[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"soft-tissue-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:soft-tissue-sarcoma":34},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,75,0,25,[9,63,86,114,137,161,197,220,239,251,281,310,340,359,388,412,435,459,478,498,522,544,572,648,678],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":37,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100053405","phase-1-atezolizumab-plus-tivozanib-in-immunologically-cold-tumor-types-100053405",false,"NCT05000294","Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types","Inclusion Criteria:\n\n* Subjects must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has refused or for whom there are no standard therapies that impart significant clinical benefit in the opinion of the treating investigator.\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1 for phase 1B. An ECOG Performance Status less than or equal to 2 for phase 2.\n* Subjects must not have more than one malignancy at the time of enrollment\n* Adult subjects ≥ eighteen years of age\n* A clinical diagnosis consistent with stage IV \"immunogenically cold\" or otherwise incurable cancer of one of the following histologies: i) bile duct or gallbladder cancer ii) Metastatic breast cancer, HR-negative HER2-positive, who have received at least 3 lines of therapy for disease progression that includes: trastuzumab, pertuzumab\u002Ftrastuzumab, and ado-trastuzumab emtansine iii) neuroendocrine cancer with the following pathological characteristics: grade 2 or 3; well- or moderately- differentiated (Grades 1, 4, and poorly differentiated neuroendocrine pathologies are not eligible) iv) FIGO stage IV or metastatic (using 2021 FIGO classification) high grade serious or high grade endometrioid (based on local histopathological findings) ovarian cancer, primary peritoneal cancer and \u002F or fallopian-tube cancer that is platinum resistant, with no acceptable standard of care v) pancreatic adenocarcinoma vi) soft tissue sarcoma vii) prostate cancer subjects who are castrate-resistant (testosterone ≤ 50 ng\u002FdL) and have progressed on, declined, or are intolerant to other standard of care therapies. Subjects with prostate cancer must have failed at least one line of treatment with an androgen inhibitor (AI) (i.e. enzalutamide, abiraterone, etc.) or cytotoxic chemotherapy in the advanced or metastatic setting viii) vulvar cancer\n* Adequate hematologic and end-organ function\n* Subjects receiving therapeutic anticoagulation must be on a stable anticoagulant regimen for ≥ 2 weeks at start of protocol treatment\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative HIV test at screening with the following exceptions: subjects with a positive HIV test at screening are eligible only if they meet the following three conditions: 1) Are stable on anti-retroviral therapy 2) Have a CD4 count ≥ 200\u002FuL AND 3) Have an undetectable viral load.\n* Women of childbearing potential (WOCBP) must be using an adequate method of contraception (with a failure rate of \\\u003C1% per year) to avoid pregnancy throughout the study and for at least 160 days after the last dose of either study drug to minimize the risk of pregnancy.\n* Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving children for 160 days following the last dose of study drug.\n* Measurable disease by RECIST criteria\n* A life expectancy of ≥ 12 weeks\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Must have formalin-fixed paraffin embedded (FFPE) tissue or 12 unstained slides available for research purposes. Tissue must have been obtained within the last 3 years.\n* If a new biopsy is needed for diagnostic reasons, the biopsy must be performed from a tumor site that is not the only site of measurable disease\n* Subject must be able to swallow capsules\n\nExclusion Criteria:\n\n* Subjects with known MSI-H or dMMR tumor status\n* Subjects with severe uncontrolled hypertension as defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg\n* Subjects who have had prior treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 160 days after the last dose of study drug\n* Females who are pregnant or breastfeeding\n* History of leptomeningeal disease\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently, except in the case of ovarian cancer with ascites, which may require more frequent drainage). Subjects with indwelling catheters are allowed.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  1. subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n     * Rash must cover \\\u003C10% of body surface area\n     * Disease is well controlled at baseline and requires only lowpotency topical corticosteroids\n     * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* History of malignancy other than the malignancies listed in the inclusion criteria of enrollment within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n* Severe infection within 4 weeks prior to initiation of study treatment including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Note: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Current treatment with anti-viral therapy for hepatitis B virus (HBV)\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  1. Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  2. Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment, during treatment with atezolizumab, and for 160 days after the last dose of atezolizumab. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Subjects may receive non-live COVID-19 vaccine.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects with Tumor Mutation Burden (TMB) ≥10\n* Treatment with any cancer directed therapy (i.e. chemotherapy, radiation therapy, Y90, microwave ablation, immunotherapy, etc.) within 28 days of study start\n* Subjects with treated brain metastases that have remained stable for at least 90 days without steroids are allowed. Subjects with signs of symptoms or history of brain metastasis must have a CT or MRI of the brain within 30 days prior to the start of protocol therapy.\n* Subjects with autoimmune diseases requiring current treatment and subjects with history of severe autoimmune diseases, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency who are stable on therapy are allowed.\n* Inability to discontinue use of medications contraindicated by the study treatment\n* Proteinuria \\> 2.5 g\u002F24 hours or 3+ with urine dipstick\n* QTc interval \\> 470 at screening or known cardiovascular disease defined as (a) a clinically significant abnormal ECG at screening, or (b) myocardial infarction within 12 weeks prior to start of protocol therapy","ALL","18 Years","99 Years",{"count":20,"type":21},29,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies.\n\nDespite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically \"cold\" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer.\n\nVascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer.\n\nThrough the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.",[28,29,30,31,32,33,34,35,36],"Bile Duct Cancer","Gall Bladder Cancer","Breast Cancer","Neuroendocrine Tumors","Ovarian Cancer","Pancreatic Adenocarcinoma","Soft Tissue Sarcoma","Vulvar Cancer","Prostate Cancer",[38,39,40,41,42,43,44,45,46,47,48,49],"immunologically cold tumors","breast cancer","bile duct cancer","gallbladder cancer","neuroendocrine cancer","ovarian cancer","pancreatic adenocarcinoma","soft tissue sarcoma","prostate cancer","vulvar cancer","TKI","checkpoint inhibitor","RECRUITING","2026-07-10",{"date":53,"type":54},"2026-07-13","ACTUAL",{"date":56,"type":54},"2021-12-07",{"date":58,"type":21},"2027-06",{"name":60,"class":61},"University of Florida","OTHER",1,{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":62},"100054048","phase-1-novel-rna-lipid-particle-rna-lp-vaccine-for-anti-pd-1-antibody-therapy-sensitization-100054048","NCT05264974","Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization","Inclusion Criteria:\n\n* Adults ≥ 18 years old\n* ECOG performance ≤ 2\n* Lab values within the specified ranges:\n\n  * Hemoglobin ≥ 8G\u002FDL\n  * Platelets ≥ 100 thou\u002Fcumm\n  * Absolute Neutrophil Count (ANC) ≥ 1000 thou\u002Fcumm\n  * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  * AST and ALT ≤ 2.5 x ULN; If confirmed liver metastases: AST and ALT ≤ 5 x ULN\n  * Creatinine clearance (CrCl) ≥ 15 ml\u002Fmin (based on modified Cockcroft and Gault formula)\n* Must have measurable disease that is amenable to surgical sampling for RNA extraction, amplification, and loading of lipid particles\n* Subjects must not have more than one active malignancy at the time of enrollment (subjects 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 \\[as determined by the treating physician and approved by the PI\\] may be included)\n* Written informed consent obtained from the subject.