\n\n* Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) for age\n* SGOT (AST) or SGPT (ALT) \\\u003C 2.5 x ULN for age\n\nAdequate cardiac function defined as:\n\n* Ejection fraction of \\> 55% by echocardiogram or cardiac MRI\n* QTc \\\u003C 480 msec\n\nAdequate pulmonary function defined as:\n\n* No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading \\> 94% on room air if there is clinical indication for determination.\n\nAnticoagulation\n\nPatients on low molecular weight heparin, warfarin (with a stable INR), or direct oral anticoagulants (DOAC) who have been on a stable dose of are eligible. Patients being treated for a pulmonary embolism or deep venous thrombosis (DVT) must have been treated for a minimum of 6 weeks prior to starting therapy treatment.\n\nLife Expectancy\n\nPatient must have a life expectancy of at least 3 months with appropriate therapy.\n\nExclusion Criteria:\n\n* Patients with known primary CNS sarcoma or CNS metastases are not eligible. Note: Brain imaging is not an eligibility requirement. Tumors with intracranial extension will be allowed.\n* Patients with the following histologic diagnosis are not eligible: intermediate locally aggressive tumors as defined by WHO, malignant rhabdoid tumor, alveolar soft part sarcoma, infantile fibrosarcoma, unresectable\u002Fmetastatic dermatofibrosarcoma protuberans, inflammatory myofibroblastic tumor, desmoid fibromatosis, rhabdomyosarcoma, desmoplastic small round cell tumor, BCOR-CCNB3 fusion positive sarcoma.\n* Bleeding diathesis: Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: Patients aged \\> 17 years with excess of 2.5 mL of hemoptysis are not eligible).\n* Uncontrolled hypertension: Patients with uncontrolled hypertension (CTCAE v5 Grade ≥ 2) are ineligible. Hypertension must be well controlled on stable doses of medication for at least two weeks.\n\nPrior Therapy\n\n* Patients must have had no prior systemic therapy for the treatment of the NRSTS\n* Patients must have had no prior anthracycline or ifosfamide chemotherapy\n* Patients must have had no prior use of pazopanib or similar multi-targeted TKI.\n\nPatients must have had no prior radiotherapy to tumor-involved sites.\n\nNote: Patients previously treated for a non-NRSTS cancer are eligible provided they meet the prior therapy requirements. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded.\n\n* CYP3A4 Substrates WITH Narrow Therapeutic Indices: Patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible. Note: the use of fentanyl is permitted.\n* CYP3A4 Inhibitors: Patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin, many NNRTIs, diltiazem, verapamil, and grapefruit juice are not eligible.\n* CYP3A4 Inducers: Patients chronically receiving drugs that are known potent CYP3A4 inducers within 14 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort are not eligible (with the exception of glucocorticoids).\n* Certain medications that are associated with a risk for QTc prolongation and\u002For Torsade's de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible.\n* Subjects with any condition that may impair the ability to absorb oral medications\u002Finvestigational product including:\n\n  * prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel\n  * active peptic ulcer disease\n  * malabsorption syndrome\n\n3.4.12 Thyroid Replacement Therapy: Patients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 4 weeks prior to study enrollment.\n\n3.4.13 Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:\n\n* active peptic ulcer disease\n* known intraluminal metastatic lesions\n* inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation\n* history of abdominal fistula, gastrointestinal perforation or intra- abdominal abscess within 28 days prior to beginning study treatment.\n\n3.4.14 Pulmonary embolism or DVT. Patients must not have experienced:\n\n* An untreated pulmonary embolism or DVT in last 6 months or\n* treated pulmonary embolism or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\n* arterial thrombosis in last 12 months\n\nHistory of serious or non-healing wound, ulcer, or bone fracture.\n\nUncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nHIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pazopanib. In addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n\nPatients who are receiving any other investigational agent(s).\n\nPregnancy and Breast Feeding\n\n* Pregnancy and Breast Feeding Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies.\n* Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment.\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.\n* Unwillingness to use an effective contraceptive method for the duration of their study participation and for at least 1 month after treatment is completed if sexually active with reproductive potential.",{"count":50,"type":19},139,[22,23],"The study participant has been diagnosed with non-rhabdomyosarcoma (NRSTS).\n\nPrimary Objectives\n\nIntermediate-Risk\n\n* To estimate the 3-year event-free survival for intermediate-risk patients treated with ifosfamide, doxorubicin, pazopanib, surgery, and maintenance pazopanib, with or without RT.\n* To characterize the pharmacokinetics of pazopanib and doxorubicin in combination with ifosfamide in intermediate-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and pazopanib and doxorubicin pharmacokinetics.\n\nHigh-Risk\n\n* To estimate the maximum tolerated dose (MTD) and\u002For the recommended phase 2 dosage (RP2D) of selinexor in combination with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib in high-risk participants.\n* To characterize the pharmacokinetics of selinexor, pazopanib and doxorubicin in combination with ifosfamide in high-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and selinexor, pazopanib and doxorubicin pharmacokinetics.\n\nSecondary Objectives\n\n* To estimate the cumulative incidence of primary site local failure and distant metastasis-free, disease-free, event-free, and overall survival in participants treated on the risk-based treatment strategy defined in this protocol.\n* To define and describe the CTCAE Grade 3 or higher toxicities, and specific grade 1-2 toxicities, in low- and intermediate-risk participants.\n* To study the association between radiation dosimetry in participants receiving radiation therapy and the incidence and type of dosimetric local failure, normal adjacent tissue exposure, and musculoskeletal toxicity.\n* To evaluate the objective response rate (complete and partial response) after 3 cycles for high-risk patients receiving the combination of selinexor with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib.\n* To assess the relationship between the pharmacogenetic variation in drug-metabolizing enzymes or drug transporters and the pharmacokinetics of selinexor, pazopanib, and doxorubicin in intermediate- or high-risk patients.\n\nExploratory Objectives\n\n* To explore the correlation between radiographic response, pathologic response, survival, and toxicity, and tumor molecular characteristics, as assessed through next-generation sequencing (NGS), including whole genome sequencing (WGS), whole exome sequencing (WES), and RNA sequencing (RNAseq).\n* To explore the feasibility of determining DNA mutational signatures and homologous repair deficiency status in primary tumor samples and to explore the correlation between these molecular findings and the radiographic response, survival, and toxicity of patients treated on this protocol.\n* To explore the feasibility of obtaining DNA methylation profiling on pretreatment, post-induction chemotherapy, and recurrent (if possible) tumor material, and to assess the correlation with this and pathologic diagnosis, tumor control, and survival outcomes where feasible.\n* To explore the feasibility of obtaining high resolution single-cell RNA sequencing of pretreatment, post-induction chemotherapy, and recurrent (if possible) tumor material, and to characterize the longitudinal changes in tumor heterogeneity and tumor microenvironment.\n* To explore the feasibility of identifying characteristic alterations in non-rhabdomyosarcoma soft tissue sarcoma in cell-free DNA (cfDNA) in blood as a non-invasive method of detecting and tracking changes during therapy, and to assess the correlation of cfDNA and mutations in tumor samples.\n* To describe cardiovascular and musculoskeletal health, cardiopulmonary fitness among children and young adults with NRSTS treated on this protocol.\n* To investigate the potential prognostic value of serum cardiac biomarkers (high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro B-type natriuretic peptide (NT-Pro-BNP), serial electrocardiograms (EKGs), and serial echocardiograms in patients receiving ifosfamide, doxorubicin, and pazopanib, with or without selinexor.\n* To define the rates of near-complete pathologic response (\\>90% necrosis) and change in FDG PET maximum standard uptake value (SUVmax) from baseline to week 13 in intermediate risk patients with initially unresectable tumors treated with induction pazopanib, ifosfamide, and doxorubicin, and to correlate this change with tumor control and survival outcomes.\n* To determine the number of high-risk patients initially judged unresectable at diagnosis that are able to undergo primary tumor resection after treatment with ifosfamide, doxorubicin, selinexor, and pazopanib.