[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"angiosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:angiosarcoma":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,102,149,233,269,316,351,383,422,444,471,508],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100534472","phase-1-nrsts2021-a-risk-adapted-study-evaluating-maintenance-pazopanib-limited-margin-dose-escalated-radiation-therapy-and-selinexor-in-non-rhabdomyosarcoma-soft-tissue-sarcoma-nrsts-100534472",false,"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.","ALL","30 Years",{"count":18,"type":19},139,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","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.",[26,27,28,29,30,31,32,33,34],"Adipocytic Neoplasm","Liposarcoma","Atypical Fibroxanthoma","Angiomatoid Fibrous Histiocytoma","Myoepithelioma","Fibrosarcoma NOS","Myxofibrosarcoma","Angiosarcoma","Osteosarcoma, Extraskeletal",[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"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","RECRUITING","2026-06-08",{"date":92,"type":93},"2026-06-10","ACTUAL",{"date":95,"type":93},"2024-03-27",{"date":97,"type":19},"2037-06",{"name":99,"class":100},"St. Jude Children's Research Hospital","OTHER",7,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":20,"phases":113,"briefSummary":114,"conditions":115,"keywords":126,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100136130","phase-2-i-spy-trial-neoadjuvant-and-personalized-adaptive-novel-agents-to-treat-breast-cancer-100136130","NCT01042379","I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer","I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)","I-SPY","Inclusion Criteria:\n\n* Histologically confirmed invasive cancer of the breast\n* Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)\n* No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed\n* Age ≥18 years\n* ECOG performance status 0-1\n* Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers\n* Non-pregnant and non-lactating\n* No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.\n* Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)\n* Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis\n* Any tumor ER\u002FPgR status, any HER-2\u002Fneu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F\n* Normal organ and marrow function: Leukocytes ≥ 3000\u002FμL, Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 100,000\u002FμL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)\u002FALT (SGPT) ≤ 1.5 x institutional ULN, creatinine \\\u003C 1.5 x institutional ULN\n* No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%\n* No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase\n* Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (\\\u003C5%), any HER2 status, or MammaPrint Low, ER positive, HER2\u002Fneu positive by any one of the three methods used (IHC, FISH, TargetPrint™)\n* Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)\n\nExclusion Criteria:\n\n* Use of any other investigational agents within 30 days of starting study treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.\n* Uncontrolled 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","18 Years",{"count":112,"type":19},5000,[23],"The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.",[116,117,118,33,119,120,121,122,123,124,125],"Breast Neoplasms","Breast Cancer","Breast Tumors","TNBC - Triple-Negative Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","Hormone Receptor Positive Tumor","Hormone Receptor Negative Tumor","Early-stage Breast Cancer","Locally Advanced Breast Cancer",[127,128,129,130,131,132,133,134,135,136,137,138],"Neoadjuvant","Breast","Cancer","Neoplasm","Adaptive","pCR","Pathologic Complete Response","Biomarkers signature","MRI Volume","Endocrine Therapy","Chemotherapy","Immunotherapy","2026-05-04",{"date":141,"type":93},"2026-05-06",{"date":143,"type":93},"2010-03-01",{"date":145,"type":19},"2031-12",{"name":147,"class":100},"QuantumLeap Healthcare Collaborative",42,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":20,"phases":159,"briefSummary":160,"conditions":161,"keywords":202,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100565188","phase-2-agnostic-therapy-in-rare-solid-tumors-100565188","NCT06638931","Agnostic Therapy in Rare Solid Tumors","Phase II Basket Study to Evaluate the Tissue-agnostic Efficacy of Anti-Programmed Cell Death Protein 1 (Anti-PD1) Monoclonal Antibody in Patients With Advanced Rare Tumors","ANTARES","Inclusion Criteria\n\n1. Age 18 years or older.\n2. Patients with immunohistochemistry for PD-L1 with a combined positive score (CPS) of 10 or higher.\n3. Patients with progression or intolerance to already approved and accessible treatments for the specific neoplasm and population.\n4. Documented disease progression radiologically after the last routine treatment.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Measurable lesion per RECIST v1.1. Lesions previously treated with radiotherapy can only be used as target lesions if they are confirmed to be progressing by imaging before enrollment.\n7. Male participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. No fertile partner;\n   3. Has a fertile partner who agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n\n      and\n   4. Agrees to abstain from sperm donation throughout the study period and for at least 6 months after the last dose of Nivolumab.\n8. Female participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. Agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n9. Estimated life expectancy greater than 12 weeks, as determined by the investigator or delegated sub-investigator.\n10. Preserved organ functions defined by:\n\n    * Absolute neutrophil count ≥ 1,000;\n    * Hemoglobin ≥ 8.0 g\u002FdL (patients may receive transfusions to reach this level);\n    * Platelet count ≥ 100,000;\n    * Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), or ≤ 3.0 × ULN for patients with Gilbert's syndrome;\n    * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases);\n    * Creatinine clearance \\> 30 mL\u002Fmin (estimated by Cockcroft-Gault).\n11. Diagnosis of rare cancer (List I) confirmed by histopathological examination, with the possibility of including other types of rare tumors (incidence of less than 6 in every 100,000) after careful evaluation and approval by the study board.