\n* Participants of childbearing potential must have a negative serum pregnancy test at screening\n* Participants of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least four months after the last dose of study treatment to minimize the risk of pregnancy. Prior to study enrollment, participants of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.\n* Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for four months following the last dose of study treatment and must agree to not donate sperm during the study treatment period or for four months following the last dose of study treatment.\n\nAdditional eligibility criteria for subjects with melanoma:\n\n* Patients with stage II, stage III, or resected stage IV melanoma who received anti-PD-1-based therapy in the adjuvant or neoadjuvant setting (either monotherapy or combination therapy) and experienced progressive disease (PD) per RECIST 1.1 during treatment or within 6 months of completing the planned course of therapy. This includes patients who:\n\n  * Were planned to receive approximately 1 year of anti-PD-1-based therapy in the adjuvant setting but discontinued early due to toxicity and relapsed within 6 months of discontinuation;\n  * Received neoadjuvant anti-PD-1-based therapy (with or without subsequent surgery), including patients planned to complete approximately 1 year of total perioperative anti-PD-1-based therapy (neoadjuvant ± adjuvant), and experienced PD during therapy or within 6 months of completion or discontinuation;\n  * Received short-course neoadjuvant anti-PD-1-based therapy (including combination regimens), underwent surgery, were subsequently managed with surveillance (including those achieving pathologic complete response), and experienced relapse within 6 months of completion of neoadjuvant therapy.\n* Patients with unresectable or widespread metastatic (stage IV) melanoma who experienced PD per treating physician while receiving anti-PD-1-based therapy (either monotherapy or combination therapy) in any line of treatment.\n* Patients with unresectable or widespread metastatic (stage IV) melanoma who:\n\n  * Completed a planned course of anti-PD-1-based therapy (monotherapy or combination), including planned treatment durations of approximately 1 year or 2 years, and experienced PD within 6 months of completion; or\n  * Were planned to receive anti-PD-1-based therapy (for either 1 year or 2 years) but discontinued early due to toxicity and experienced PD within 6 months of discontinuation.\n* Both cutaneous and non-cutaneous melanoma subtypes (including uveal, mucosal, and acral lentiginous) are eligible.\n* Patients must:\n\n  * Have no contraindication to continued immune checkpoint therapy;\n  * Not have rapidly progressive disease requiring urgent alternative therapy; and\n  * Have no other viable approved salvage treatment options available, or decline currently approved salvage therapies.\n\nAdditional eligibility criteria for subjects with soft tissue sarcoma:\n\n* Evidence of spindle cell, pleomorphic, round cell, or epithelioid morphology on pathology suggestive of sarcoma as determined by a sarcoma pathologist\n* Evidence of progression or resistance to therapy as defined by the treating physician.\n* Must have measurable disease per RECIST 1.1\n* Original tumor site from soft tissue location i.e. lipomatous tissue, musculature, skin\n* Evidence of unresectable stage II disease; stage III or stage IV disease\n* Subjects with prior exposure to an immune checkpoint inhibitor (ICI) are eligible for enrollment; however, prior ICI therapy is not required unless receipt of an ICI constitutes part of the FDA-approved standard of care for their disease.\n\nExclusion Criteria:\n\n* Subjects that have an active second malignancy, however, previously treated early stage malignancies with no evidence of disease recurrence after 3 years of follow-up will be allowed\n* Subjects with a history of immune-mediated treatment-related adverse reactions leading to discontinuation of prior aPD1 therapy or severe hypersensitivity reaction to any monoclonal antibody or any other baseline risk in the opinion of the investigator that precludes continued use of aPD1 therapy\n* Patients with known active and symptomatic brain metastases or leptomeningeal metastases at time of inclusion. Patients with isolated brain lesions that have been treated with stereotactic radiosurgery or surgical resection as part of oligometastatic initial management prior to start of immunotherapy may be eligible as long as they have no new disease and are asymptomatic at time of inclusion.\n* If patients develop new brain metastases during the time between tumor sampling and vaccine generation and administration, patients may remain on study as long as they can receive definitive stereotactic radiosurgery or surgery to brain metastases and be able to resume systemic therapy within 6 weeks of discovery of new brain metastases.\n* Subjects who received an investigational drug in another clinical trial must wait 28 days or at least 5 half-lives of the study drug, whichever is shorter, prior to enrollment in this study\n* Patients must not have required systemic corticosteroids (anything greater than 10mg of prednisone of equivalent, daily) or other immunosuppressive medications within 14 days of the start of trial treatment.\n* Subjects with known active infection or immunosuppressive disease within seven days prior to tissue collection for vaccine creation or within seven days prior to vaccine administration (subjects on prophylactic agents are acceptable)\n* Subjects with any known life-threatening illness, medical condition, or organ system dysfunction (aside from their cancer), which in the investigator's opinion, could compromise subject safety\n* Subjects with known active hepatitis B virus or untreated hepatitis C virus, and, patients with previous history of hepatitis C who completed treatment for HCV are not excluded as long as they have no detectable viral load.\n* Subjects with known human immunodeficiency virus with CD4+T cells ≤ 350 cells\u002Ful, a positive viral load as determined by institutional standard testing, or a known history of AIDS defining opportunistic infection within the last 12 months per subject medical records.\n* Known clinically relevant active autoimmune disease that would pose significant risk to the patient's life should a flare ensue. Patients with chronic autoimmune rheumatologic endocrine, or psoriatic skin diseases may still be eligible pending they are not receiving systemic immunosuppression at the time of treatment as previously described and that patients are aware of the increased risk of flare provocation with treatment.\n* Symptomatic congestive heart failure (NYHA Class 3 or 4)\n* Subjects with unstable angina pectoris\n* Known unstable cardiac arrythmias, abnormalities or transmural myocardial infarction within the last 6 months of treatment\n* Subjects who are post-splenectomy, otherwise asplenic, or have moderate to severe splenomegaly (defined as a spleen larger than 13 cm in cranial-caudal height or longest diameter)\n* Personal history of anaphylactic reaction to previous vaccination\n* Known hypersensitivity to the active substance or to any of the excipients\n* Participants of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 months after the last dose of study treatment\n* Participants who are confirmed to be pregnant or breastfeeding\n* Known history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID vaccine are allowed.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects with sarcoma originating from bone or cartilage\n* Sarcomatous malignancies lacking metastatic potential i.e. well-differentiated liposarcoma, dermatofibrosarcoma protuberans, desmoid fibromatosis, etc.",{"count":70,"type":21},18,[24],"The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of completion of adjuvant treatment, or unresectable stage II soft tissue sarcoma or stage III-IV soft tissue sarcoma.",[74,34],"Melanoma",[76,77,78,79,45],"melanoma","immunotherapy","vaccines","RNA-NP",{"date":53,"type":54},{"date":82,"type":54},"2026-03-17",{"date":84,"type":21},"2026-12",{"name":60,"class":61},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":62},"100632525","integration-of-adaptive-proton-therapy-in-pediatric-solid-tumors-and-hodgkins-lymphoma-100632525","NCT07514819","Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Participants diagnosed with solid tumors, including Rhabdomyosarcoma, Osteosarcoma, Ewing sarcoma, other sarcomas and carcinomas or also Hodgkin's lymphoma.\n* Participants who receive proton radiation therapy at St. Jude Children's Research Hospital.