\n* To identify the frequency with which assessment of volumes of interest (VOIs) of target lesions would alter RECIST response assessment compared with standard linear measurements.",[54,30,55,56,57,58,59,60,61],"Adipocytic Neoplasm","Atypical Fibroxanthoma","Angiomatoid Fibrous Histiocytoma","Myoepithelioma","Fibrosarcoma NOS","Myxofibrosarcoma","Angiosarcoma","Osteosarcoma, Extraskeletal",[63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115],"non-rhabdomyosarcoma","Proton therapy","Soft tissue sarcoma","Adipocytic Tumors","Fibroblastic\u002Fmyofibroblastic Tumors","Dermatofibrosarcoma protuberans, fibrosarcomatous","Solitary fibrous tumor","Inflammatory myofibroblastic tumor","Low-grade myofibroblastic sarcoma","Superficial CD34-positive fibroblastic tumor","Myxoinflammatory fibroblastic sarcoma","Fibrohistiocytic Tumors","Plexiform fibrohistiocytic tumor","Giant cell tumor of soft parts NOS","Vascular Tumors","Pericytic Tumors","Smooth Muscle Tumors","Smooth muscle tumor of uncertain malignant potential","EBV-associated smooth muscle tumor","Ossifying fibromyxoid tumor","Undifferentiated Small Round Cell Sarcomas of Bone and Soft Tissue","Well differentiated liposarcoma: lipoma-like, sclerosing, inflammatory","Dedifferentiated liposarcoma","Myxoid Liposarcoma","Pleomorphic liposarcoma","Myxoid pleomorphic liposarcoma","Solitary fibrous tumor, malignant","Low grade fibromyxoid sarcoma","Sclerosing epithelioid fibrosarcoma","Malignant tenosynovial giant cell tumor","Epithelioid hemangioendothelioma","Glomus tumor; malignant","Inflammatory leiomyosarcoma","Malignant peripheral nerve sheath tumor","Melanotic malignant nerve sheath tumor","Granular cell tumor, malignant","Perineurioma, malignant","Phosphaturic mesenchymal tumor, malignant","NTRK-rearranged spindle cell neoplasm","Epithelioid sarcoma: proximal and classic variant","Clear cell sarcoma","Extraskeletal myxoid chondrosarcoma","Perivascular epithelioid tumor, malignant","Intimal sarcoma","Ossifying fibromyxoid tumor, malignant","Myoepithelial carcinoma","Undifferentiated sarcoma","Spindle cell sarcoma, undifferentiated","Pleomorphic sarcoma, undifferentiated","Round cell sarcoma, undifferentiated","Round cell sarcoma with EWSR1-non-ETS fusions","CIC-rearranged sarcomas","Sarcoma with BCOR genetic alteration","2026-06-08",{"date":118,"type":35},"2026-06-10",{"date":120,"type":35},"2024-03-27",{"date":122,"type":19},"2037-06",{"name":124,"class":42},"St. Jude Children's Research Hospital",7,{"id":127,"slug":4,"hasResults":10,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":10,"sex":15,"minAge":132,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":20,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100518069","NCT06025747","A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for Liposarcomas","A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for High-Risk Adipocytic Retroperitoneal Sarcomas","Inclusion Criteria:\n\n* Subjects, \\>= 18 years old, must have newly diagnosed or locally recurrent MDM2 or CDK4-amplified adipocytic sarcoma as determined by fluorescence in situ hybridization (FISH), or other clinically appropriate methodology in the opinion of the reviewing pathologist. Histologic or imaging evidence of the presence of a dedifferentiated component must be present\n* Subjects must have one or more measurable target lesions by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), assessed via CT scan or MRI\n* At the time of study enrollment, subjects must have a tumor burden that is judged to be surgically resectable\n* Have plans to undergo neoadjuvant radiation therapy followed by surgical resection. Review and approval of final treatment plans for subjects receiving radiotherapy locally\u002Fat an outside institution must be reviewed and approved by a radiation oncologist investigator prior to initiation of radiotherapy\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 (\\>= 1.5 GI\u002FL) without granulocyte colony-stimulating factor support in the last 14 days (subjects may not have received blood product transfusion or granulocyte colony-stimulating factor \\[G-CSF\\] within 14 days prior to screening)\n* White blood cell count \\>= 2500\u002Fmm\\^3 (\\>= 2.5 GI\u002FL) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Platelets \\>= 100,000\u002Fmm\\^3 (\\>= 100 GI\u002FL) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Hemoglobin \\>= 8 g\u002FdL (\\>= 80 g\u002FL) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\\\u003C 3 x upper limit of normal (ULN) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (subjects with Gilbert's disease =\\\u003C 2 x ULN and direct bilirubin within normal limits are permitted) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Serum albumin \\>= 2.8 g\u002Fdl (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Serum creatinine =\\\u003C 2.0 x ULN or calculated creatinine clearance \\>= 30 mL\u002Fmin (\\>= 0.5 mL\u002Fsec) using the Cockcroft-Gault equation (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Urine protein\u002Fcreatinine ratio (UPCR) =\\\u003C 1 mg\u002Fmg (=\\\u003C 113.2 mg\u002Fmmol) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Male or non-pregnant and non-breast feeding female:\n\n  * Women of child-bearing potential (WOCBP) must agree to use highly effective contraception without interruption from initiation of therapy and continue until 4 months (120 days) after last dose of study therapy. WOCBP must have a negative serum pregnancy test (beta-human chorionic gonadotropin \\[hCG\\]) result at screening and agree to ongoing pregnancy testing during the study, and at the end of study treatment. A highly effective method of contraception is defined as one that results in a low failure rate (that is, \\\u003C 1% per year), when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner\n  * Male subjects must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study\n* Life expectancy of \\> 3 months, as determined by the investigator\n* Ability to understand and sign informed consent\n* Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) for the investigational diagnosis\n* Receipt of any prior radiation therapy for any reason to the affected area\n* Known central nervous system (CNS) metastases\n* Evidence of distant metastatic disease at time of treatment initiation\n* History of thromboembolic event within 1 year of treatment initiation. Thromboembolic events include, but are not limited to, deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis\n* History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* History of any major surgery within 14 days prior to enrollment\n* Receipt of ongoing anti-coagulation for treatment or prophylaxis of thromboembolic event in the setting of prior thromboembolic event\n* History of interstitial lung disease\n* Subjects with serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C 30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)\n* Pregnant or lactating females\n* Inability to swallow tablets\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations\n* Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized tumors deemed cured and not treated with systemic therapy\n* Concurrent use of medications (especially those interacting with CYP3A) that potentially interact unsafely with abemaciclib which cannot be discontinued or substituted\n* Recent infection requiring systemic anti-infective treatment that was completed =\\\u003C 14 days prior to enrollment (except for uncomplicated urinary tract infection or upper respiratory tract infection). Any active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening for human immunodeficiency virus (HIV)\u002Fhepatitis is not required for enrollment\n* Concurrent enrollment in any other type of medical research (for example: medical device) judged by the investigator not to be scientifically or medically compatible with this study","18 Years",{"count":134,"type":19},18,[22],"This phase I trial tests the safety, side effects, and best dose of abemaciclib and how well it works with radiation therapy before surgery in treating patients with high-risk adipocytic retroperitoneal sarcoma. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving abemaciclib together with radiation therapy before surgery may shrink tumors in patients with high-risk adipocytic retroperitoneal sarcoma.",[138,30,139],"Retroperitoneal Sarcoma","Dedifferentiated Liposarcoma",{"date":141,"type":35},"2026-06-11",{"date":143,"type":35},"2025-03-19",{"date":145,"type":19},"2029-03-03",{"name":147,"class":42},"University of Washington",1,{"id":150,"slug":4,"hasResults":10,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":10,"sex":15,"minAge":132,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":20,"phases":157,"briefSummary":158,"conditions":159,"keywords":166,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":125},"100580950","NCT06843967","A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma","A Phase Ib\u002FII Study of the Mirdametinib in Combination With Palbociclib in Patients With Advanced Dedifferentiated Liposarcoma","Inclusion Criteria:\n\nPhase I only:\n\n* A diagnosis of unresectable, recurrent, or metastatic DDLPS\n* Measurable disease as defined by RECIST 1.1\n\nPhase II only:\n\n* A diagnosis of unresectable, recurrent (e.g. recurrent retroperitoneal) or metastatic DDLPS\n* Any number of prior lines of therapy\n\n  * Measurable disease and evidence of progression of disease as defined by RECIST 1.1 (including newly diagnosed disease, new disease sites in a patient who was previously NED, or a 20% growth of existing lesions within 6 months of registration)\n  * Age ≥ 18 years\n  * ECOG performance status ≤ 2\n  * Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):\n* Absolute neutrophil count ≥ 1.5 x 109\u002FL\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Platelets ≥ 100 x 109\u002FL\n* Total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN, except patients with Gilbert's disease (≤3x ULN)\n* AST (SGOT) \u002FALT (SGPT) ≤ 1.5 x institutional ULN\n* Creatinine Clearance ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault method)\n\n  * Adequate coagulation function, as determined by:\n* International Normalized Ratio (INR) ≤ 1.5 × ULN (Grade ≤ 1). If the participant receives anticoagulant therapy, the INR \\> 1.5 × ULN is permitted but the dose must be stable for at least 2 weeks before the start of the study treatments.