\n\n    * List I:\n\n      * Urachal adenocarcinoma\n      * Parathyroid carcinoma\n      * Nasopharyngeal epithelial tumors\n      * Fibrolamellar carcinoma of any primary site\n      * Angiosarcoma of any primary site\n      * Secretory breast carcinoma\n      * Anal cancer\n      * Metaplastic breast carcinoma\n      * Chromophobe renal carcinoma, Microphthalmia-associated Transcription Factor (MiT) family translocation renal carcinoma; renal carcinoma with Fumarate Hydratase (FH) or Succinate Dehydrogenase (SDH) deficiency\n      * Carcinosarcoma of any primary site\n      * Small intestine cancer\n      * Cholangiocarcinoma\n      * Sertoli-Leydig cell tumors\n      * Cervical cancer of non-epidermoid histology\n      * Tracheal epithelial tumors\n      * Non-cystadenoma salivary gland tumors\n      * Mesothelioma of any site\n      * Neuroblastoma\n      * Adrenal cancer\n      * Penile cancer\n      * Apocrine carcinoma\n      * Fibrosarcoma of any primary site\n      * Cancer of unknown primary site\n      * Hemangioblastoma of any primary site\n      * Thyroid cancer\n      * Hepatoblastoma\n      * Fallopian tube cancer\n      * Leiomyosarcoma of any primary site\n      * Vaginal cancer\n      * Neurofibrosarcoma of any primary site\n      * Gallbladder cancer\n      * Osteosarcoma of any primary site\n      * Bile duct cancer\n      * Clear cell endometrial carcinoma\n      * Yolk sac tumor of any primary site\n      * Non-epidermoid bladder cancer\n      * Vulvar cancer\n      * Kaposi's sarcoma\n      * Epithelial ovarian cancer\n      * Soft tissue sarcoma\n      * Urethral cancer\n      * Granulosa cell tumor of any primary site\n      * Cystadenoma carcinoma\n      * Primitive neuroectodermal tumor of any primary site\n      * Pure or mixed neuroendocrine tumors with neuroendocrine component\n      * Trophoblastic tumor\n\nExclusion Criteria\n\n1. Previous treatment lines with immunotherapy (immune checkpoint inhibitors).\n2. Pregnant or breastfeeding individuals.\n3. Limiting comorbidity, in the opinion of the investigator.\n4. Active infection.\n5. Major surgery within the last 4 weeks.\n6. Functional class II or greater heart failure.\n7. Myocardial infarction or stroke within the last 6 months.\n8. History of pulmonary fibrosis or pneumonitis.\n9. Autoimmune diseases, except for patients with vitiligo and\u002For controlled thyroid\u002Fhypothyroidism without the use of immunosuppressors.\n10. Second invasive primary tumor diagnosed in the last 3 years and\u002For with active disease, except for localized skin tumors (non-melanoma) that have been treated with curative intent.\n11. Patients with prolonged QT interval.\n12. Uncontrolled Central Nervous System (CNS) metastases. Patients who have previously received local treatment, such as radiotherapy, will be eligible if clinical and radiological stability is demonstrated in the 2 weeks prior to the start of treatment. Patients must not be using corticosteroids for managing CNS disease.\n13. Presence of meningeal carcinomatosis.\n14. Worsening renal and liver function in the 14 days prior to enrollment.\n15. History of solid organ transplantation with or without immunosuppression.\n16. Patients with untreated acquired immunodeficiency. Immunocompromised patients may be included as long as they do not have active opportunistic disease and\u002For active infection, after thorough clinical evaluation by the investigator or sub-investigator. HIV-positive patients must have documented undetectable viral load prior to inclusion.\n17. Chronic use of corticosteroids at doses greater than 10 mg\u002Fday of prednisone or equivalent. Patients with adrenal insufficiency of non-autoimmune etiology (e.g., previous bilateral adrenalectomy) may be included if they are clinically compensated with 10 mg\u002Fday of prednisone or equivalent or less.",{"count":158,"type":19},28,[23],"The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.\n\nThe study aims to treat rare malignancies with PD-L1 expression (CPS ≥ 10), regardless of the tumor's tissue type or location. Patients who have not responded to standard treatments will be included, and treatment will last for up to 12 months. The study will assess objective response, progression-free survival, and biomarkers such as PD-L1, ctDNA, and microvesicles, in a multicenter collaborative effort to provide innovative therapeutic options for this underrepresented population",[162,163,164,33,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201],"Urachal Cancer","Parathyroid Carcinoma","Fibrolamellar Carcinoma","Secretory Carcinoma of Breast","Anal Neoplasms","Metaplastic Breast Carcinoma","Translocation Renal Cell Carcinoma","Carcinosarcoma","Small Intestine Neoplasms","Cholangiocarcinoma","Sertoli-Leydig Cell Tumor","Adenoid Cystic Carcinoma","Mesothelioma","Neuroblastoma","Adrenal Gland Neoplasms","Penile Neoplasms","Apocrine Carcinoma","Fibrosarcoma","Cancer of Unknown Primary","Hemangioblastoma","Thyroid Neoplasms","Hepatoblastoma","Fallopian Tube Neoplasms","Leiomyosarcoma","Vaginal Neoplasms","Neurofibrosarcoma","Gallbladder Neoplasms","Osteosarcoma","Biliary Tract Neoplasms","Clear Cell Endometrial Cancer","Yolk Sac Tumor","Vulvar Neoplasms","Kaposi Sarcoma","Ovarian Epithelial Cancer","Soft Tissue Sarcoma","Urethral Neoplasms","Granulosa Cell Tumor","Primitive Neuroectodermal Tumor","Neuroendocrine Tumors","Trophoblastic Tumor",[203,163,204,164,33,205,206,167,207,169,208,171,209,210,211,212,174,175,213,214,178,179,180,181,215,183,216,185,217,187,218,189,219,191,192,220,221,194,195,196,222,198,173,199,200,201],"Urachal Adenocarcinoma","Nasopharyngeal Epithelial Tumors","Secretory Breast Carcinoma","Anal Cancer","Chromophobe Renal Carcinoma","Small Intestine Cancer","Sertoli-Leydig Cell Tumors","Non-Squamous Cervical Neoplasm","Tracheal Epithelial Tumors","Non-Adenoid Cystic Salivary Tumors","Adrenal Neoplasm","Penile Cancer","Thyroid Cancer","Fallopian Tube Cancer","Vaginal Cancer","Gallbladder Cancer","Biliary Tract Cancer","Non-Squamous Bladder Cancer","Vulvar Cancer","Urethral Cancer","2026-04-10",{"date":225,"type":93},"2026-04-15",{"date":227,"type":93},"2024-07-16",{"date":229,"type":19},"2028-05",{"name":231,"class":100},"Instituto do Cancer do Estado de São Paulo",8,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":242,"phases":4,"briefSummary":243,"conditions":244,"keywords":255,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":268},"100626230","precision-medicine-approaches-for-neoadjuvant-therapy-in-high-risk-sarcoma-patients-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":241,"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.",[245,246,247,248,249,250,251,252,253,27,254,33],"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","Retroperitoneal Sarcoma","Liposarcoma, Dedifferentiated","Leiomyosarcoma (LMS)",[256,257,258],"PANTHRS","PANTHRS-S","Sarcoma Accelerator","2026-02-18",{"date":261,"type":93},"2026-02-25",{"date":263,"type":93},"2021-11-19",{"date":265,"type":19},"2028-06-30",{"name":267,"class":100},"Royal Marsden NHS Foundation Trust",1,{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":15,"minAge":277,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":20,"phases":280,"briefSummary":282,"conditions":283,"keywords":288,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":315},"100366742","efficacy-and-safety-of-regorafenib-as-maintenance-therapy-after-first-line-treatment-in-patients-with-bone-sarcomas-100366742","NCT04055220","Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas","A Multicentre Exploratory Phase II Study Describing the Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas","REGOSTA","INCLUSION CRITERIA :\n\nI1. Age ≥ 12 years at the day of consenting to the study;\n\nI2. Patients must have histologically confirmed diagnosis of primary bone sarcoma including but not limited to: Osteosarcomas, Ewing sarcomas, Chondrosarcomas, Undifferentiated Pleomorphic Sarcomas (UPS), Leiomyosarcomas (LMS) and Angiosarcomas;\n\nI3. Prior treatment for localized or metastatic disease for bone sarcoma must have been completed, consisting of a standard multimodal treatment based on the histological subtype:\n\nFor OS, (excepted head and neck localisations), neoadjuvant and\u002For adjuvant chemotherapy should include methotrexate-based regimen for patients \\\u003C 18 years old; patients ≥ 18 years old may have received either methotrexate-based regimen or anthracycline and cisplatin-based regimen For head and neck OS, neoadjuvant and\u002For adjuvant chemotherapy should include adriamycin, cisplatin or ifosfamide-based regimen.