\n* Research participant or legal guardian\u002Frepresentative gives written informed consent.\n\nExclusion Criteria:\n\n* Participants who are not diagnosed with solid tumors or Hodgkin's lymphoma.\n* Participants who are diagnosed with Wilm's tumor or neuroblastoma\n* Participants who do not undergo proton therapy.\n* Participants who are prescribed equal or less than 5 fractions of proton therapy.\n* Participants with severe comorbid conditions that may impact imaging feasibility.\n* Inability to obtain written consent from research participant or legal guardian\u002Frepresentative.\n* Females of child-bearing potential cannot be pregnant or breast-feeding. Female participants \\>10 years of age or post-menarchal must have a negative serum or urine pregnancy test\n\nAll participants receiving proton therapy at St. Jude Children's Research Hospital will be screened for participation on this research protocol based on the Inclusion Criteria and the Exclusion Criteria. Qualified candidates will be selected during the consultation.",{"count":93,"type":21},100,[95],"NA","Pediatric patients receiving proton therapy for solid tumors or Hodgkin's lymphoma may experience anatomical changes during treatment that can affect proton therapy accuracy. This prospective single-arm study uses regular low-dose imaging to monitor these changes and adjust treatment plans as needed. Participants will receive weekly or every-other-week CT scans, with MRI when appropriate, to assess whether the original plan remains accurate. Treatment plans will be updated if tumor coverage decreases by more than 5% or if radiation dose to normal tissues increases by more than 10%; otherwise, the original plan will continue. The study aims to determine how often plan adjustments are needed and to identify which disease sites are most likely to experience significant anatomical changes during treatment.\n\nPrimary Objective:\n\n* Define the frequency of replanning necessary to ensure tumor coverage never falls below 95% (or 5% drop) of the prescribed daily dose in participants with intact (gross) tumors to keep the tumor control optimal throughout the multi-week treatment regimen.\n* Define the frequency of replanning necessary to ensure organs-at-risk (critical organs) do not deviate by more than 10% of the initially approved dose constraints to keep the normal tissue complication minimal throughout the multi-week treatment regimen.\n\nSecondary Objectives\n\n* Establish a cone beam CT (CBCT)-based framework for quantifying body surface changes throughout the treatment course. This goal will be achieved by developing a novel algorithm that detects and tracks external anatomical variations longitudinally, without requiring CBCT image enhancement, enabling precise assessment of daily participant setup consistency and anatomical stability.\n* Overcome daily CBCT quality limitations by generating synthetic CT images that accurately represent daily anatomy and support proton dose recalculation or verification planning. This goal will be achieved by developing a hybrid pipeline that integrates deep learning models with the deformable image registration algorithm, trained and validated on disease site-specific data. This will enable precise dose mapping and tissue density estimation, directly supporting adaptive planning decisions without the need of diagnostic- quality CT images.",[98,99,100,101,102,103,34],"Pediatric Solid Tumors","Rhabdomyosarcoma","Ewing Sarcoma","Osteosarcoma","Hodgkin Lymphoma","Bone Tumor","NOT_YET_RECRUITING","2026-06-30",{"date":107,"type":54},"2026-07-02",{"date":109,"type":21},"2026-08",{"date":111,"type":21},"2031-08",{"name":113,"class":61},"St. Jude Children's Research Hospital",{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":62},"100348562","circulating-tumor-dna-in-soft-tissue-sarcoma-100348562","NCT03818412","Circulating Tumor DNA in Soft Tissue Sarcoma","Circulating Tumor DNA Detection in Soft Tissue Sarcoma (DNA-TSAR)","Inclusion Criteria:\n\n* Patients must have histologically confirmed high-risk extremity or retroperitoneal liposarcoma, leiomyosarcoma and undifferentiated pleomorphic sarcoma.\n* Patients must have archival tissue from the diagnostic biopsy available.\n* Deemed appropriate for preoperative or postoperative radiotherapy and curative surgery following patient assessment by radiation oncologist and surgical oncologist.\n* Age 18 years or older.\n* Eastern Cooperative Group (ECOG) performance status ≤ 2\n* Ability to understand and willing to sign a written informed consent document and comply with study requirements.\n\nExclusion Criteria:\n\n* Patients with benign histology\n* Patients with prior malignancy within previous 5 years or concurrent malignancy other than adequately treated basal cell carcinoma of skin or carcinoma in-situ of cervix.\n* Patients with planned neo-adjuvant chemotherapy.\n* Patients with regional nodal disease or unequivocal metastases\n* Uncontrolled inter-current 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.",{"count":122,"type":21},40,[95],"This research study will collect blood and tumor tissue samples from patients with soft tissue sarcoma to look at circulating tumor deoxyribonucleic acid (DNA). When tumor cells are damaged or die, DNA from the tumor cells are released into the blood stream as the cells break down. This is called circulating tumor DNA. Circulating tumor DNA is an important biomarker that may be used in cancer detection, prediction of treatment response, and disease monitoring.",[34],[127],"Circulating tumor DNA","2026-06-19",{"date":130,"type":54},"2026-06-23",{"date":132,"type":54},"2019-01-17",{"date":134,"type":21},"2026-12-17",{"name":136,"class":61},"University Health Network, Toronto",{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":62},"100479702","individualized-prehabilitation-for-enhancing-recovery-and-surgical-outcomes-in-patients-undergoing-radiotherapy-and-surgery-for-soft-tissue-sarcoma-100479702","NCT05526417","Individualized Prehabilitation for Enhancing Recovery and Surgical Outcomes in Patients Undergoing Radiotherapy and Surgery for Soft Tissue Sarcoma","Pre-Operative ERAS® (Enhanced Recovery After Surgery): Randomized Feasibility Trial of Implementing Individualized Prehabilitation for People Undergoing Neo-Adjuvant Radiotherapy and Lower Limb Soft-Tissue Sarcoma Surgery","Inclusion Criteria:\n\n* Histologically or cytologically-proven deep soft tissue sarcoma (STS) of the lower extremity\n* Localized\n* Adults, 18 and older\n* All gender types\n* Subjects must be able to provide appropriate consent or have an appropriate representative available to do so\n\nExclusion Criteria:\n\n* Soft tissue sarcomas that are in a superficial location relative to fascia\n* Patients with metastatic disease (distant or nodal)\n* Both and upper and lower extremity involvement",{"count":145,"type":21},33,[95],"This clinical trial evaluates whether patients with deep soft tissue sarcomas who receive a tailored prehabilitation exercise regimen during standard radiotherapy and prior to standard of care surgery have better recovery and surgical outcomes than those who do not. Patients undergoing surgery to soft tissue sarcomas are at high risk for post-operative disability, which is associated with high rates of depression and poor health-related quality of life. Prehabilitation is the practice of exercising before surgery to ensure that the patient is in the best possible condition. It allows patients to prepare their bodies for recovery after surgery, which may result in better surgical outcomes, recovery, and quality of life after surgery.",[34,149,150,151],"Stage I Soft Tissue Sarcoma of the Trunk and Extremities","Stage II Soft Tissue Sarcoma of the Trunk and Extremities","Stage III Soft Tissue Sarcoma of the Trunk and Extremities","2026-06-18",{"date":154,"type":54},"2026-06-22",{"date":156,"type":54},"2022-06-08",{"date":158,"type":21},"2028-06-08",{"name":160,"class":61},"Mayo Clinic",{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":179,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":196},"100613057","phase-1-phase-i-study-of-177lulu-dfc413-in-patients-with-solid-tumors-100613057","NCT07261631","Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors","A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DFC413 and Safety and Imaging Properties of [68Ga]Ga-NNS309 in Patients With Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years with one of the following indications:\n* Locally advanced unresectable or metastatic PDAC, with disease progression following, or intolerance to cytotoxic therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to chemotherapy and targeted therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic HR+\u002FHER2- ductal and lobular breast cancer with