\n* PTT ≤ 1.5 × ULN.\n\n  * Adequate cardiac function, as determined by:\n* Systolic blood pressure \\\u003C 160 mmHg and diastolic blood pressure \\\u003C 100 mmHg (Grade ≤ 2).\n* LVEF ≥ 50% by MUGA or ECHO.\n* No clinically significant ECG waveform abnormalities assessments at screening.\n\n  * Adequate glycemic control, as determined by:\n* Fasting blood glucose level \\\u003C 125 mg\u002FdL, or\n* Random blood glucose level \\\u003C 200 mg\u002FdL.\n\n  * Have normal serum calcium and phosphate levels (calcium level may be corrected for albumin level).\n  * Have intraocular pressure ≤ 21 mmHg in both eyes\n  * Women of child-bearing potential must agree to use highly effective contraceptive methods (hormonal or barrier method of birth control or abstinence) during the trial period through at least six months after the last dose. Male patients or their partners must be surgically sterile or agree to use adequate contraception while receiving trial treatment and for three months thereafter. Acceptable methods of contraceptive use by men or women are detailed in Section 15.3.\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Ability to swallow tablets or capsules\n  * Patients with brain metastasis that have been treated with definitive surgery or radiation, and have been clinically stable for 3 months are eligible.\n\nExclusion Criteria:\n\n* Patients who have not recovered from clinically significant adverse events of prior therapy to ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to ≤ Grade 2 or baseline.\n* Patients receiving any other investigational agents.\n* Phase II only: Receipt of prior treatment with a selective CDK4 inhibitor or MEK inhibitor\n* Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including uncontrolled HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmias, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, clinically significant interstitial lung disease or active noninfectious pneumonitis, or active infection requiring systemic therapy.\n\n  * Patients with a CD4+ count of \\> 300 and an undetectable viral load who are currently on HAART are eligible for inclusion.\n  * Patients with NYHA class III or IV congestive heart failure within 6 months of study treatment will be excluded.\n  * Patients with history of clinically significant cardiac disease (New York Heart Association Class III or IV), myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, clinically significant transient ischemic attack, symptomatic pulmonary embolism, unexplained syncope, or long QT syndrome within 6 months before the start of study treatment will be excluded.\n* Pregnant women and women who are breast-feeding.\n* Prolonged QTcF \\> 470ms at Screening, irrespective of sex.\n\n  o If a single 12-lead electrocardiogram (ECG) or, for patients with prolonged QT intervals or other cardiac indications, a triplicate ECG should be performed.\n* Current Chronic Kidney Disease stage \\> 3 or Creatinine Clearance \\\u003C 60 mL\u002Fmin (calculated by Cockcroft-Gault method)\n* Current or history of Interstitial Lung Disease\n* History or current evidence of glaucoma or clinically significant abnormalities on the ophthalmological exam, including but not limited to cataract limiting the ability to examine the retina or any ophthalmological finding that could be a significant risk factor for RVO, retinopathy or neovascular macular degeneration.\n* Concurrent neuromuscular disorder that is associated with the potential of elevated CPK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).\n* Radiation therapy within 2 weeks prior to study Day 1\n* Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery.\n* Patient is receiving systemic (oral or IV\u002FSC) or ocular glucocorticoid therapy (with the exception of participants with endocrine deficiencies who are allowed to receive physiologic or stress doses of steroids, if necessary) within 14 days prior to first dose of study treatment\n* Known prior severe hypersensitivity to investigational product or any component in its formulation.\n\n  o This includes hypersensitivity to imidazoles, such as clotrimazole, ketoconazole, miconazole and others in this drug class. Subjects with hypersensitivity to these agents will be excluded from enrollment.\n* History of significant toxicity related to prior CDK4\u002F6, MEK, or ERK inhibitor requiring discontinuation of treatments with these agents.\n* Concurrent, clinically significant, active malignancies within 12 months of study enrollment\n* Current evidence of a disorder that could reduce the ability to swallow oral dosage forms or alter absorption of orally administered drugs.\n* Patients who require concomitant use of medications that strongly induce or inhibit CYP3A or UDP-glucuronosyltransferase (UGT)\n* Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1. Non-tolerable Grade 2 toxicities are defined as those with moderate symptoms that the subject is not able to endure for the conduct of instrumental activities of daily life or that persists ≥ 7 days.",{"count":156,"type":19},54,[22,23],"The purpose of this study is to find out whether mirdametinib in combination with palbociclib is an effective and safe treatment for people with metastatic, recurrent, and unresectable liposarcoma. This study will test different doses of mirdametinib in combination with a fixed dose of palbociclib to find the best safe dose for further testing.",[160,139,30,86,161,162,163,164,165],"Well Differentiated Liposarcoma","Round Cell Liposarcoma","Myxoid Pleomorphic Liposarcoma","Pleomorphic Liposarcoma","Unresectable Liposarcoma","Unresectable Dedifferentiated Liposarcoma",[160,139,30,86,161,162,163,164,165,167,168,169],"Unresectable Well Differentiated Liposarcoma","24-344","Memorial Sloan Kettering Cancer Center","2026-05-20",{"date":172,"type":35},"2026-05-22",{"date":174,"type":35},"2025-02-19",{"date":176,"type":19},"2028-08-19",{"name":169,"class":42},{"id":179,"slug":4,"hasResults":10,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":10,"sex":15,"minAge":132,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":20,"phases":187,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":200},"100364933","NCT04031677","Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma","A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)","STRASS2","1. STRASS 2\n\n   Inclusion Criteria:\n   * Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.\n   * LMS:\n\n     * Any grade LMS can be included\n     * Minimum size of LMS tumor should be 5 cm\n   * LPS:\n\n     * Diagnosis should be confirmed based on MDM2 (Mouse double minute 2 homolog) and CDK4 (Cyclin-dependent kinase 4) expression on IHC (immunohistochemistry), while proof of MDM2 amplification is highly recommended.\n     * All grade 3 DDLPS can be included.\n     * DDLPS with confirmed grade 2 on biopsy can be included when:\n\n       * The grade 2 DDLPS has an FNCLCC score=5 (Fédération Nationale des Centres de Lutte Contre Le Cancer), and clear necrosis on imaging (whether or not present on the biopsy).\n       * The tumors carry a high risk gene profile as determined by the Complexity INdex in SARComas (CINSARC-high)\n     * Unifocal tumour\n     * Resectable tumour: resectability is based on pre-operative imaging (CT-abdomen, potentially also with MRI) and has to be defined by the local treating sarcoma team. A patient is not considered resectable when the expectation is that only an R2 resection is feasible.\n     * Criteria for non-resectability are:\n     * Involvement of the superior mesenteric artery, aorta, coeliac trunk and\u002For portal vein\n     * Involvement of bone\n     * Growth into the spinal canal\n     * Progression of retro-hepatic inferior vena cava leiomyosarcoma towards the right atrium\n     * Infiltration of multiple major organs like liver, pancreas and or major vessels\n     * Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by imaging. CT thorax abdomen pelvis with IV contrast is the preferred imaging modality. In case of any contra-indications (medical or regulatory), it is allowed to perform a non-contrast CT thorax + MRI abdomen \\& pelvis\n     * Collection of tumour tissue for central pathology review is mandatory.\n     * For patients with LMS: if there is not enough tissue for assessing the grading, this is acceptable.\n     * If tumour tissue is not available for the central pathology review, patient will not be eligible.\n     * If the biopsy was not done or the FFPE of the biopsy not available but at least 10 unstained slides or one pathological block are available for the central review, that will be considered as acceptable.\n     * For the biopsy if fine needle aspiration (FNA) is performed instead of core needle biopsy (CNB) recommended by the standard guidelines, please contact the EORTC medical monitors for further evaluation.\n     * Collection of tumour tissue and blood samples for translational research is mandatory.\n     * In case there is not enough tissue for TR, a new biopsy is not required and if the patient fulfils all other eligibility criteria, he\u002Fshe will be eligible.\n     * If the blood samples are not collected, patient will not be eligible.