\n\nFor non-OS, neoadjuvant and\u002For adjuvant chemotherapy should include adriamycin and\u002For cisplatin-based regimen.\n\nI4. Recovery to NCI-CTCAE v5 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug\u002Fprocedure related toxicity (except alopecia, anaemia, and hypothyroidism);\n\nI5. Interval between the last chemotherapy administration and the date of randomisation: at least 4 weeks but no longer than 2 months;\n\nI6. Confirmed complete remission or no evidence of disease (for metastatic disease);\n\nPatients with pulmonary micro nodules can be included provided they do not meet the following criteria:\n\n* At least one lung nodule of 10mm or more\n* And\u002For at least two nodules well limited between 6-9mm\n* And\u002For at least 5 nodules well limited of 5mm or less All the other situations will be considered as doubtful lesions except in case of metastatic disease confirmed during the lung surgery of the residual lung lesions after pre-operative chemotherapy. If no other metastatic localisation is detected at the initial staging, the patient will be considered as localised disease and eligible for randomisation.\n\nI7. Life expectancy of greater than 12 months;\n\nI8. Karnofsky Performance status ≥70 (patients younger than 18-year old) or ECOG performance status \\\u003C 2 (adult patients) ;\n\nI9. Patients must have adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:\n\n* Absolute neutrophil count ≥ 1.5 Giga\u002Fl\n* Platelets ≥ 100 Giga\u002Fl\n* Haemoglobin≥ 9 g\u002Fdl\n* Serum creatinine ≤ 1.5 x ULN\n* Glomerular filtration rate (GFR) ≥30 ml\u002Fmin\u002F1.73m2 according to the Modified Diet in Renal Disease (MDRD) abbreviated formula\n* AST and ALT ≤2.5 x ULN ( ≤5.0 × ULN for patients with liver involvement of their cancer)\n* Bilirubin ≤1.5 X ULN\n* Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in patient with liver involvement of their cancer). If Alkaline phosphatase \\> 2.5 ULN, hepatic isoenzymes 5-nucleotidase or GGT tests must be performed; hepatic isoenzymes 5-nucleotidase must be within the normal range and\u002For GGT \\\u003C 1.5 x ULN.\n* Lipase ≤1.5 x ULN\n* Spot urine must not show ≥ 1 \"+\"protein in urine or the patient will require a repeat urine analysis. If repeat urinalysis shows 1 \"+\" protein or more, a 24-hour urine collection will be required and must show total protein excretion \\\u003C1000 mg\u002F24 hours\n\nI10. INR\u002FPTT ≤1.5 x ULN; Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR\u002FPTT is stable based on a measurement that is pre-dose as defined by the local standard of care;\n\nI11. Women of childbearing potential and male patients must agree to use adequate contraception (Appendix 4) for the duration of treatment and for 7 months (210 days) in WOCBP or 4 months (120 days) in men sexually active with WOCBP after the last dose of regorafenib;\n\nI12. Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior randomization and\u002For urine pregnancy test within 48 hours before the first administration of the study treatment;\n\nI13. Patients, and their parents when applicable, must sign and date an informed consent document indicating that they have been informed of all the pertinent aspects of the trial prior to enrolment;\n\nI14. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures;\n\nI15. Patients covered by a medical insurance.\n\nI16. Body Surface Area (BSA) ≥ 1.30m² at the time of consenting to the study.\n\nNON-INCLUSION CRITERIA :\n\nE1. Prior treatment with any VEGFR inhibitor (thus, any prior exposure to sunitinib, sorafenib, pazopanib, bevacizumab, or other VEGFR inhibitor);\n\nE2. All soft tissue sarcomas (including but not limited to soft tissue osteosarcomas and Ewing soft tissue sarcomas) and chordomas;\n\nE3. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within 3 years prior to randomization;\n\nE4. Cardiovascular dysfunction:\n\n* Left ventricular ejection fraction (LVEF) \\\u003C 50%,\n* Congestive heart failure ≥ New York Heart Association (NYHA) class 2,\n* Myocardial infarction \\\u003C 6 months prior to first study drug administration,\n* Cardiac arrhythmias requiring therapy (beta blockers or digoxin are permitted),\n* Unstable (angina symptoms at rest) or new-onset angina within the last 3 months prior to first study drug administration;\n\nE5. Uncontrolled hypertension (systolic blood pressure \\> 150mmHg or diastolic pressure \\> 90 mmHg despite optimal treatment);\n\nE6. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the last 6 months before the first study drug administration;\n\nE7. Major surgical procedure, open biopsy or significant traumatic injury within 28 days before the first study drug administration;\n\nE8. Ongoing infection \\> Grade 2 according to NCI-CTCAE v5;\n\nE9. Known history of human immunodeficiency virus (HIV) infection;\n\nNota Bene: Subjects with diagnosed human immunodeficiency virus (HIV) are eligible to participate in the study if they meet the following criteria:\n\n1. No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months prior to enrolment;\n2. No history of AIDS-defining cancers (e.g. Kaposi's sarcoma, aggressive B-cell lymphoma and invasive cervical cancer);\n3. Subjects should be on established anti-retroviral therapy for at least 4 weeks and have an HIV viral load of \\\u003C 400 copies\u002FmL prior to enrolment;\n\nE10. Active hepatitis B or C or chronic hepatitis B or C requiring treatment with antiviral therapy; Nota Bene: Subjects with a history of hepatitis B or C who have normal alanine aminotransferase (ALT) and are hepatitis B surface antigen negative and\u002For have undetectable HCV RNA are eligible;\n\nE11. Dehydration according to NCI-CTC v5 Grade \\>1;\n\nE12. Difficulties to swallow oral medication and\u002For any mal-absorption condition and\u002For any Gastrointestinal (GI) disease that may significantly alter the absorption of regorafenib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection);\n\nE13. Patients with seizure disorder requiring medication;\n\nE14. Concurrent enrolment in another clinical trial in which investigational therapies are administered;\n\nE15. Known hypersensitivity to the active substance or to any of the excipients;\n\nE16. Pregnant women, women who are likely to become pregnant or are breast-feeding\n\nE17. Patients with 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 registration in the trial;\n\nE18. Patients with history of non-compliance to medical regimens or unwilling or unable to comply with the protocol;\n\nE19. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent;\n\nE20. Non-healing wound, non-healing ulcer, or non-healing bone fracture;\n\nE21. Patients with evidence or history of any bleeding diathesis, irrespective of severity;\n\nE22. Any haemorrhage or bleeding event ≥ CTCAE v5 Grade 3 within 4 weeks prior to the first study drug administration;\n\nE23. Clinically significant unrelated systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results;\n\nE24. Patients using prohibited concomitant and\u002For concurrent medications (see section \"Prohibited concomitant\u002Fconcurrent treatments);\n\nE25.Patients under tutorship or curatorship.","12 Years",{"count":279,"type":19},168,[281],"NA","Randomized, non-comparative, multicentre exploratory phase II study.\n\nTwo arms concerning patients with bone sarcoma after the first line therapy: in the first arm, patients will be treated with Regorafenib for a maximum of 12 months as maintenance therapy after first line therapy, whereas in the second arm, patients will be kept under surveillance (standard of care). Regardless of their study arm, all the patients will be followed up until end of the study.\n\nThe comparison between these two arms will allow to determine whether or not regorafenib is efficient for disease control, in terms of Relapse-Free Survival improvement.",[284,189,285,286,287,185,33],"Bone Sarcoma","Ewing Sarcoma","Chondrosarcoma","Undifferentiated Pleomorphic Sarcoma",[289,290,291,292,293,294,295,296,297,298,299,300,189,301,302,303,304,305],"Maintenance therapy","First line therapy","Regorafenib","Randomization","Double-blinded","Placebo controlled","Relapse-free survival","Time to treatment failure","Overall survival","Quality of life","Compliance","Bone sarcoma","Efficacy","Complete response","Tyrosine kinase inhibitor","Multi-target inhibitor","Safety","2026-02-13",{"date":308,"type":93},"2026-02-17",{"date":310,"type":93},"2020-03-03",{"date":312,"type":19},"2026-10-01",{"name":314,"class":100},"Centre Leon Berard",16,{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":20,"phases":325,"briefSummary":326,"conditions":327,"keywords":336,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":350},"100549895","phase-1-a-study-to-evaluate-safety-tolerability-and-preliminary-activity-of-agx101-in-participants-with-advanced-solid-tumors-100549895","NCT06440005","A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors","A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed unresectable, locally advanced, or metastatic solid tumors.\n* Refractory to or relapsed after all standard therapies known to provide proven clinical benefit, unless the patient is not a candidate for standard treatment, there is no standard treatment, or the patient refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit\n* Willing to authorize use of existing archival tissue, unless otherwise discussed with Sponsor\n* Time since the last dose of prior therapy to treat underlying malignancy (including other investigational therapy): Systemic cytotoxic chemotherapy: ≥ the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all, except 6 weeks for systemic nitrosourea or systemic mitomycin-C); Biologic therapy (eg, antibodies): ≥ 3 weeks; Small molecule therapies: ≥ 5 × half-life\n* Have an ECOG performance status of 0 to 1\n* Have adequate organ function\n* LVEF ≥ 50%, as determined on cardiac ECHO or cardiac multiple-gated acquisition (MUGA) scan\n* Highly effective contraception for both male and female patients throughout the study\n\nExclusion Criteria:\n\n* Colorectal cancer patients with an unresected primary colorectal tumor and non-small-cell lung cancer with predominant squamous histology (ie, squamous cell carcinoma of the lung) are excluded unless otherwise discussed and approved by Sponsor\n* Clinically unstable central nervous system (CNS) tumors or brain metastasis (stable and\u002For asymptomatic CNS metastases allowed)\n* Have not recovered to ≤ Grade 1 or baseline from all AEs due to previous therapies (patients with ≤ Grade 2 neuropathy, endocrine-related irAEs, or other AEs may be eligible after discussion with the Sponsor)\n* Has an active vasculitis that has required systemic treatment in the past 2 years prior to starting study treatment\n* Significant (ie, ≥ Grade 2) ocular disturbances\n* Variceal bleeding within 6 months prior to treatment, currently untreated or incompletely treated varices with bleeding, or who otherwise are at a high risk of bleeding\n* Any other concurrent antineoplastic treatment except for allowed local radiation of lesions for palliation (to be considered non-target lesions after treatment) and hormone ablation\n* Uncontrolled or life-threatening symptomatic concomitant disease, including known symptomatic HIV positive with an AIDS defining opportunistic infection within the last year, known symptomatic active hepatitis B or C, or known active tuberculosis\n* Has undergone a major surgery within 3 weeks prior to starting study treatment or has inadequate healing or recovery from complications of surgery prior to starting study treatment\n* Has received prior radiotherapy within 2 weeks prior to starting study treatment\n* Has or had a potentially life-threatening second malignancy requiring systemic treatment within the last 3 years, or which would impede evaluation of treatment response\n* Clinically significant cardiovascular disease\n* Patients on a potent CYP3A inhibitor or CPY3A inducer who cannot be changed to another medication\n* Has an active infection requiring concurrent systemic antibiotic therapy\n* A woman of child-bearing potential (WOCBP) who has a positive pregnancy test prior to treatment\n* Is breastfeeding or expecting to conceive or father children within the projected duration of the study",{"count":324,"type":19},80,[22],"AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population. AGX101will be administered intravenously.\n\nDosing of AGX101 will be repeated once every 3, 6 or 9 weeks. Participants may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug.",[129,328,329,330,117,331,332,333,334,33,335],"Advanced Cancer","Locally Advanced Carcinoma","Metastatic Solid Tumor","Prostate Cancer","Colorectal Cancer","Pancreatic Cancer","Liver Cancer","Solid Tumor",[337,338,339],"ADC","Antibody Drug Conjugate","AGX101","2026-02-08",{"date":342,"type":93},"2026-02-11",{"date":344,"type":93},"2024-07-22",{"date":346,"type":19},"2027-09-06",{"name":348,"class":349},"Angiex, Inc.","INDUSTRY",6,{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":20,"phases":362,"briefSummary":363,"conditions":364,"keywords":369,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":268},"100581413","phase-2-io-combined-with-ai-as-first-line-treatment-for-patients-with-soft-tissue-sarcomatais-100581413","NCT06849986","IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS)","Tislelizumab Combined With Liposomal Doxorubicin and Ifosfamide as First-line Treatment for Patients With Specified Subtypes of Unresectable or Metastatic Soft Tissue Sarcoma: a Multi-center, Single-arm, Prospective Phase II Clinical Trial","TAIS","Inclusion Criteria:\n\n* Age 18 to 75 years, regardless of gender;\n* Patients with histopathologically confirmed undifferentiated sarcoma (except small round cell undifferentiated sarcoma), synovial sarcoma, angiosarcoma, fibrosarcoma, smooth muscle sarcoma, liposarcoma (except well differentiated liposarcoma), pleomorphic rhabdomyosarcoma, malignant peripheral nerve sheath meningiomas, desmoplastic small round cell tumor, not other specified (NOS), SMARCA4-deficient sarcoma, malignant phyllodes tumor of the breast, intimal sarcoma.