disease progression following, or intolerance to, hormone therapy and CDK inhibitor, and at least one additional line of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic triple negative breast cancer (TNBC) with disease progression following, or intolerance to, at least two lines of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to, immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy\n* (Dose expansion only) Locally advanced unresectable or metastatic soft tissue sarcoma (excluding GIST and Kaposi) with disease progression following, or intolerance to, at least one line of systemic therapy\n* Patients must have lesions showing 68Ga-NNS309 uptake\n\nExclusion Criteria:\n\n* Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL, hemoglobin \\\u003C 9 g\u002FdL, or platelet count \\\u003C 100 x 109\u002FL\n* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec\n* eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m2, calculated using CKD-EPI 2021 or measured\n* Unmanageable urinary tract obstruction or urinary incontinence\n* Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy\n* Any prior radioligand therapy\n* Radiation therapy within 4 weeks prior to the first dose of \\[177Lu\\]Lu-DFC413\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":170,"type":21},180,[24],"The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \\[177Lu\\]Lu-DFC413 and safety and imaging properties of \\[68Ga\\]Ga-NNS309 in patients aged ≥ 18 years with solid tumors",[174,175,176,177,178,34],"Pancreatic Ductal Adenocarcinoma","Non-Small Cell Lung Cancer","HR+\u002FHER2- Ductal and Lobular Breast Cancer","Triple Negative Breast Cancer","Colorectal Cancer",[180,181,182,183,184,185],"PDAC","NSCLC","Breast cancer","CRC","STS","Radioligand therapy (RLT)","2026-06-16",{"date":188,"type":54},"2026-06-17",{"date":190,"type":54},"2025-11-24",{"date":192,"type":21},"2029-05-09",{"name":194,"class":195},"Novartis Pharmaceuticals","INDUSTRY",8,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":16,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":62},"100407770","phase-2-toripalimab-combined-with-cavie-regimen-100407770","NCT04589741","Toripalimab Combined With CAV\u002FIE Regimen","A Multicenter, Randomized, Parallel-controlled Phase II Study of Toripalimab Combined With CAV\u002FIE Regimen Versus Chemotherapy Alone in Patients With Advanced or Unresectable Bone and Soft Tissue Sarcoma Who Have Failed Standard Treatment","Inclusion Criteria:\n\n1. Patients voluntarily participated in the study and signed informed consent;\n\n   For all advanced or non resectable bone and soft tissue sarcomas confirmed by pathology, the standard treatment failed or there was no standard treatment. They were mainly synovial sarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma, liposarcoma, fibrosarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undiffertiated sarcoma, bone sarcoma, chondrosarcoma, Ewing's sarcoma, rhabdomyosarcoma, dermatofibrosarcoma protuberans, myofibroblastic sarcoma, malignant solitary fibroma, postradiation sarcoma,etc. But the pathological subtypes without standard treatment can be treated as first-line treatment, including but not limited to radiation-induced sarcoma, dedifferentiated \u002F pleomorphic liposarcoma, clear cell sarcoma, etc., except for the following types: well differentiated liposarcoma, malignant mesothelioma, gastrointestinal stromal tumor, etc;\n2. Advanced patients with unresectable lesions or lymph nodes or distant metastasis assessed by imaging;\n3. In the past three months, there was at least one measurable target lesion according to RECIST version 1.1 standard, and it can be accurately measured by magnetic resonance imaging (MRI) or computer tomography (CT) in at least one direction (the maximum diameter needs to be recorded), with conventional CT ≥ 20 mm or spiral CT ≥ 10 mm.\n4. They were 14-70 years old; ECOG PS score: 0-1; the expected survival time was more than 3 months;\n5. Within 7 days before treatment, the main organ functions met the following criteria:\n\n(1) Blood routine examination standard (without blood transfusion within 14 days)\n\n① Hemoglobin (HB) ≥ 90g \u002F L;\n\n② The absolute value of neutrophil (ANC) ≥ 1.5 × 109 \u002F L;\n\n* Platelet (PLT) ≥ 80 × 109 \u002F L.\n\n  (2) Biochemical examination should meet the following standards:\n  * Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);\n\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5uln; ALT and AST ≤ 5uln with liver metastasis\n* Serum creatinine (CR) ≤ 1.5uln or creatinine clearance rate (CCR) ≥ 60ml \u002F min;\n\n  (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value (50%).\n\n  6)Women of childbearing age should agree that contraceptive measures (such as intrauterine device, contraceptive or condom) must be used during the study period and within 6 months after the end of the study; serum or urine pregnancy test negative within 7 days before study enrollment, and must be non lactating patients; men should agree that contraceptive measures must be used during the study period and within 6 months after the end of the study period.\n\nExclusion Criteria:\n\n1\\) Patients who had previously received anti-PD-1 \u002F PD-L1 antibody therapy.\n\n2\\) Other malignancies occurred or were present within 5 years, except for cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \\[ta (non invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\\];\n\n3\\) Systemic anti-tumor therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks prior to the trial drug treatment) was planned within 4 weeks before enrollment or during the study period. Over extended field radiotherapy was performed within 4 weeks before admission or limited field radiotherapy was performed within 2 weeks before grouping;\n\n4\\) With pleural effusion or ascites, it causes respiratory syndrome (≥ CTC AE grade 2 dyspnea \\[grade 2 dyspnea refers to shortness of breath with a small amount of activity; it affects instrumental activities of daily living\\]);\n\n5\\) Any unrelieved toxic reaction higher than CTC AE (4.01) grade 1 or above caused by previous treatment, excluding alopecia;\n\n6\\) Patients with any severe and \u002F or uncontrolled disease, including:\n\n1. Patients with poor blood pressure control (SBP ≥ 150 mmHg, DBP ≥ 100 mmHg);\n2. Patients with myocardial ischemia or myocardial infarction of grade I or above, arrhythmia (including QTc ≥ 480ms) and congestive heart failure (NYHA) grade ≥ 2;\n3. Active or uncontrolled severe infection (≥ CTC AE Level 2 infection);\n4. Chronic liver disease, decompensated liver disease or decompensated hepatitis;\n5. Renal failure needs hemodialysis or peritoneal dialysis;\n6. Poor control of diabetes mellitus (FBG \\> 10mmol \u002F L);\n7. Urine routine examination showed that urine protein was ≥ + +, and 24-hour urine protein was more than 1.0 G;\n8. Patients with epilepsy and need treatment;\n\n7\\) Major surgical treatment, open biopsy or obvious traumatic injury were performed within 28 days before admission;\n\n8\\) Patients with any physical signs or history of bleeding regardless of severity; patients with any bleeding or bleeding events ≥ CTCAE 3 within 4 weeks before enrollment had unhealed wounds, ulcers or fractures;\n\n9\\) Patients who had AVT events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;\n\n10\\) There were active ulcer, intestinal perforation and intestinal obstruction;\n\n11\\) Subjects with clinical symptoms of central nervous system metastasis (such as brain edema, need for hormone intervention, or brain metastasis progression); patients who have previously received treatment for brain or meningeal metastasis, such as clinical stability (MRI) for at least 2 months, and who have stopped systemic hormone therapy (dose \\> 10mg \u002F day, prednisone or other effective hormones) for more than 2 weeks can be included;\n\n12\\) The subjects were using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve the purpose of immunosuppression (dosage \\> 10mg \u002F D, prednisone or other effective hormones), and continued to use them within 2 weeks before enrollment;\n\n13\\) Subjects with any active autoimmune disease or history of autoimmune diseases (e.g., but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; if the subject has vitiligo or asthma has been completely relieved in childhood, it is not necessary to be an adult Any intervention can be included; asthma patients who need bronchodilator for medical intervention cannot be included);\n\n14\\) The subjects had active tuberculosis;\n\n15\\) According to the judgment of the researcher, the subjects are not suitable to be enrolled or there are other factors that may lead to termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which will affect the safety of the subjects, or the collection of test data and samples;\n\n16\\) Patients who participated in other clinical trials of anti-tumor drugs within 28 days before enrollment.","14 Years","70 Years",{"count":207,"type":21},134,[25],"The aim of this study was to investigate the efficacy and safety of CAV\u002FIE chemotherapy combined with toripalimab versus CAV\u002FIE chemotherapy alone in the treatment of patients with advanced or unresectable bone and soft tissue sarcomas who failed in standard treatment.",[34],"2026-06-10",{"date":213,"type":54},"2026-06-12",{"date":215,"type":54},"2020-10-23",{"date":217,"type":21},"2027-06-30",{"name":219,"class":61},"Sun Yat-sen University",{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":62},"100522841","phase-2-5-day-preoperative-radiation-for-soft-tissue-sarcoma-100522841","NCT06087861","5-Day Preoperative Radiation for Soft Tissue Sarcoma","Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum.\n2. Has been offered preoperative radiation and surgery as part of standard-of-care treatment\n3. Age ≥ 18\n4. KPS ≥ 70 or ECOG 0 to 2\n5. Life expectancy ≥ 6 months\n6. If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented.\n7. Ability to understand and the willingness to personally sign the written IRB approved informed consent document.\n\nExclusion Criteria:\n\n1. History of prior radiation to the area to be treated.\n2. Active use of other anti-cancer investigational agents.\n3. Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery).\n4. Pregnancy.",{"count":5,"type":21},[25],"The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.",[34],"2026-06-08",{"date":211,"type":54},{"date":234,"type":54},"2023-10-06",{"date":236,"type":21},"2029-12",{"name":238,"class":61},"Stanford University",{"id":240,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":26,"conditions":243,"keywords":244,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":249,"leadSponsor":250,"locationsCount":62},"100439284",{"count":20,"type":21},[24,25],[28,29,30,31,32,33,34,35,36],[38,39,40,41,42,43,44,45,46,47,48,49],"2026-06-04",{"date":247,"type":54},"2026-06-05",{"date":56,"type":54},{"date":58,"type":21},{"name":60,"class":61},{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":62},"100638426","early-phase-1-feasibility-study-on-the-effect-of-a-methionine-reduced-diet-on-serum-levels-in-pts-w-solid-tumors-100638426","NCT07628634","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w\u002F Solid Tumors","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age: Subjects must be 18 years of age or older.\n* Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.\n* Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.\n* Performance Status: Subjects must have an ECOG performance status of 0-2.\n* Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.\n* Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n* Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.\n* Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.\n* Able to receive systemic standard of care cancer therapy.\n\nAdditional criteria specifically for the glioma population:\n\n* Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.\n* Treatment: Subjects must be able to receive radiation therapy and\u002For chemotherapy as a part of their treatment.\n\nExclusion Criteria:\n\n* Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.\n* Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.\n* Significant Amino Acid\u002FMetabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.\n* Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)\n* Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.\n* Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.\n* Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.\n* Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* Subjects with chronic kidney disease with advanced stages 3b or higher.\n* Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.\n* Subjects with known allergies or intolerances to low-methionine foods.\n* Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.",{"count":7,"type":21},[260],"EARLY_PHASE1","This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.",[263,264,265,266,267,101,34,100,99,268,74,269,270,271,272],"Adenocarcinoma","Basal Cell Carcinoma","Squamous Cell Carcinoma","Transitional Cell Carcinoma","Ductal Carcinoma","Leiomyosarcoma","Germ Cell Tumor","Lymphoma","Endocrine Tumor","Glioma","2026-06-02",{"date":247,"type":54},{"date":276,"type":54},"2026-05-01",{"date":278,"type":21},"2028-05-01",{"name":280,"class":61},"University of California, Irvine",{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":16,"minAge":289,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":309},"100517793","phase-2-a-study-to-evaluate-pre-operative-hypofractionated-radiation-therapy-in-aged--70-years-old-or-fragile--65-years-patients-with-limb-or-trunk-soft-tissue-sarcoma-100517793","NCT06022159","A Study to Evaluate Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or \"Fragile\" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.","Phase II Study Evaluating Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years) or \"Fragile\" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.","HYPOSARC","Inclusion Criteria:\n\n1. Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk.\n2. Indication for neo-adjuvant or adjuvant radiotherapy.\n3. Patient aged ≥ 70 years with a performance status ECOG ≤ 2 and\u002For aged 65 to 70 years with an ECOG of 2 and identified by the investigator as \"fragile\".\n4. Patient affiliated to a Social Health Insurance in France.\n5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures.\n\nExclusion Criteria:\n\n1. Retroperitoneal, ORL and visceral sarcomas.\n2. Previous radiotherapy in the area.\n3. Metastatic disease.\n4. Concomitant or sequential chemotherapy.\n5. Patient requiring total surgery (amputation).\n6. Other cancer under treatment.\n7. Any condition or pathology contraindicating MRI.\n8. Any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure.\n9. Patients included in another therapeutic interventional trial.\n10. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).","65 Years",{"count":291,"type":21},48,[25],"This is a phase II, multicenter, non-randomized study.\n\nThe main objective is to evaluate the treatment with hypofractionated radiation therapy in neo-adjuvant situations on wound healing in a population of aged patients (≥ 70 years old) or ≥ 65 years of age defined as \"fragile\" and treated for soft tissue sarcoma.\n\nA maximum of 48 evaluable patients will be included in this study. The patients will receive an hypofractionated radiation therapy prior to conservative surgery.\n\nEach patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery).",[34],[34,296,297,298,299,300],"Limb soft tissue SARComa","Trunk soft tissue SARComa","Aged population","\"Fragile\" population","hypofractionated radiation therapy","2026-05-29",{"date":273,"type":54},{"date":304,"type":54},"2023-11-28",{"date":306,"type":21},"2029-05",{"name":308,"class":61},"Institut Claudius Regaud",11,{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":318,"briefSummary":319,"conditions":320,"keywords":325,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":62},"100638252","preoperative-immunonutrition-in-patients-with-bone-and-soft-tissue-sarcomas-100638252","NCT07609329","Preoperative Immunonutrition in Patients With Bone and Soft Tissue Sarcomas","Effect of Preoperative Immunomodulatory Nutritional Intervention on Postoperative Complications and Sarcopenia in Patients With Bone and Soft Tissue Sarcomas","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n* Adult patients aged 18 years or older.\n* Histologically confirmed bone sarcoma or soft tissue sarcoma.\n* Localized or oligometastatic disease.\n* Indicated for planned orthopedic tumor resection.\n* Preoperative interval allowing administration of the nutritional intervention for at least 7 days, with 14 days preferred when clinically feasible.\n* Ability to receive oral nutritional supplementation.\n* Signed informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Participants will be excluded if any of the following criteria are present:\n* Indication for urgent surgery.\n* Disseminated disease with more than five metastases.\n* Ongoing parenteral nutrition before study enrollment.\n* Inability to receive oral intake.\n* Severe hepatic failure.\n* Severe renal failure.",{"count":93,"type":21},[95],"This study will evaluate whether a short nutritional intervention before surgery can improve recovery in patients with bone and soft tissue sarcomas.\n\nPatients with these tumors often have a higher risk of poor nutrition and loss of muscle mass. These problems may increase the risk of complications after major orthopedic surgery.