\n     * If the patient refuses the collection of biomaterial for TR, patient will not be eligible even if he\u002Fshe fulfils all other eligibility criteria\n     * ≥ 18 years old (no upper age limit)\n     * WHO performance status ≤ 2\n     * Adequate haematological and organ function\n     * American Society of Anaesthesiologist (ASA) score \\\u003C 3\n     * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization.\n\n   Note: a woman is considered of childbearing potential, i.e., fertile, if she is following menarche. She remains of childbearing potential until she becomes post-menopausal or permanently sterile.Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n\n   A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 consecutive months without menses, a single FSH measurement is insufficient.\n   * WOCBP in both arms should use highly effective birth control measures, during the study treatment period and for at least 6 months after the last dose of chemotherapy or date of surgery (except for women receiving chemotherapy with ifosfamide who should continue contraception until 1 year after last day of treatment). A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n   * For men in the experimental arm: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.\n   * Female subjects who are breast feeding should discontinue nursing prior to the first day of study treatment and until 6months after the last study treatment.\n   * Before patient randomization, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\n   Exclusion criteria:\n   * Sarcoma originating from bone structure, abdominal or gynecological viscera\n   * Extension through the sciatic notch or across the diaphragm\n   * Metastatic disease\n   * Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour\n   * Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients\n   * Congestive heart failure\n   * Angina pectoris\n   * Myocardial infarction within 1 year before randomization\n   * Uncontrolled arterial hypertension defined as blood pressure ≥ 150\u002F100 mm Hg despite optimal medical therapy.\n\n   Note: in case of high blood pressure: 1) initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; 2) blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP \u002F DBP values from each blood pressure assessment must be ≤ 150\u002F90mmHg in order for a patient to be eligible for the study.\n   * Uncontrolled cardiac arrhythmia\n   * Previous treatment with maximum cumulative doses (450mg\u002Fm² Doxorubicin or equivalent 900mg\u002Fm² Epirubicin) of doxorubicin, daunorubicin, epirubicin, idarubicin, and\u002For other anthracyclines and anthracenediones\n   * Active and uncontrolled infections\n   * Vaccination with live vaccines within 30 days prior to study entry\n   * Inflammation of the urinary bladder (interstitial cystitis) and\u002For obstructions of the urine flow.\n   * Other invasive malignancy within 5 years, with the exception of adequately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason ≤ 6prostate cancer.\n   * Uncontrolled severe illness, infection, medical condition (including uncontrolled diabetes), other than the primary LPS or LMS of the retroperitoneum.\n   * Female patients who are pregnant or breastfeeding or female and male patients of reproductive potential who are not willing to employ effective birth control method.\n   * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial\n   * Known contraindication to imaging tracer and to MRI\n2. Selection criteria for STREXIT 2\n\n   * Patients with histologically proven primary resectable localized high-risk DDLPS or LMS of retroperitoneal space or infra-peritoneal spaces of pelvis (as described in the inclusion criteria of STRASS 2) and amenable to receive chemotherapy but for whom the list of eligibility criteria for the study is too restrictive (tumour grading not available, inadequate organ function, concomitant diseases)\n   * Patients who meet all eligibility criteria of STRASS 2 but do not consent to randomization or are not enrolled for any other reason.\n   * Patients enrolled in a Registry collecting data on primary RPS patients in the centres participating in STRASS 2 (e.g., RESAR) and who satisfy the above criteria.\n3. Selection criteria for preferences for neoadjuvant chemotherapy in STRASS 2 substudy\n\nAll patients recruited to STRASS 2 in participating centres (Australia +\u002F- international sites) that are able to read, comprehend and write in English at a sufficient level to complete study materials.",{"count":186,"type":19},250,[188],"PHASE3","This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.\n\nAfter confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.",[138,30,191],"Leiomyosarcoma",{"date":172,"type":35},{"date":194,"type":35},"2021-01-20",{"date":196,"type":19},"2028-04-21",{"name":198,"class":199},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",169,{"id":202,"slug":4,"hasResults":10,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":10,"sex":15,"minAge":207,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":20,"phases":211,"briefSummary":212,"conditions":213,"keywords":218,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":148},"100417400","NCT04715191","Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors","Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressing Autologous T Cells as an Immunotherapy for Children With Solid Tumors (CARE)","Procurement Eligibility\n\nInclusion 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 ≥1 year and ≤ 21 years\n* Lansky or Karnofsky score ≥60%\n* Life expectancy ≥16 weeks\n* Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only)\n* 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\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 (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 Eligibility\n\nInclusion Criteria:\n\n* Age ≥ 1 year and ≤ 21 years\n* Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only)\n* Lansky or Karnofsky score ≥ 60%\n* Child-Pugh-Turcotte score \\\u003C 7 (for patients with hepatocellular carcinoma only)\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 \\> 750\u002Fµl\n* Platelet count \\> 75,000\u002Fµl (Needs to be confirmed prior to treatment whether with or without transfusion)\n* Hgb ≥ 8.0 g\u002Fdl (Needs to be confirmed prior to treatment whether with or without transfusion)\n* Pulse oximetry ≥ 92% on room air\n* Incurable disease after treatment with up- front therapy (Patients who have relapsed disease despite a standard of care salvage therapy)\n* Wash out period, such that patient has recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study, and returned to their clinical baseline, 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 6 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\nExclusion 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 24 hours prior to CAR T cell infusion)\n* Known HIV positivity\n* Active bacterial, fungal or viral infection \\[except Hepatitis B (HBV patients with active disease who meet the criteria for anti-HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy) or Hepatitis C virus infections (should have completed curative antiviral treatment with HCV viral load below the limit of quantification\\]\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\n* Active autoimmune or inflammatory disorder\n* Live vaccines within 30 days prior to enrollment\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)","1 Year","21 Years",{"count":210,"type":19},24,[22],"Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called CARE T cells, a new experimental treatment.\n\nThe 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. Antibodies 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\nInvestigators have found from previous research that they can put a new gene (a tiny part of what makes-up DNA and carries a person's traits) into T cells that will make them recognize cancer cells and kill them. In the lab, investigators made several genes called a chimeric antigen receptor (CAR), from an antibody called GPC3. The antibody GPC3 recognizes a protein found solid tumors including pediatric liver cancers. This CAR is called GPC3-CAR. To make this CAR more effective, investigators also added two genes that includes IL15 and IL21, which are protein that helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 plus IL21 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL15 plus IL21 .This study will test T cells that investigators made (called genetic engineering) with GPC3-CAR and the IL15 plus IL21 (CARE T cells) in patients with GPC3-positive solid tumors.\n\nT cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. The investigators will insert the iCasp9 and IL15 plus IL21 together into the T cells using a virus that has been made for this study. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. The investigators will use this drug to kill the T cells if necessary due to side effects.\n\nThis study will test T cells genetically engineered with a GPC3-CAR and IL15 plus IL21 (CARE T cells) in patients with GPC3-positive solid tumors.\n\nThe CARE T cells are an investigational product not approved by the Food and Drug Administration.