\n* Patients with locally advanced disease that is not amenable to surgery\u002Fradiation therapy or with recurrent\u002Fmetastatic disease;\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1;\n* Expected survival of more than 3 months;\n* Within 7 days prior to screening (including day 7), laboratory test data requirements: neutrophil count ≥1.5×10⁹\u002FL, platelet count ≥90×10⁹\u002FL, hemoglobin ≥90g\u002FL (no blood transfusion within 14 days), serum total bilirubin ≤1.5 times the upper limit of normal (ULN); ALT and AST ≤2.5× ULN (≤5× ULN for patients with liver metastases); serum creatinine ≤1.5× ULN or creatinine clearance rate ≥50ml\u002Fmin;\n* Presence of measurable lesions according to RECIST 1.1 criteria;\n* The subject (or their legal representative\u002Fguardian) must sign an informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures, and are willing to participate in this study.\n\nExclusion Criteria:\n\nAny of the following conditions will result in exclusion from the study:\n\n* Previous treatment for advanced soft tissue sarcoma, except for those who relapsed more than six months after adjuvant therapy with a cumulative dose of doxorubicin ≤300mg\u002Fm2;\n* Received any experimental or anti - tumor drugs within 4 weeks prior to enrollment;\n* Previously received any anti - PD - 1, anti - PD - L1, anti - PD - L2, anti - CD137, or anti - CTLA - 4 antibody treatment, or any other antibodies or drugs specifically targeting T - cell co - stimulation or checkpoint pathways;\n* History of other tumors within the past five years, except for cured cervical cancer or skin basal cell carcinoma; for patients with post - radiation sarcoma, another primary tumor must have no recurrence or metastasis;\n* Symptomatic brain or meningeal metastasis (unless the patient has been treated for more than 6 months, with negative imaging results within 4 weeks prior to enrollment, and stable tumor - related clinical symptoms at the time of enrollment);\n* Clinically significant active bleeding;\n* Pregnant or lactating women; women of childbearing potential who have not taken adequate contraceptive measures;\n* Alcohol abuse or drug addiction;\n* Patients with active autoimmune diseases or a history of such diseases that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or those at high risk (such as patients who have undergone organ transplantation and require immunosuppressive therapy). Autoimmune hypothyroidism requiring only hormone replacement therapy or skin diseases not requiring systemic treatment are excluded;\n* Patients who need to receive systemic corticosteroids (equivalent to \\>10mg prednisone\u002Fday) within 14 days prior to enrollment or during the study, or those who require other immunosuppressive drug treatment. The use of topical or inhaled corticosteroids, or short - term (≤7 days) use of corticosteroids for prevention or treatment of non - autoimmune, non - frequent allergic diseases is excluded;\n* Failure of important organs or other severe diseases, including interstitial pneumonia, clinically significant coronary artery disease, cardiovascular disease, or myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrollment;\n* History of human immunodeficiency virus infection, or other acquired or congenital immune deficiency diseases, or history of organ transplantation or stem cell transplantation;\n* Patients with active chronic hepatitis B or active hepatitis C. HBV carriers, those with stable hepatitis B after drug treatment (DNA titer ≤10\\^3 copies\u002Fml), and those with cured hepatitis C (HCV RNA negative) are eligible for enrollment;\n* Severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation, or other concomitant diseases that, in the opinion of the investigator, seriously endanger the safety of the patient or affect the patient's ability to complete the study.","75 Years",{"count":361,"type":19},45,[23],"This study will enroll patients with specific subtypes of unresectable or metastatic soft tissue sarcoma, and will combine tislelizumab with the standard chemotherapy of liposomal doxorubicin and ifosfamide to initially explore the efficacy and safety.",[365,33,179,185,366,367,368],"Soft Tissue Sarcomas","Pleomorphic Liposarcoma","Malignant Peripheral Nerve Sheath Tumor (MPNST)","Desmoplastic Small Round Cell Tumor",[370,371,372,373],"soft tissue sarcoma","tislelizumab","doxorubicin","ifosfamide","2026-01-07",{"date":376,"type":93},"2026-01-08",{"date":378,"type":93},"2025-02-25",{"date":380,"type":19},"2029-12-31",{"name":382,"class":100},"Fudan University",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":20,"phases":392,"briefSummary":393,"conditions":394,"keywords":410,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":101},"100505262","phase-1-a-study-of-mq710-with-and-without-pembrolizumab-in-people-with-solid-tumor-cancer-100505262","NCT05859074","A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer","A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors","Inclusion Criteria:\n\n* Age 18 or over\n* Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two lines of prior therapy in the advanced setting unless there are fewer than two FDA approved lines of therapy for the particular disease, or for which no standard treatment is available\n* At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of lesions, ≥0.5 cm for any single lesion and cumulative lesion dimensions. One lesion must meet criteria for RECIST measurable disease if in Part 2. Note: One lesion will be biopsied (if possible)\n* Mandatory initial screening biopsy\n\n  a. For patients undergoing surgical excision\u002Fresection: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to biopsy and surgical procedure iii. Patient able to undergo surgical procedure and appropriate anesthesia b. For patients not undergoing surgical excision\u002Fresection to obtain mandatory screening biopsy: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to initial tumor biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients with no curative treatment options available including surgery and\u002For definitive radiation or patients in which these modalities are associated with significant morbidity\n* Patients with advanced disease who have received and progressed on standard therapy or have disease for which there is no standard therapy or have contraindications to standard therapy\n\nPart 1a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. Any malignancy with superficial cutaneous or subcutaneous lesions or palpable lymph nodes may be eligible based on the discretion of the investigator.