\n\nParticipants will be randomly assigned to one of two groups. One group will receive a special oral nutritional supplement twice daily before surgery, in addition to standard care. The other group will receive standard care without the preoperative nutritional supplement.\n\nThe main aim of the study is to compare the rate of clinically relevant postoperative complications within 30 days after surgery. The study will also evaluate changes in muscle mass on CT scans, blood markers of nutrition and inflammation, nutritional risk, functional status, length of hospital stay, and tolerance of the nutritional supplement.",[321,34,322,323,324],"Bone Sarcoma","Sarcopenia","Malnutrition","Postoperative Complications",[326,327,328,323,329,330,322],"Sarcoma","Bone sarcoma","Soft tissue sarcoma","Preoperative Nutrition","Immunonutrition","2026-05-19",{"date":333,"type":54},"2026-05-27",{"date":335,"type":54},"2026-04-01",{"date":337,"type":21},"2028-12-31",{"name":339,"class":61},"St. Anne's University Hospital Brno, Czech Republic",{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":62},"100596774","phase-2-saturn-sts-phase-ii-study-of-neoadjuvant-atezolizumab-with-doxorubicin-concurrent-atezolizumab-with-pre-operative-radiation-therapy-and-adjuvant-atezolizumab-in-patients-with-high-risk-surgically-resectable-extremity-and-truncal-soft-tissue-sarcoma-100596774","NCT07049848","SATURN-STS: Phase II Study of Neoadjuvant Atezolizumab With Doxorubicin, Concurrent Atezolizumab With Pre-operative Radiation Therapy and Adjuvant Atezolizumab in Patients With High-risk Surgically Resectable Extremity and Truncal Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Adult subjects (Age ≥18 years) with treatment-naïve de novo or locally recurrent soft tissue sarcomas of the extremity or superficial trunk\n* Histological diagnosis of grade 2 or grade 3 undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma (MFS), de-differentiated\u002Fpleomorphic liposarcoma (DDLPS), unclassified sarcoma, and leiomyosarcoma. Pathologic terms for the \"unclassified sarcoma\" histology may include pleomorphic undifferentiated sarcoma, unclassified spindle cell sarcoma, spindle cell sarcoma not otherwise specified, pleomorphic spindle cell sarcoma, or pleomorphic fibroblastic sarcoma.\n* Patient must have recent imaging (CT or MRI, as appropriate) within 8 weeks of trial enrollment demonstrating measurable disease, defined as at least one lesion that can be ccurately measured in at least one dimension (longest diameter to be recorded) as \\>5 cm.\n* Patients must have disease determined to be surgically resectable and candidates for upfront surgery as agreed upon by a multidisciplinary consensus (Surgical Oncology, Medical Oncology, Radiation Oncology) after presentation at sarcoma multidisciplinary conference. Resectable tumors are defined as having no significant vascular, neural, or bony involvement. Only cases where a complete surgical resection can safely be achieved are defined as resectable.\n* Patients must have life expectancy \\> 6 months.\n* ECOG performance status ≤2 (Karnofsky ≥60%)\n* For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Patients must have adequate organ and marrow function as defined below:\n\nabsolute neutrophil count ≥1,000\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN creatinine ≤ eGFR ≥40 ml\u002Fmin\n\n* Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200\u002FL, and have an undetectable viral load\n* Negative hepatitis B surface antigen (HBsAg) test at screening (if relevant)\n* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening (if relevant)\n\n  a. The HCV RNA test must be performed for patients who have a positive HCV antibody test.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* The effects of Atezolizumab on the developing human fetus are unknown. For this reason and because doxorubicin as used in this trial is known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy #\n\nCLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range)\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\n  * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:\n  * Women must remain abstinent or use contraceptive methods with a failure rate of 1% per year during the treatment period and for 5 months after the final dose of atezolizumab after the final dose of doxorubicin. Women must refrain from donating eggs during this same period.\n  * A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a woman with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n\n    a. Examples of contraceptive methods with a failure rate of 1% per year include: i. bilateral tubal ligation ii. male sterilization iii. hormonal contraceptives that inhibit ovulation iv. hormone-releasing intrauterine devices v. copper intrauterine devices.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n  * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Disease that is considered surgically unresectable, including, but not limited to significant vascular, neural, or bone involvement, and in cases where a complete surgical resection cannot be safely performed.\n* Prior chemotherapy or targeted small molecule therapy for the current sarcoma. History of previous systemic treatments for other cancers is allowable. This exclusion criteria also applies to patients who present with locally recurrent disease.\n* Prior treatment with radiotherapy to the site of the sarcoma (re-irradiation or radiationinduced sarcomas are not allowed on this study)\n* Metastatic disease or regional lymph node involvement. Chest CT will be mandatory prior to enrollment to evaluate for the presence of metastatic disease. Pulmonary nodule(s) \\\u003C 7 mm without a histological diagnosis may not be the basis for studyexclusion giventhelackof specificityof chest CT.If pulmonary nodule(s) measuring 6 - 10 mm are noted on chest CT but appear stable relative to prior chest imaging of at least 6 months duration or if 18FDG-PET scan indicates that the nodule(s) are unlikely to be metastatic disease, then this is permitted. Pulmonary nodules \\>10 mm should be considered metastatic unless proven otherwise by biopsy\u002Fresection or stable appearance for at least 6 months on imaging.\n* Active concurrent second malignancy within 2 years of trial enrollment. Note: 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. Examples include non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug within 8 weeks of trial enrollment.\n* Prior or concurrent immunotherapy, including treatment with an anti-PD-1, anti-PD-L1, antiPD-L2, or anti-CTLA-4 antibody; tumor vaccines; interferon, or interleukins.\n* Recent stroke or thromboembolic event (within 6 months) requiring anticoagulation that cannot be interrupted. Non- life Threating deep venous thrombosis on stable anticoagulant within 6 months is allowed.\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* Subjects with active, known or suspected autoimmune disease including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis.\n\n  a. Patients with a history of autoimmune-related hypothyroidism who are on thyroidreplacement hormone are eligible for the study.\n* Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n* Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n  1. Rash must cover 10% of body surface area\n  2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n  3. There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Current treatment with anti-viral therapy for HBV\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  1. Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  2. Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Any positive test result for hepatitis B or C virus indicating acute or chronic infection\n* Active tuberculosis\n* History of severe hypersensitivity reaction to any monoclonal antibody\n* Received a live vaccine within 30 days of planned start of study therapy. Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n* Prior allogeneic stem cell or solid organ transplantation\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n* Unwillingness or inability to follow the procedures required in the protocol\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Prisoners or subjects who are involuntarily incarcerated\n* Pregnant women are excluded from this study because doxorubicin a class D agent with the potential for teratogenic or abortifacient effects.\n* Patients weighing \\>400 lbs. as this would disqualify them from undergoing RT (due to physical weight restrictions of the table the patients lie on when being treated with linear accelerators).