\n\nThe purpose of this study is to find the biggest dose of CARE T cells that is safe, to see how long they last in the body, to learn what the side effects are and to see if the CARE T cells will help people with GPC3-positive solid tumors.",[214,29,215,30,216,217],"Liver Cancer","Malignant Rhabdoid Tumor","Wilms Tumor","Yolk Sac Tumor",[219,220,221],"15.21.GPC3-CAR T cells","GPC3","Glypican","2026-04-01",{"date":224,"type":35},"2026-04-06",{"date":226,"type":35},"2024-05-24",{"date":228,"type":19},"2041-07-03",{"name":230,"class":42},"Baylor College of Medicine",{"id":232,"slug":4,"hasResults":10,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":10,"sex":15,"minAge":132,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":239,"phases":4,"briefSummary":240,"conditions":241,"keywords":251,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":148},"100626230","NCT07432932","Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients","PANTHR-S","Inclusion Criteria:\n\n* Written informed consent for the prospective cohort\n\n  * Histopathological diagnosis of high-risk soft tissue sarcoma and one of the following subtypes: DDLPS, LMS, SS, vascular sarcomas or MPNST. Other subtypes may be included with PI approval.\n  * High-risk sarcoma definition:\n\n    * Greater than 5cm or Grade 3\n    * Deep anatomic location\n  * Have disease amenable to biopsy\n\n    o Patients who are not amenable to repeat biopsy at baseline can be reviewed with the local site PI for consideration of inclusion to the study\n  * Resectable tumour\n  * Measurable disease by RECIST 1.1\n  * Aged ≥ 18 years\n  * WHO performance status 0-2\n  * For patients receiving NCT, medically fit enough, with adequate organ function, to undergo neoadjuvant chemotherapy\n  * Patients medically fit enough to undergo surgical resection\n  * Capable of giving written informed consent (for prospective cohort) and comply with the study schedule\n  * Patients may also participate in the STRASS 2 trial\n\nExclusion Criteria:\n\n-Prior invasive malignancy in last 5 years, low risk malignancies in the last 5 years may be reviewed by the PI.\n\n* Known additional malignancy that is progressing or requires active treatment\n* Metastatic disease not amenable to curative intent local therapy\n* Any active uncontrolled medical conditions",{"count":238,"type":19},800,"OBSERVATIONAL","This is a cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT) in high-risk soft tissue sarcoma (STS) patients with dedifferentiated liposarcoma (DDLPS), leiomyosarcoma (LMS), synovial sarcoma (SS), vascular sarcomas, malignant peripheral nerve sheath tumour (MPNST) or other subtypes. It comprises of both retrospective and prospective tissue collection from patients advancing directly to surgery (control group) and patients receiving NCT and surgery.",[242,243,244,245,246,247,248,138,249,30,250,60],"Sarcoma","Sarcoma, Leiomyo-, Adult","Sarcoma, Synovial, Adult","Soft Tissue Sarcoma (STS)","Soft Tissue Sarcoma Adult","Soft Tissue Sarcoma of the Trunk and Extremities","Soft Tissue Sarcoma of the Limb","Liposarcoma, Dedifferentiated","Leiomyosarcoma (LMS)",[252,253,254],"PANTHRS","PANTHRS-S","Sarcoma Accelerator","2026-02-18",{"date":257,"type":35},"2026-02-25",{"date":259,"type":35},"2021-11-19",{"date":261,"type":19},"2028-06-30",{"name":263,"class":42},"Royal Marsden NHS Foundation Trust",{"id":265,"slug":4,"hasResults":10,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":10,"sex":15,"minAge":207,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":20,"phases":273,"briefSummary":274,"conditions":275,"keywords":281,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":148},"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":272,"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.",[276,277,215,217,30,29,278,216,279,280],"Solid Tumor (Excluding CNS)","Liver Cell Carcinoma","Embryonal Sarcoma of Liver","Hepatocellular Carcinoma","Hepatoblastoma",[282,283,284,285,214,286,220,221],"CAR T cell","Pediatric","Young Adult","Non-CNS Tumor","Solid Tumor","2026-02-13",{"date":289,"type":35},"2026-02-17",{"date":291,"type":35},"2025-12-22",{"date":293,"type":19},"2044-04-22",{"name":295,"class":42},"Seattle Children's Hospital",{"id":297,"slug":4,"hasResults":10,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":10,"sex":15,"minAge":132,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":20,"phases":305,"briefSummary":306,"conditions":307,"keywords":313,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":321,"leadSponsor":322,"locationsCount":324},"100605961","NCT07169344","Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma","PROSARC-1. Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.","PROSARC-1","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of informed consent.\n2. Histological diagnosis of STS, except rhabdomyosarcoma and Ewing sarcoma. Pleomorphic rhabdomyosarcomas are eligible.\n3. Primary tumor localized in head, neck, extremity, girdle and\u002For trunk wall.\n4. Measurable disease according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n6. Before patient registration, written informed consent must be given according to national and local regulations.\n7. Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for PBT.\n\nExclusion Criteria:\n\n1. Locoregional or distant metastasis as assessed by CT and\u002For MRI at time of diagnosis. Patients with lung nodules \\\u003C10 mm of uncertain etiology may be included.\n2. Prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may be included. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may be included.\n3. Previous radiotherapy to the primary tumor region.\n4. Patients with pacemakers and\u002For implanted defibrillators.\n5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.\n6. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.",{"count":304,"type":19},110,[23],"The purpose of the study is to investigate whether a personalized selection of patients with localized soft tissue sarcoma for preoperative proton radiation therapy can reduce long-term radiation side effects without increasing surgical complications or reducing the effectiveness of the treatment. Two radiation plans will be created for each patient-one for protons and one for photons-and through a national meeting, we will determine which type of radiation therapy each patient will receive. The radiation dose will be the same for both photons and protons.\n\nThe primary endpoint is surgical complications 120 days after surgery. Secondary endpoints include overall survival, local recurrence-free survival, disease-free survival, side effects, and quality of life. Furthermore, the study will investigate biomarkers that may predict response to radiation therapy, including changes in the tumor's genetic material (DNA), measurement of various molecules in the bloodstream, and the tumor's appearance on MRI scans.\n\nThe study will be conducted in Norway, with a planned inclusion of 110 patients.",[308,246,247,309,191,310,311,30,312],"Soft Tissue Sarcoma (Excluding GIST)","Synovial Sarcomas","Undifferentiated Pleomorphic Sarcoma (UPS)","Myxofibrosarcoma (MFS)","Pleomorphic Rhabdomyosarcoma",[65,314,315,316],"proton radiotherapy","x-ray radiotherapy","surgical complications","2026-01-26",{"date":319,"type":35},"2026-01-28",{"date":317,"type":35},{"date":39,"type":19},{"name":323,"class":42},"Oslo University Hospital",4,{"id":326,"slug":4,"hasResults":10,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":10,"sex":15,"minAge":132,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":20,"phases":334,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":342,"leadSponsor":343,"locationsCount":344},"100606316","NCT07173972","Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.","PROSARC-2. Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.","PROSARC-2","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of informed consent.\n2. Histological diagnosis of soft tissue sarcoma including gastrointestinal stromal tumor (GIST).\n3. Measurable disease according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n5. For patients with metastatic disease a life-expectancy greater than 2 years should be expected.\n6. Before patient registration, written informed consent must be given according to national and local regulations.\n7. Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for Proton Beam radiotherapy.\n\nExclusion Criteria:\n\n1. Patients with a prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may be included. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may be included.\n2. Previous radiotherapy to the tumor site.\n3. Patients with pacemakers and\u002For implanted defibrillators.\n4. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.\n5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.",{"count":333,"type":19},40,[23],"The purpose of the study is to study if dose escalated proton radiotherapy can improve local controll for patients with inoperable soft tissue sarcomas. The standard treatment is photon-based radiation. By using proton radiotherapy instead, the hypothesis is that the dose can be increased to enhance treatment effectiveness without increasing side effects.\n\nThe planned radiation dose is 56 Gy in 16 fractions (treatments) over 4 weeks (4 fractions per week), with a maximum dose escalation centrally in the tumor up to 80 Gy (5 Gy per fraction).\n\nAt the same time, the study will investigate biomarkers that can predict treatment response, including changes in the tumor's genetic material (DNA), measurements of various molecules in the bloodstream, and the tumor's appearance on MRI scans.\n\nThe primary endpoint is local control after 2 years, meaning that the treated tumor has not grown during this period. Secondary endpoints include overall survival, progression-free survival, radiological response rates, side effects, and quality of life.