\n\n* Part 2a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. BCC will also be included, given that pembrolizumab has not been approved for this condition, although cemiplimab is approved.\n* Parts 1b and 2b: Patients must have cSCC, Merkel cell carcinoma, melanoma, or head and neck squamous cell carcinoma. These patients should be refractory to anti-PD-1 therapy, with the exception of patients with HNSCC with PD-L1 expression \\\u003C1.\n* Parts 1a, 2a and 2b: Patients with BRAF-mutated melanoma should have received BRAF-targeted therapy.\n* Predicted life expectancy of 3 months or more (in both Part 1 and Part 2)\n* Participant or their legally authorized representative (LAR able to provide written informed consent to participate\n* Ability to comply with study procedures in the Investigator's opinion\n* Adequate renal function as defined by Cr \\\u003C2 mg\u002FdL\n* Adequate hepatic function\n\n  1. Serum bilirubin ≤1.5 x ULN\n  2. AST and ALT ≤2.5 ULN (no liver mets)\n  3. AST and ALT ≤5.0 ULN (for patients with liver mets)\n* Adequate bone marrow and hematologic function\n\n  1. Coagulation function adequate (PT and aPTT within x1.5 ULN)\n  2. Platelets ≥ 75,000\u002Fmm\\^2\n  3. ANC ≥ 1000\u002FuL\n* Females of child-bearing potential must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days after the last dose of MQ710\n* Part 2 only: at least one measurable site of disease according to RECIST criteria\n* Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical\u002Fradiotherapy, targeted therapy, or major surgery (but not anti-PD1\u002F- L1 therapies) was discontinued for more than 4 weeks prior to enrollment\n* Patients who have failed prior anti-PD1\u002F-PDL1 may be included. Washout of anti-PD1\u002F-PDL1 at least 3 weeks prior to initiation of therapy in Part 1a and 2a. No washout period is required for Part 1b and 2b.\n\nExclusion Criteria:\n\n* Splenectomy\n* Active infections requiring antibiotics, physician monitoring or recurrent fevers (\\>38.0 ℃) associated with a clinical diagnosis of active infection\n* Acute or chronic active viral disease or positive test for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) with CD4 count \\\u003C100mg\u002Fm3, or received treatment with antivirals or nucleoside analogs such as those used in the treatment of hepatitis B (e.g. lamivudine, adefovir, tenofovir, telbivudine, entecavir), ribavirin, cidofovir, diaminopurine analogs, methyladenosine analogs, or interferon alpha within 4 weeks of initiation of study treatment .a. Patients with HIV are allowed on study if CD4 count is \\>100 cells\u002Fmm3.\n* Incomplete recovery from surgery, incomplete healing of an incision site\n* Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding\u002Fhaemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia\n* History of myocardial infarction, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classsification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia,or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment\n* Uncontrolled infection within 6 months prior to study entry.\n* History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment\n* Treatment with PD-1\u002Fprogrammed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 3 weeks before the first dose of study treatment\n* Prior chemotherapy, radiotherapy, biological cancer therapy (not including anti-PD1\u002F-L1 immunotherapies), targeted therapy, investigational drug, or major surgery 28 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment with the exception of grade 2 or better for alopecia and neuropathy.\n* Has known active CNS metastases and\u002For carcinomatous meningitis\n* Received live vaccine within 28 days prior to enrollment\n* Patient is pregnant or breast-feeding, or expecting to conceive or father children within the duration of the trial\n* Patients with tumor that directly contacts, encases or penetrates a major blood vessel, pericardium, gastrointestinal tract, or other hollow organs that may lead to perforation due to tumor necrosis\n* Patients at risk of airway compromise in the event of post-injection tumor swelling\u002Finflammation based on investigator judgement\n* History or evidence of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)\n* History of chronic liver disease or evidence of hepatic cirrhosis\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, active interstitial lung disease (ILD) requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% on room air\n* History of re-irradiation to a field which includes the carotid arteries\n* History of leukemia: ALL and CLL (patients with a history of aggressive lymphomas in remission or patients with a history of allogeneic stem cell transplants are eligible if no longer on immunosuppressive therapy and without evidence of GvHD)\n* Current use of steroids such as prednisone 10 mg\u002Fdaily or greater (or its equivalent) or immunosupressants within 2 weeks of initiation of study treatment\n* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results\n* Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent\n* Known allergy to MQ710 transgene products or formulation.\n* Patient requires anticoagulation therapy, such as warfarin.",{"count":391,"type":19},56,[22],"Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.",[395,396,397,398,399,400,401,402,403,194,404,405,406,33,407,328,408,409,335],"Cutaneous Squamous Cell Carcinoma","SCC - Squamous Cell Carcinoma","Basal Cell Carcinoma","BCC","BCC - Basal Cell Carcinoma","Melanoma","Merkel Cell Carcinoma","Sebaceous Carcinoma","Extramammary Paget Disease","Head and Neck Squamous Cell Carcinoma","HNSCC","Adnexal Carcinoma","Cutaneous Neoplasm","Metastatic Cancer","Refractory Cancer",[395,396,397,398,400,401,402,403,194,404,405,406,33,407,328,408,409,411,412,413,335],"MQ710","Memorial Sloan Kettering Cancer Center","22-278","2025-12-02",{"date":416,"type":93},"2025-12-03",{"date":418,"type":93},"2023-05-04",{"date":420,"type":19},"2028-05-04",{"name":412,"class":100},{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":242,"phases":4,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":443},"100544980","prospective-observational-study-of-localized-angiosarcoma-of-any-site-prostars-100544980","NCT06375941","Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars","ProStars","Inclusion Criteria:\n\n* pathological diagnosis of AS;\n* any site of origin;\n* any age;\n* primary, localized, resectable disease.