\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study",{"count":347,"type":21},50,[25],"The goal of this clinical research study is to look at the effectiveness of giving a combination of chemotherapy, immunotherapy, radiation therapy, and surgery to treat soft tissue sarcomas that can be removed by surgery. Researchers want to find out if this treatment combination can extend the time it takes for the disease to relapse (come back after treatment). The safety of this treatment combination will also be studied.",[34],{"date":352,"type":54},"2026-05-22",{"date":354,"type":54},"2025-09-11",{"date":356,"type":21},"2030-01-01",{"name":358,"class":61},"M.D. Anderson Cancer Center",{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":365,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":62},"100431379","phase-1-b7-h3-specific-chimeric-antigen-receptor-autologous-t-cell-therapy-for-pediatric-patients-with-solid-tumors-3car-100431379","NCT04897321","B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)","Inclusion Criteria:\n\nProcurement and T-cell production eligibility\\*\n\n\\*a previously collected, autologous leukapheresis product can be used for T-cell production\n\n* Age ≤21 years old\n* B7-H3+ solid tumor with measurable disease; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using a previously obtained biopsy; a tumor is considered B7-H3 positive with an H-score ≥100\n* Estimated life expectancy of \\>12 weeks\n* Karnofsky or Lansky (age-dependent) performance score ≥50\n* For females of child bearing age:\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Not lactating with intent to breastfeed\n* Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* Known HIV positivity\n* Severe intercurrent bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)\n* History of hypersensitivity reactions to murine protein-containing products\n* Rapidly progressive disease (in the opinion of the study PIs)\n\nInclusion criteria\n\nTreatment eligibility\n\n* Age ≤21 years old\n* B7-H3+ solid tumor with measurable disease\n* Evidence of relapsed or refractory disease after standard first-line therapy\n* Estimated life expectancy of \\>8 weeks\n* Karnofsky or Lansky (age-dependent) performance score≥50\n* Echocardiogram with a ventricular ejection fraction\n* \\>40%; or shortening fraction ≥25%\n* Adequate renal function defined as creatinine clearance or radioisotope GFR 50 ml\u002Fmin\u002F1.73m2 (GFR 40 ml\u002Fmin\u002F1.73m2 if \\\u003C 2 years of age)\n* Adequate pulmonary function defined as pulse oximetry ≥92% on room air or forced vital capacity (FVC) ≥50% of predicted value\n* Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age\n* Hemoglobin≥ 7g\u002FdL (can be transfused)\n* Platelet count \\>50,000\u002FuL (can be transfused)\n* Absolute neutrophil count (ANC) ≥ 1000\u002FuL\n* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy\n* For females of child bearing age:\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Not lactating with intent to breastfeed\n* If sexually active, agreement to use birth control until 3 months after T-cell infusion. Male partners should use a condom.\n* Available autologous transduced T-cell product that has met GMP release criteria\n* Agreement to participate in long-term follow-up protocol for patients, who have received genetically modified cell products\n\nExclusion criteria\n\n* Known primary immunodeficiency\n* History of HIV infection\n* Severe, uncontrolled intercurrent bacterial, viral or fungal infection\n* History of hypersensitivity reactions to murine protein-containing products\n* Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg\u002Fkg\u002Fday of methylprednisolone, in the 7 days prior to B7-H3-CAR T-cell infusion\n* Receiving systemic therapy in the 14 days prior to CAR T-cell infusion, which will interfere with the activity of the B7-H3-CAR product (in the opinion of the study PIs).\n* Rapidly progressing disease (in the opinion of the study PIs)","21 Years",{"count":291,"type":21},[24],"3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed\u002Frefractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors.\n\nPrimary objective\n\nTo determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent\u002Frefractory B7-H3+ solid tumors after lymphodepleting chemotherapy\n\nSecondary objective\n\nTo evaluate the antitumor activity of B7-H3-CAR T cells\n\nExploratory objectives\n\n* To evaluate the tumor environment after treatment with B7-H3-CAR T cells\n* To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells\n* To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells",[370,101,99,371,100,372,373,374,375,376,377,378,74,379,380,34],"Pediatric Solid Tumor","Neuroblastoma","Wilms Tumor","Adrenocortical Cancer","Desmoplastic Small Round Cell Tumor","Germ Cell Cancer","Rhabdoid Tumor","Clear Cell Sarcoma","Hepatoblastoma","Carcinoma","Malignant Peripheral Nerve Sheath Tumors","2026-05-18",{"date":331,"type":54},{"date":384,"type":54},"2022-07-06",{"date":386,"type":21},"2028-03-01",{"name":113,"class":61},{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":196},"100526066","study-assessing-the-effects-of-early-psychiatric-referral-on-mental-health-and-quality-of-life-in-people-with-sarcoma-100526066","NCT06129903","Study Assessing the Effects of Early Psychiatric Referral on Mental Health and Quality of Life in People With Sarcoma","The Effect of Enhanced Behavioral Healthcare on Self-Reported Depression, Anxiety, and Health-Related Quality of Life Among Patients With Musculoskeletal Sarcoma Undergoing Surgery: A Randomized Pilot Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Tissue diagnosis of primary bone or soft tissue sarcoma\n\n  o Note: high suspicion of sarcoma on history and imaging acceptable, if reviewed and approved by the PI\n* Presenting to the Orthopaedic Surgery Service\n* Treatment plan includes surgery at MSK for treatment of the primary sarcoma\n* No previous treatment for sarcoma\n* Proficient in English\n\n  * As determined by use of the Census-LEP question\n  * The patient's response to the question: \"How well do you speak English?\" must be \"very-well\" for inclusion. Additionally, English must be identified as the patient's preferred language for discussing healthcare.\n\nExclusion Criteria:\n\n* Significant psychiatric disturbance determined from self-report and\u002For chart review, sufficient, in the investigator's judgment, to preclude participation in the study\" (e.g., underlying severe mental illness, h\u002Fo suicide attempts, or h\u002Fo psychiatric admissions) Clinical concern at the time of randomization of mental health urgency or emergency requiring evaluation; urgency and emergency will be defined as moderate or high scores, respectively, on the CSSR-S or according to the judgment of the orthopaedic physician evaluating the patient\n* Note: investigators considered exclusion of patients with no or mild symptoms of anxiety and depression, however due to risk of new symptoms arising during the course of treatment, risk of underreporting, risk of under detection, and given prior data on the high prevalence of symptoms, we elected to include all patients in this pilot study.",{"count":396,"type":21},60,[95],"The purpose of this study is to investigate the feasibility of early access to mental healthcare during sarcoma treatment as well as to assess the association between early access to psychiatric care and depression, anxiety, postoperative outcomes, and patient satisfaction in patients undergoing surgery for musculoskeletal sarcoma.",[326,321,34],[326,321,34,401,402,403],"Quality of Life","23-247","Memorial Sloan Kettering Cancer Center","2026-05-13",{"date":406,"type":54},"2026-05-15",{"date":408,"type":54},"2023-11-07",{"date":410,"type":21},"2026-11-07",{"name":403,"class":61},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":434},"100436943","phase-1-a-study-evaluating-the-safety-pharmacokinetics-and-early-efficacy-of-ava6000-in-solid-tumours-100436943","NCT04969835","A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours","A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours","Inclusion Criteria:\n\n1. The patient has been fully informed about the study and has signed the Informed Consent Form.\n2. Male or female patients, ≥ 18 years of age.