\n\nThe study will be conducted in Norway, with a planned inclusion of 40 patients.",[245,246,247,309,310,59,250,163,312,30],[338,314,339],"soft tissue sarcoma","inoperable soft tissue sarcoma",{"date":319,"type":35},{"date":317,"type":35},{"date":39,"type":19},{"name":323,"class":42},2,{"id":346,"slug":4,"hasResults":10,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":10,"sex":15,"minAge":208,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":20,"phases":353,"briefSummary":354,"conditions":355,"keywords":356,"overallStatus":358,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":363,"leadSponsor":365,"locationsCount":148},"100610206","NCT07224568","Cytokine Armored GPC3 Specific Chimeric Antigen Receptor Expressing T-cells in Adults With Solid Tumors","INTERCEPT-GPC3: Interleukin-15 and -21 Armored Glypican-3 Specific Chimeric Antigen Receptor Expressing Autologous T-cells in Adults With GPC3-positive Solid Tumors","INTERCEPT","1. Procurement Eligibility\n\n   Inclusion Criteria:\n   * Diagnosis of a solid tumor expressing GPC3\n   * Karnofsky score of \\>=60%\n   * Life expectancy of \\>16 weeks\n   * Informed consent explained to, understood by and signed by participant or participant's legally authorized representative\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* 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 3 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 bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* Pregnancy or lactation\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)",{"count":272,"type":19},[22],"This Phase 1, open-label, non-randomized study will enroll 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\nAn adult participant 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.",[276,279,277,30,217,29],[282,357,285,214,286,220,221],"Adult","NOT_YET_RECRUITING","2025-10-31",{"date":361,"type":35},"2025-11-04",{"date":222,"type":19},{"date":364,"type":19},"2045-08",{"name":295,"class":42},{"id":367,"slug":4,"hasResults":10,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":208,"enrollmentInfo":372,"targetDuration":4,"studyType":20,"phases":373,"briefSummary":374,"conditions":375,"keywords":376,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":148},"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":272,"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.",[280,279,216,215,217,29,30,278],[377,378],"GPC3-positive tumors","GPC3-CAR T cells","2025-10-30",{"date":381,"type":35},"2025-11-03",{"date":383,"type":35},"2025-06-10",{"date":385,"type":19},"2043-02-01",{"name":230,"class":42},{"id":388,"slug":4,"hasResults":10,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":10,"sex":15,"minAge":132,"maxAge":393,"enrollmentInfo":394,"targetDuration":4,"studyType":20,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":148},"100537386","NCT06277154","MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma","A Phase II Study Evaluating the Safety and Efficacy of MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment in Patients With Advanced Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Age≥18 years and≤70 years;\n2. According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor.\n3. No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy.\n4. At least one measurable and assessable lesion defined by RECIST 1.1;\n5. ECOG performance status of 0-1;\n6. Estimated life expectancy≥6 months;\n7. Pulmonary function is basically normal;\n8. Subjects with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis): a) Hemoglobin ≥90g\u002FL; b) Leukocyte≥3.5x10\\^9\u002FL; c) The absolute neutrophil count (ANC)\\>1.5x10\\^9\u002FL; d) Platelet≥100x10\\^9\u002FL; e) ALT, AST≤2.5 ULN (Upper Limit of Normal), ALT, AST≤5 ULN for liver metastases; f) ALP≤2.5 ULN; g) Serum total bilirubin≤1.5 ULN; Patients with Gilbert's syndromes (persistent or repeated hyperbilirubinemia \\[mainly unconjugated bilirubin\\], in the absence of evidence of hemolysis or liver disease), are allowed to enroll with investigator's agreement; h) Serum urea nitrogen or urea and creatinine≤2.5 ULN; i) Serum albumin≥35g\u002FL; j) PT, APTT, INR≤1.5 ULN (without anticoagulation treatment);\n9. Obtain the written informed consent of the patient\u002Flegal representative;\n10. Subjects with potential fertility must agree to use effective contraceptive measure during and within 6 months after the treatment period. HCG test for female with potential fertility must be negative before the study was included.\n\nExclusion Criteria:\n\n1. Previous treatment with targeted therapy, radiotherapy (radiotherapy to non-target lesions or disease progressed after radiotherapy could be included.) or other antineoplastic drugs such as anlotinib, gemcitabine, within 4 weeks before randomization, or have received Chinese medicine or proprietary Chinese medicine for anti-tumor treatment within 2 weeks before randomization.\n2. Highly differentiated liposarcoma, malignant perivascular epithelioid tumor, protuberant cutaneous fibrosarcoma, extraosseous osteosarcoma, solitary fibroma\u002Fhemangiopericytoma, acinous soft tissue sarcoma, extraosseous myxoid chondrosarcoma, gastrointestinal stromal tumor, invasive fibroma, renal angiomyolipoma, malignant mesothelioma, clear cell sarcoma, Ewing's sarcoma, etc., which are not suitable for Doxorubicin+ Ifosfamide (AI) treatment.\n3. Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg\u002Fm2 doxorubicin.\n4. Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.\n5. Use of immunosuppressive agents or systemic or inhaled local hormones (exceeding 10mg\u002Fday prednisone or its equivalent) and were still using them within 2 weeks before randomization.\n6. Use of immunomodulators and were still using them within 2 weeks before randomization.\n7. Allergic to sodium citrate or human albumin.\n8. Subjects with uncontrolled pleural effusion and abdominal effusion requiring repeated drainage and with moderate or higher volume of pericardial effusion.\n9. Have known active central nervous system (CNS) or meningeal metastases. Subjects with previously treated brain metastases may participate provided they are stable based on the following: 1) any neurologic symptoms have returned to baseline at least 2 weeks before randomization, 2) no requirement for steroids at least 2 weeks before randomization or receiving low-dose of steroids (Not exceeding 10mg\u002Fday prednisone or its equivalent).\n10. Have any active autoimmune disease or history of autoimmune disease.\n11. Subjects with active tuberculosis.\n12. Subjects were infected with hepatitis B virus, hepatitis C virus or HIV, or syphilis.\n13. Severe cardiovascular disease, such as: (1) complete left bundle branch block or III atrioventricular block; (2) history of myocardial infarction, angioplasty, coronary artery bypass graft; (3) prolonged QT\u002FQTc interval at baseline (male\\>450ms, female \\>480ms); (4) LVEF≤50%; (5) heart failure of NYHA class 2 or higher; (6) poorly controlled hypertension (BP≥150\u002F95 mmHg, despite optimal medical treatment); (7) cardiomyopathy or severe arrhythmia and may have impact on the study based on investigator's judgement.\n14. Subjects with history of thrombus or experienced a cerebrovascular accident within 6 months before randomization;\n15. Other malignant tumors (except cured skin basal cell carcinoma, prostate carcinoma in situ and cervical carcinoma in situ) in the past 5 years;\n16. Known history of organ transplantation or ready to receive an organ transplantation;\n17. Subjects who have undergone major surgery or traumatic injury within 4 weeks before randomization;\n18. Those who have a history of alcohol dependence, psychotropic substance abuse and cannot abstain or have mental disorders.\n19. Surgery for soft tissue sarcoma is planned during the study.\n20. Subjects have participated in another investigational trial within 4 weeks before randomization.\n21. Any condition that the investigator considers to be prejudicial to the subject or to the subject's inability to meet or perform the study requirements exists.","70 Years",{"count":395,"type":19},148,[23],"This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.",[191,30,399,60,400,401,402,403,312,404,405],"Synovial Sarcoma","Undifferentiated Pleomorphic Sarcoma","Epithelioid Sarcoma","Malignant Peripheral Nerve Sheath Tumors","Fibrosarcoma","Endometrial Stromal Sarcoma","Desmoplastic Small Round Cell Tumor","2025-07-20",{"date":408,"type":35},"2025-07-24",{"date":410,"type":35},"2024-02-21",{"date":412,"type":19},"2027-02",{"name":414,"class":415},"HRYZ Biotech Co.","INDUSTRY",{"id":417,"slug":4,"hasResults":10,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":10,"sex":15,"minAge":132,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":20,"phases":424,"briefSummary":425,"conditions":426,"keywords":428,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":441},"100422773","NCT04785196","APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors","A Phase Ib\u002FII Study of APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Other Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or non-pregnant, non-lactating female patients age ≥18 years on day of signing the informed consent;\n2. ECOG PS 0-1;\n3. Phase Ib: Histologically confirmed, advanced liposarcoma or advanced solid tumor patients who failed standard of care therapy; Phase II: Histologically confirmed, advanced liposarcoma with TP53 wide-type and MDM2 Amplification;\n4. The expected survival period is more than 12 weeks;\n5. Measurable disease on CT or MRI by RECIST 1.1.\n6. Adequate bone marrow and organ function as indicated by: the following laboratory values without continuous supportive treatment (such as blood transfusion, coagulation factors and\u002For platelet infusion, red\u002Fwhite blood cell growth factor administration, or albumin infusion)\n\n   1. ANC≥1.5 x 10\\^9\u002F L;\n   2. PLT≥100 x 10\\^9\u002F L;\n   3. Hgb≥90 g\u002FL;\n   4. Alb≥30 g\u002FL;\n   5. AST and AST ≤3 \\* ULN (for hepatic metastases, ALT and AST≤5\\*ULN);\n   6. Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 50ml \u002F min.\n\nExclusion Criteria:\n\n1. Patients who have previously been treated with MDM2-p53 inhibitor;\n2. Known hypersensitivity reaction to PD-(L)1 inhibitors, or any prior ≥ Grade 3 irAE;\n3. Prior treatment consisted of any kinds of immunotherapies, like PD-(L)1 inhibitors, anti-PD-L2 antibodies, CTLA-4, OX-40 et.al( for phase II);\n4. Has known active central nervous (CNS) metastases and\u002For carcinomatous meningitis;\n5. Has any active or history of autoimmune disease;\n6. Active infection or unexplained fever \\> 38.5 ° C two weeks before first dose;\n7. Patients with any severe and\u002For uncontrolled diseases, including: hypertension and uncontrollable levels of normal anti-hypertensive medication; clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina, or coronary artery bypass surgery, congestive heart failure (New York Heart Association (NYHA) ) \\> 2);active or uncontrolled serious infection (≥CTCAE 5.0 Level 2 infection);objective evidence of previous or current history of pulmonary disease; moderate to severe hepatic impairment (Child-Pugh score ≥ 10 points); moderate to severe renal impairment or psychiatric illness\u002Fsocial circumstances that may affect study compliance;\n8. Poorly controlled arrhythmia (including QTc interval ≥450 ms for males and ≥470 ms for females).",{"count":423,"type":19},95,[22,23],"Part 1 is a phase Ib standard \"3 + 3\" design, will be employed to determine the MTD of APG-115 by assessing the DLT of APG-115 in combination with PD-1 inhibitor(toripalimab) in advanced solid tumors.\n\nPart 2 is a Simon two-stage phase II study design. At RP2D of APG-115 in combination with toripalimab in advanced liposarcoma, approximately 34 patients will be treated with the combination until disease progression, unacceptable toxicity, or another discontinuation criterion is met.",[30,427],"Advanced Solid Tumor",[429,430,30,431],"APG-115","Toripalimab","Advanced solid tumors","2025-02-24",{"date":434,"type":35},"2025-02-26",{"date":436,"type":35},"2021-05-26",{"date":438,"type":19},"2027-01",{"name":440,"class":415},"Ascentage Pharma Group Inc.",3,{"id":443,"slug":4,"hasResults":10,"nctId":444,"briefTitle":445,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":448,"sex":15,"minAge":132,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":20,"phases":451,"briefSummary":453,"conditions":454,"keywords":456,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":148},"100379706","NCT04224064","Identification of a New Blood Biomarker for the Diagnosis and Prognosis of Liposarcomas","ESPACE","Inclusion Criteria for LPS patients cohort:\n\nMen\u002Fwomen older than 18 years old,\n\nSurgery for :\n\n* Localized WD-LPS and DD-LPS, and\u002For\n* WD-LPS or DD-LPS local relapse, and\u002For\n* WD-LPS or DD-LPS distant relapse and\u002For\n* Deep adipocytic tumor greater than 5 cms, suggestive of atypical lipomatous tumor Patient accepting blood sample, Patient who signed informed consent\n\nInclusion Criteria for healthy subjects cohort:\n\nMen\u002Fwomen older than 18 years old, Accepting blood sample, Who signed informed consent Matching on sex and age on LPS patient cohort\n\nExclusion Criteria:\n\nPresence of NeoAdjuvant Treatment for the present cancer, Unaffiliated patient to French Social Protection System, Patient whose follow up is impossible for psychologic, social, geographic, familial reasons Psychiatric illness that would prevent the patient from giving informed consent or being compliant with the study procedures Patient who have another cancer within the 5 years of the inclusion except in situ breast carcinoma, in situ, basocellular carcinoma.\n\nPregnancy and\u002For feeding",true,{"count":450,"type":19},158,[452],"NA","The main objective of this project is to identify a new non-invasive biological test for the diagnosis of LPS by measuring circulating serine levels. The current gold standard is the detection of Mdm2 amplification by the FISH.",[30,455],"Atypical Lipomatous Tumor",[30,457,455,458],"Cancer","New non-invasive biological test","2025-02-11",{"date":461,"type":35},"2025-02-12",{"date":463,"type":35},"2020-08-26",{"date":465,"type":19},"2029-12",{"name":467,"class":42},"Institut du Cancer de Montpellier - Val d'Aurelle",{"id":469,"slug":4,"hasResults":10,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":10,"sex":15,"minAge":132,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":239,"phases":4,"briefSummary":476,"conditions":477,"keywords":478,"overallStatus":358,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":148},"100519092","NCT06039046","Investigating Engagement Patterns and Participation Trends Among Liposarcoma Patients","Inside Liposarcoma Clinical Trials: Patient Experiences Shared While Undergoing Clinical Trials","Inclusion Criteria:\n\n* Patient has self-identified as planning to enroll in a clinical research\n* Patient has been diagnosed with liposarcoma\n* Patient is a minimum of 18 years or older\n\nExclusion Criteria:\n\n* Patient does not understand, sign, and return consent form\n* Inability to perform regular electronic reporting\n* Patient is pregnant",{"count":475,"type":19},500,"The study seeks to delve into the firsthand experiences of patients diagnosed with liposarcoma who partake in a separate clinical research featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.\n\nBy joining this clinical study, individuals have the unique opportunity to contribute to the betterment of future liposarcoma patients and play an active role in advancing medical research.",[30],[30],"2023-09-08",{"date":481,"type":35},"2023-09-15",{"date":483,"type":19},"2024-10",{"date":485,"type":19},"2026-10",{"name":487,"class":415},"Power Life Sciences Inc.",{"id":489,"slug":4,"hasResults":10,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":10,"sex":15,"minAge":132,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":20,"phases":497,"briefSummary":498,"conditions":499,"keywords":502,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":5},"100230260","NCT02275286","Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients","Phase I-II Prospective Trial, Multicenter, Open Label, Exploring the Combination of Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients","TRASTS","Cohort A: STS\n\nInclusion Criteria:\n\n1. The patient must sign voluntarily the informed consent form before any study test is conducted that is not part of routine patient care.\n2. Aged equal or over 18.\n3. Patients must have a diagnostic of Soft Tissue Sarcoma with metastasis limited to lung, and not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy.A centralized diagnostic will be performed, the tumor sample must be available and sent prior to inclusion.\n4. Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point.\n5. Metastatic spread could be present in two organs at maximum (i.e. lungs and pelvic fosa).\n6. Those lesions considered for radiation therapy have to be considered as target lesions as well. (i.e. in a patient with nodules in lungs, those lesions selected for radiation therapy have to include at least the target lesions)\n7. It is allowed that not all the lesions will be under radiation fields. As a general rule, it will be prioritized to select, as target-irradiating lesions, those with greater increase in size and those largest lesions. It should be discouraged to irradiate pulmonary lesions with infiltration of pleural serosa.\n8. Patients must have documentation of disease progression within 6 months prior to study entry.\n9. The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced\u002Fmetastatic disease are allowed as long as trabectedin has not been included.\n10. The following histological subtypes can be included:\n\n    Undifferentiated pleomorphic sarcoma (previously, malignant fibrous histiocytoma) Leiomyosarcoma Angiosarcoma\u002F epithelial hemangioendothelioma Liposarcoma and its variants (well differentiated, dedifferentiated, myxoid\u002Fround cells, pleomorphic).\n\n    Synovial sarcoma Fibrosarcoma and its variants (epithelial fibrosarcoma\u002Flow grade fibromyxoid sarcoma) Hemangiopericytoma\u002Fsolitary fibroid tumor Neurogenic sarcoma (Malignant peripheral nerve sheath tumor, MPNST) Myxofibrosarcoma Epithelioid Sarcoma Unclassified sarcoma (spindle cell\u002Fepithelioid\u002Fpleomorphic\u002Fmyxoid)\n11. Measurable disease, according to RECIST V 1.1 criteria\n12. Performance status ≤1 (ECOG).\n13. Adequate respiratory functions: FEV1 \\>1L; DLco \\> 40% (patients with pulmonary target lesions)\n14. Adequate bone marrow function (hemoglobin \\> 10 g\u002Fdl, leukocytes ≥ 3.000\u002Fmm3, neutrophils ≥ 1.500\u002Fmm3, platelets ≥ 100.000\u002Fmm3). Patients with plasma creatinine ≤ 1,6 mg\u002Fdl, transaminases ≤ 2.5 times the UNL, total bilirubin ≤ UNL, CPK ≤ 2.5 times UNL, alkaline phosphatase ≤ 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is \\> 2.5 times the UNL, then the alkaline phosphatase liver fraction and\u002For GGT must be ≤ UNL.\n15. Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.\n16. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n17. It should be performed HBV and HCV serologies prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study)\n18. Patient must have a Central Venous Catheter for treatment\n\nExclusion Criteria:\n\n1. Previous treatment with trabectedin or previous treatment with radiotherapy (except if previous radiotherapy treatment plus planned study radiotherapy treatment allow tissues constrains)\n2. Performance status ≥ 2 (ECOG).