\n\nExclusion Criteria: NA",{"count":430,"type":19},250,"This study will be a multi-institutional, prospective, observational study of patients with localized primary AS of any site within ISG and RTR centers. Patients will be treated according to clinical practice of the center and according to ISG clinical recommendations on localized AS.",[33],"2025-11-17",{"date":435,"type":93},"2025-11-20",{"date":437,"type":93},"2024-03-29",{"date":439,"type":19},"2034-04-01",{"name":441,"class":442},"Italian Sarcoma Group","NETWORK",19,{"id":445,"slug":446,"hasResults":11,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":451,"enrollmentInfo":452,"targetDuration":4,"studyType":20,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":268},"100537386","phase-2-masct-i-combined-with-doxorubicin-and-ifosfamide-for-first-line-treatment-of-advanced-soft-tissue-sarcoma-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":453,"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.",[185,27,457,33,287,458,459,179,460,461,368],"Synovial Sarcoma","Epithelioid Sarcoma","Malignant Peripheral Nerve Sheath Tumors","Pleomorphic Rhabdomyosarcoma","Endometrial Stromal Sarcoma","2025-07-20",{"date":464,"type":93},"2025-07-24",{"date":466,"type":93},"2024-02-21",{"date":468,"type":19},"2027-02",{"name":470,"class":349},"HRYZ Biotech Co.",{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":15,"minAge":478,"maxAge":479,"enrollmentInfo":480,"targetDuration":4,"studyType":20,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":498,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":4},"100556576","evaluation-of-chest-ct-versus-chest-x-ray-for-lung-surveillance-after-curative-intent-resection-of-high-risk-truncal-extremity-soft-tissue-sarcoma-100556576","NCT06526897","Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","A Phase III Randomized Controlled Trial of Chest CT vs Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Patient must be ≥ 1 and ≤ 85 years old on the day of randomization\n* Patient must have and undergone curative-intent (R0 or R1) resection of an American Joint Committee on Cancer (AJCC) 8th edition stage III truncal or extremity soft tissue sarcoma\n* Patient must have a high-risk (grade 2 or 3) soft tissue carcinoma according to the French Federation of Cancer Centers Sarcoma Group (FNCLCC)\n\n  * Patients with the following histiotypes are eligible: dedifferentiated liposarcoma, pleomorphic liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, myxofibrosarcoma, fibrosarcomatous dermatofibrosarcoma protuberant variant, spindle cell sarcomas, pleomorphic sarcoma, fibrosarcoma,extra-skeletal myxoid chrondrosarcoma, extraskeletal Ewing and Ewing-like sarcoma, sarcoma not otherwise specified (NOS), or other grade 2 or grade 3 sarcomas not further classified\n  * Patients with a high-risk histiotype that is typically not graded, including adult pleomorphic rhabdomyosarcoma, synovial sarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma, epithelioid sarcoma, or clear cell sarcoma are eligible\n* Patient must have a tumor size ≥ 5 cm\n* Patient must have had a R0 or R1 oncologic resection on final pathologic report\n* Patient must have a baseline chest CT obtained within 30 days prior to randomization that is negative or detecting only non-suspicious nodules ≤ 4 mm\n* Patients receiving preoperative or post-operative chemotherapy and\u002For radiotherapy for the primary tumor are eligible. However, all chemotherapy and\u002For radiotherapy must be completed prior to randomization\n* Patient must not be pregnant due to the potential harmful risks associated with CXR and CT imaging to the unborn fetus\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not have a chest wall\u002Fupper truncal primary tumor requiring locoregional surveillance with CT or magnetic resonance imaging (MRI)\n* Patient must not have retroperitoneal, mesenteric\u002Fabdominal sarcoma\n* Patient must not have a primary bone sarcoma (including osteosarcomas, Ewings sarcoma, or chondrosarcomas), desmoid tumor, gastrointestinal stromal tumor (GIST), Kaposi sarcoma, pediatric rhabdomyosarcoma, nor uterine sarcoma\n* Patient must not have had a palliative or R2 resection\n* Patient must not require routine cross-sectional imaging of the chest\u002Flungs with CT\u002FMRI\u002Fpositron emission tomography (PET)\n* Patient must not have participation in another clinical trial that is incompatible with this study surveillance schema and follow-up regimen\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Pediatric patients (\\\u003C 18 years of age) and patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible. Child assent must be obtained as appropriate in accordance with institutional guidelines\n* Patient must be English speaking to be eligible for the quality of life (QOL) component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms","1 Year","85 Years",{"count":481,"type":19},1582,[281],"This phase III trial compares chest computed tomography (CT) to chest x-ray (CXR) for lung surveillance after curative-intent resection of high-risk truncal-extremity soft tissue sarcoma. Currently, complete oncologic resection (with or without radiation therapy) is the standard of care for most high-risk soft tissue sarcoma that has not spread to other parts of the body (localized). However, despite curative-intent resection, 20-40% of patients will develop cancer that has spread from where it first started (primary site) to other places in the body (distant metastases), with the lungs being the most common site. Thus, lung surveillance is important for detection of lung metastases in order to facilitate timely treatment. Although there is general agreement about the usefulness of postoperative surveillance, consensus is lacking regarding the optimal modality for lung surveillance after curative-intent resection for high-risk soft tissue sarcoma. Current National Comprehensive Cancer Network guidelines recommend chest imaging with CT or CXR every 3-6 months for 2-3 years, then every 6 months for the next two years, and then annually after that for high-risk tumors. Data from across the United States and internationally indicate that there is considerable variation in clinical practice with regards to the use of CXR versus CT chest for lung surveillance. The information gained from this trial may allow researchers to determine the effectiveness of varying imaging modalities needed for optimal surveillance for patients with extremity or truncal soft tissue sarcoma.",[485,486,487,488,33,489,490,491,492,179,493,185,494,32,366,495,245,196,250,496,497,457,287],"Adult Pleomorphic Rhabdomyosarcoma","AJCC Grade 2 Sarcoma","AJCC Grade 3 Sarcoma","Alveolar Soft Part Sarcoma","Clear Cell Sarcoma of Soft Tissue","Dedifferentiated Liposarcoma","Extraskeletal Ewing Sarcoma","Extraskeletal Myxoid Chondrosarcoma","Fibrosarcomatous Dermatofibrosarcoma Protuberans","Malignant Peripheral Nerve Sheath Tumor","Round Cell Sarcoma With EWSR1-non-ETS Fusion","Spindle Cell Sarcoma","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","NOT_YET_RECRUITING","2024-07-24",{"date":501,"type":93},"2024-07-30",{"date":503,"type":19},"2025-01-28",{"date":505,"type":19},"2032-11-01",{"name":507,"class":442},"ECOG-ACRIN Cancer Research Group",{"id":509,"slug":510,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":20,"phases":517,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":533},"100513153","phase-2-propranolol-and-pembrolizumab-in-advanced-soft-tissue-sarcoma-patients-100513153","NCT05961761","Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients","An Open Label Phase 2 Study on Propranolol and Pembrolizumab in Advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma - a Scandinavian Sarcoma Group Collaboration","PROPANE","Inclusion Criteria:\n\n* Subjects must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care\n* Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study\n* Histologically confirmed diagnosis of unresectable locally advanced or metastatic Angiosarcoma or Undifferentiated Pleomorphic Sarcoma, who has progressed\u002Ffailed to provide clinical benefit on first line standard chemotherapy.