\n3. Plasma bilirubin \\> UNL.\n4. Creatinine \\> 1.6 mg\u002FdL.\n5. History of other neoplastic disease with less than 5 years free of disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.\n6. Severe COPD or other severe pulmonary diseases.\n7. Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA)\n8. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.\n9. Uncontrolled bacterial, mycotic or viral infections.\n10. Known positive test for infection by human immunodeficiency virus (HIV).\n11. Women who are pregnant or breast-feeding.\n12. Psychological, familial, social or geographic circumstances that limit the patient\"s ability to comply with the protocol or informed consent.\n13. Patients participating in another clinical trial or receiving any other investigational product\n14. Patients who had participated in another clinical trial and\u002For had received any other investigational product in the last 30 days prior to inclusion.\n15. Histologies other than those described in inclusion criteria.\n\nCohort B: ML\n\nInclusion criteria:\n\n1. The patient must sign voluntarily the informed consent form before any study test is conducted that is not part of routine patient care.\n2. Age ≥18 years old.\n3. Pathological diagnosis of Myxoid Liposarcoma, deep located and more than 5 cm or superficial more than 10 cm. A centralized diagnostic will be performed to confirm that the patient can be included in the study.\n4. Tumor must be resectable and without evidence of regional or distal spread after adequate staging procedure. Tumor must be located in limbs or superficial trunk wall.\n5. Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point.\n6. Measurable disease, according to RECIST V 1.1 criteria\n7. Performance status 0-1 (ECOG).\n8. Adequate bone marrow function (hemoglobin \\> 10 g\u002FdL, leukocytes ≥ 3.000\u002Fmm3, neutrophils ≥ 1.500\u002Fmm3, platelets ≥ 100.000\u002Fmm3). Patients with plasma creatinine ≤ 1,6 mg\u002FdL, transaminases ≤ 2.5 times the UNL, total bilirubin ≤ UNL, CPK ≤ 2.5 times UNL, alkaline phosphatase ≤ 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is \\> 2.5 times the UNL, then the alkaline phosphatase liver fraction and\u002For GGT must be ≤ UNL.\n9. Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.\n10. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n11. It should be performed HBV and HCV serologies prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA HBV+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).\n12. Patient may have had one previous chemotherapy line.\n13. Patient must have a Central Venous Catheter for treatment.\n\nExclusion criteria:\n\n1. Unresectable tumors (with limb sparing surgery)\n2. More than one previous chemotherapy treatment for local disease including trabectedin.\n3. Radiotherapy involving the tumoral bed.\n4. Performance status ≥ 2 (ECOG).\n5. Presence of metastases or lymph node involvement by the tumor.\n6. Location other than limb or superficial trunk wall.\n7. Plasma bilirubin \\> UNL.\n8. Creatinine \\> 1.6 mg\u002FdL.\n9. History of other neoplastic disease with less than 5 years free of disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.\n10. Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA)\n11. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.\n12. Uncontrolled bacterial, mycotic or viral infections.\n13. Known positive test for infection by human immunodeficiency virus (HIV).\n14. Women who are pregnant or breast-feeding.\n15. Psychological, familial, social or geographic circumstances that limit the patient\"s ability to comply with the protocol or informed consent.\n16. Patients who had participated in another clinical trial and\u002For had received any other investigational product in the last 30 days prior to inclusion.\n\nCohorts C and D: Retroperitoneum sarcoma\n\nInclusion criteria:\n\n1. The patient must voluntarily sign the informed consent form before performing any study-specific test that is not part of the patient's usual care.\n2. Aged between 18 and 75 years.\n3. The following histological subtypes may be included in the cohort C:\n\n   High grade leiomyosarcoma (G2-3), liposarcoma (G2-3), if at least 30% of the tumour is dedifferentiated, pleomorphic liposarcoma.\n\n   The following histological subtypes may be included in the cohort D:\n\n   Well differentiated liposarcoma (WD liposarcoma) and G2 dedifferentiated liposarcorcoma, if less than 30% of the tumour is dedifferentiated.\n\n   A centralised diagnosis will be made to confirm that the patient can be included in the study.\n4. The tumour must be located in the retroperitoneum and it must be resectable and without evidence of regional or distal spread after the appropriate staging process. This point must be confirmed by the central surgeon reviewer.\n5. The location and size of the disease in the retroperitoneum must allow for compliance with radiotherapy limitations in healthy tissue. This point must be confirmed by the site's radiation oncologist and the central radiation oncologist reviewer.\n6. Measurable disease according to CHOI criteria for cohort C and RECIST V 1.1 criteria for cohort D.\n7. ECOG performance status 0-1.\n8. Adequate haematological parameters (haemoglobin \\>10 g\u002Fdl, leukocytes ≥3,000\u002Fmm3, neutrophils ≥1,500\u002Fmm3, platelets ≥100,000\u002Fmm3). Patients with plasma creatinine ≤1.6 mg\u002Fdl, transaminases ≤2.5 times the ULN, total bilirubin ≤ ULN, CPK ≤2.5 times ULN, alkaline phosphatase ≤2.5 times ULN are acceptable. If the increase in alkaline phosphatase is \\>2.5 times the ULN, the liver fraction of alkaline phosphatase and\u002For GGT should be ≤ULN.\n9. Fertile men or women must use an effective contraceptive method before starting the study, during the study and for 6 months following the conclusion thereof. Women of childbearing potential who participate in the study must undergo a pregnancy test before starting the study.\n10. Normal cardiac function with LVEF ≥50% by echocardiogram or MUGA.\n11. HBV and HCV serology must be performed before including the patient in the study. If HbsAg is positive, it is advisable to rule out a replicative phase (HbsAg\\*, DNA HBV+). If positive, the patient's inclusion in the trial is not recommended, and it is at the discretion of the investigator to administer preventive treatment with lamivudine. If a potential patient is positive to anti-HCV antibodies, the presence of the virus will be ruled out with a qualitative PCR, or the patient cannot be included in the study (if the qualitative PCR test cannot be performed on the patient, they cannot be included in the study).\n12. Patient may have had one previous chemotherapy line (cohort D only).\n13. The patient must have a central venous catheter for the administration of the treatment.\n\nExclusion criteria\n\n1. Unresectable tumours.\n2. Location other than the retroperitoneum.\n3. Patients who have previously received systemic treatment with chemotherapy (trabectedin included). For cohort D, patients may have received one previous line of chemotherapy with any other agent.\n4. Patients who underwent prior local treatment for retroperitoneal sarcoma: surgery or radiotherapy in the tumour bed.\n5. ECOG performance status ≥2.\n6. Presence of metastasis or lymph node involvement of the tumour.\n7. Previous history of another neoplastic disease with less than 5 years free of disease except for basal cell carcinoma or properly treated in situ cervical cancer.\n8. Significant cardiovascular disease (e.g. dyspnoea \\>2 NYHA).\n9. A significant grade 3 or greater systemic disease on the NCI-CTCAE v4.03 scale, which may limit the availability of the patient or which, in the opinion of the investigator, may contribute to the toxicity caused by the study treatment.\n10. Uncontrolled viral, mycotic or bacterial infections.\n11. Known HIV-positive patients.\n12. Pregnant or breast-feeding women.\n13. Psychological, familial, social or geographical circumstances that limit the patient's ability to comply with the protocol or informed consent form.\n14. Patients who have participated in another clinical trial and\u002For have received another investigational product in the 30 days prior to inclusion in the trial.",{"count":496,"type":19},199,[22,23],"Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response measure in four cohorts of patients:\n\nCohort A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma.\n\nCohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Cohort C: Patients with retroperitoneal and resectable soft tissue sarcoma (liposarcoma and leiomyosarcoma).\n\nCohort D (Phase II only): Patients with well differentiated liposarcoma and G2 dedifferentiated liposarcoma (with less than 30% dedifferentiated component).\n\nPhase I: escalating dose of 1.3 or 1.5 mg\u002Fm2. Phase I for cohort C: de-escalating dose of 1.5 or 1.3mg\u002Fm2 Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy\u002Ffraction). Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy\u002Ffraction). Radiotherapy for cohort C: 45Gy in 25 fractions (1.8Gy\u002Ffraction).\n\nRadiotherapy for cohort D: 45Gy in 25 fractions (1.8Gy\u002Ffraction). A translational substudy is developed to analyse different biomarkers predictive value.\n\nCohorts A and B are closed to recruitment in 2023.",[500,501,191,30,163],"Liposarcoma, Myxoid","Sarcoma, Soft Tissue",[503],"sarcoma","2023-05-29",{"date":506,"type":35},"2023-05-31",{"date":508,"type":35},"2014-11",{"date":510,"type":19},"2028-06",{"name":512,"class":42},"Grupo Espanol de Investigacion en Sarcomas",""]