\n* Age ≥18 years\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of ≤2 at the time of enrollment.\n* Evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n* Available material from archived formalin-fixed paraffin-embedded tumor tissue obtained within 3 months of study enrollment for biomarker related studies. If not sufficient or available, a newly obtained core or excisional biopsy of a tumor lesion may be performed.\n* Patients must have normal organ and marrow function as defined below:\n* Absolute neutrophil count (ANC) ≥ 1 x 10⁹\u002FL\n* Platelet count ≥ 75 x 10⁹\u002FL\n* Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin ≤ 50 mmol\u002FL)\n* Aspartate transaminase (AST)\u002FAlanine transaminase (ALT) ≤ 5 x ULN\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin (using the Cockcroft-Gault formula)\n* Women of childbearing potential (WOCBP): Agreement to use contraceptive methods with a failure rate of \\\u003C 1 % per year during the treatment period and for at least 120 days after the treatment. Safe contraceptive methods for women are birth control pills, intrauterine device, contraceptive injection, contraceptive implant,contraceptive patch or contraceptive vaginal ring.\n* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year during the treatment period and for at least 120 days after the treatment.\n* Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception\n\nExclusion Criteria:\n\n* Have an anticipated life expectancy of \\\u003C3 months.\n* Moderate to severe degree of bronchial asthma or chronic obstructive pulmonary disease.\n* Acute or non-stable congestive heart failure\n* Any other condition listed as contraindication for treatment with propranolol according to SPC\n* Have received any previous systemic therapy targeting the PD-1\u002FPDL-1 signaling pathway or other immune checkpoint inhibitors.\n* Have received propranolol within 4 weeks prior to treatment.\n* Prior to study day one received radiation therapy, chemotherapy or targeted small molecule therapy within 2 weeks and\u002For monoclonal antibody treatment within 4 weeks.\n* Not recovered from the effects of previously administered agents\n* Clinically active or unstable CNS metastases as assessed by the treating physician\n* Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results\n* Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism Inclusion criteria\n* Subjects must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care\n* Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study\n* Histologically confirmed diagnosis of unresectable locally advanced or metastatic Angiosarcoma or Undifferentiated Pleomorphic Sarcoma, who has progressed\u002Ffailed to provide clinical benefit on first line standard chemotherapy.\n* Age ≥18 years\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of ≤2 at the time of enrollment.\n* Evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n* Available material from archived formalin-fixed paraffin-embedded tumor tissue obtained within 3 months of study enrollment for biomarker related studies. If not sufficient or available, a newly obtained core or excisional biopsy of a tumor lesion may be performed.\n* Patients must have normal organ and marrow function as defined below:\n* Absolute neutrophil count (ANC) ≥ 1 x 10⁹\u002FL\n* Platelet count ≥ 75 x 10⁹\u002FL\n* Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin ≤ 50 mmol\u002FL)\n* Aspartate transaminase (AST)\u002FAlanine transaminase (ALT) ≤ 5 x ULN\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin (using the Cockcroft-Gault formula)\n* Women of childbearing potential (WOCBP): Agreement to use contraceptive methods with a failure rate of \\\u003C 1 % per year during the treatment period and for at least 120 days after the treatment. Safe contraceptive methods for women are birth control pills, intrauterine device, contraceptive injection, contraceptive implant,contraceptive patch or contraceptive vaginal ring.\n* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year during the treatment period and for at least 120 days after the treatment.\n* Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception\n\nExclusion criteria\n\n* Have an anticipated life expectancy of \\\u003C3 months.\n* Moderate to severe degree of bronchial asthma or chronic obstructive pulmonary disease.\n* Acute or non-stable congestive heart failure\n* Any other condition listed as contraindication for treatment with propranolol according to SPC\n* Have received any previous systemic therapy targeting the PD-1\u002FPDL-1 signaling pathway or other immune checkpoint inhibitors.\n* Have received propranolol within 4 weeks prior to treatment.\n* Prior to study day one received radiation therapy, chemotherapy or targeted small molecule therapy within 2 weeks and\u002For monoclonal antibody treatment within 4 weeks.\n* Not recovered from the effects of previously administered agents\n* Clinically active or unstable CNS metastases as assessed by the treating physician\n* Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results\n* Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* Participants with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\n* Allergies and Adverse Drug Reaction\n* History of allergy to study drug components\n* History of severe hypersensitivity reaction to any monoclonal antibody\n* WOCBP who are pregnant or breastfeeding",{"count":324,"type":19},[23],"The goal of this phase 2 clinical trial is to test efficacy and tolerability of combining propranolol and pembrolizumab in patients with advanced angiosarcoma or undifferentiated pleomorphic sarcoma. The main questions aims to answer:\n\n* Primary: determine the progression-free survival rate (PFSR) at 3 months\n\nSecondary: determine the objective response rate (ORR), duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS). Ensure the safety and tolerability, Determine Quality of Life (QoL)\n\n• Exploratory: Characterize the TME\n\nParticipants will be asked to ensure\n\n* Baseline biopsy and further optional biopsies\n* Treatment propranolol 40 mg BID and pembrolizumab 2 mg\u002Fkg Q3 weeks\n* Evaluation, blood counts, QoL and blood samples for biomarkers according to schedule",[249,33,287],[138,521,522,523,245],"Propranolol","Pembrolizumab","PD-1 inhibitor","2023-07-23",{"date":526,"type":93},"2023-07-27",{"date":528,"type":93},"2021-08-17",{"date":530,"type":19},"2028-12",{"name":532,"class":100},"Niels Junker",4]