\n3. a) Phase 1a: patients with tumours reported to be FAP positive with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic:\n\n   a. salivary gland, urothelial, ovarian, or breast carcinoma, who have either relapsed or progressed on SoC treatment or are intolerant or nonamenable to SoC treatment; OR b. soft-tissue sarcoma who: i. is treatment naïve in the locally advanced (unresectable) or metastatic setting and anthracycline naïve (any setting) and would otherwise be a candidate for doxorubicin hydrochloride treatment; OR ii. has received a total doxorubicin dose of \\\u003C 150mg\u002Fm2 (any setting (\\\u003C 2 cycles of 75 mg\u002Fm2 Q21 days) and has discontinued due to intolerance or toxicity related to doxorubicin\n\n   b) Phase 1b: patients with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic tumour of one of the following types:\n   1. High grade soft tissue sarcoma: histologically proven locally advanced or metastatic, unresectable progressive or recurrent DDLS or UPS who have received 0 or 1 prior lines of therapy in the locally advanced or metastatic setting\n   2. SGC: Locally advanced or metastatic salivary gland confirmed by histopathology that cannot be completely resected by surgery who have received 0 or 2 prior lines of therapy in the locally advanced or metastatic setting. In addition, patients with adenoid cystic carcinoma subtypes must not have received prior cytotoxic therapy for locally advanced or metastatic disease. Adenoid cystic carcinoma subtype may be capped at 15 patients (assuming cohort of approximately 30 patients)\n   3. TNBC: Locally advanced or metastatic triple negative breast cancer confirmed by histopathology who have received any prior therapy in the locally advanced or metastatic setting. Patients must be BRCA wild-type.\n4. In Phase 1b, patients must meet the following additional criteria:\n\n   Patients must demonstrate (as documented, per the investigator's assessment), radiological disease progression over the 6 months (±2 months) prior to screening. However, this requirement does not apply if the patient is newly diagnosed, recurrent or newly metastatic.\n   * Patients must have measurable disease per RECIST.\n   * Patients with high grade soft tissue sarcoma or salivary gland cancer must not have previously received an anthracycline-based therapy.\n   * Patients with TNBC may receive up to 250mg\u002Fm2 of prior doxorubicin (or an equivalent anthracycline). Prior anthracycline based therapy must have been completed at least 6 months before the planned Cycle 1 Day 1 AVA6000 infusion. Prior anthracycline use must have been in the adjuvant or neoadjuvant setting only.\n   * Patients must provide at least 1 tissue sample collection, either archival or fresh tissue (approximately 10 slides) unless the biopsy is medically not able to be performed or the principal investigator deems it is not medically feasible.\n5. Has a life expectancy of ≥12 weeks, in the opinion of the investigator.\n6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n7. Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE grade ≤1 or returned to baseline, except alopecia and peripheral neuropathy, which can be up to CTCAE grade 2).\n8. Has adequate haematological function (applies only to patients not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose):\n\n   * Absolute Neutrophil count (ANC) of ≥1.5 × 109 cells\u002FL.\n   * Haemoglobin ≥9.0 g\u002FdL.\n   * Platelet count of ≥75,000\u002FµL.\n   * International normalised ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 times the upper limit of normal (ULN).\n9. Has adequate liver function:\n\n   * Total bilirubin below ULN (except for patients with Gilbert's Syndrome who must have a total bilirubin \\\u003C3 × ULN).\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (in patients with liver metastases, \\\u003C5 × ULN is allowed).\n   * Alkaline phosphatase (ALP) \\\u003C5 × ULN in patients with documented liver or bone metastases, or ALP \\\u003C 2 × ULN in patients without documented metastases.\n10. Has adequate renal function (creatinine clearance ≥50 mL\u002Fmin by Cockcroft-Gault formula) or patients with normal plasmatic creatinine despite creatinine clearance \\\u003C 50 mL\u002Fmin as per Cockcroft-Gault formula are eligible for the study.\n11. Women of childbearing potential (WOCBP) and women who have ≤ 2 years amenorrhea after start of menopause: has a negative serum pregnancy test within 7 days prior to Cycle 1 Day 1.\n12. Contraception requirements:\n\n    * Female patients of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate \\\u003C1% per year) during the treatment period and for at least 6 months after the last dose of study drug.\n    * Male patients with female partners of childbearing potential must agree to using 2 acceptable methods of contraception (Pearl Index failure rate \\\u003C1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug.\n    * Male patients must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.\n13. All patients should have peripheral veins or central line that are, in the opinion of the Investigator or delegate, suitable for peripheral or central intravenous infusion of AVA6000.\n14. The patient is willing and able to comply with the protocol, including any PK blood sampling requirements and agrees to return to hospital for follow-up visits and examinations.\n\nExclusion Criteria:\n\n1. Has received trastuzumab within 7 months of the planned Cycle 1 Day 1 AVA6000 infusion.\n2. Has received a prior total cumulative anthracycline dose of ≥ 350 mg\u002Fm2 doxorubicin (or equivalent anthracycline dose).\n3. Has clinically significant or untreated central nervous system (CNS) metastases or leptomeningeal disease requiring treatment, as determined by the Investigator.\n4. Patients who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal PSA) within 2 years of study entry.\n5. Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.\n6. In the opinion of the investigator, has uncontrolled hypertension (systolic blood pressure \\>150 mm Hg and\u002For diastolic blood pressure \\>100 mm Hg), unstable angina, CHF (New York Heart Association (NYHA) Class \\>II), left ventricular ejection fraction (LVEF) \\\u003C55% or the low limit of institutional normal limit (whichever is lower) by echocardiogram (ECHO), serious cardiac arrhythmia requiring treatment (exceptions include atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months prior to Cycle 1 Day 1, or history of uncontrolled cardiovascular disease or high-sensitivity troponin above normal at baseline (T or I).\n7. Has a screening baseline mean corrected QTcF interval by Fridericia (QTcF) of \\>480 msec. Electrocardiograms (ECGs) will be evaluated locally at the investigator site. Has any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\>250 msec). Has any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, known family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval, a baseline resting bradycardia \\\u003C45 beats\u002Fmin or a baseline resting tachycardia of \\>100 beats\u002Fmin.\n8. HIV infection:\n\n   * Patients with an AIDS-defining infection within 12 months of planned study Day 1.\n   * Patients on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load \\> 400 copies\u002FmL prior to study Day 1.\n9. Active hepatitis B (HBV) or hepatitis C (HCV) infection defined as:\n\n   1. Has a positive hepatitis B surface antigen (HBsAG) test at screening. Patients with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen \\[antiHBc\\] antibody test) are eligible.\n   2. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.\n   3. Chronic HBV (HbSAg positive, undetectable or low HBV DNA and normal ALT).\n   4. Patients with active disease who have not on\u002Finitiated anti-retroviral treatment prior to study Day 1.\n   5. Patients with untreated HCV infection or have not completed treatment for HCV infection.\n   6. Patients with treated HCV infection but with a HCV viral load above the level of quantification.\n10. Has a severe infection (requiring iv treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalisation for complications of infection, bacteraemia, or severe pneumonia.\n11. Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug in the opinion of the investigator.",{"count":420,"type":21},158,[24],"This is a first-in-human (FIH), Phase 1 open-label, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.",[424,425,426,30,34],"Salivary Gland Tumor","Urothelial Carcinoma","Ovarian Carcinoma",{"date":406,"type":54},{"date":429,"type":54},"2021-07-16",{"date":431,"type":21},"2026-08-15",{"name":433,"class":195},"Avacta Life Sciences Ltd",9,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":16,"minAge":442,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":448,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":62},"100596969","phase-1-safety-and-efficacy-of-dit309-in-advanced-bone-and-soft-tissue-sarcomas-100596969","NCT07052383","Safety and Efficacy of DIT309 in Advanced Bone and Soft Tissue Sarcomas","A Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of DIT309 Cell Injection in Subjects With Advanced Bone and Soft Tissue Sarcomas","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the clinical trial; is fully informed about the study and has signed the informed consent form (ICF); is willing and able to comply with all study procedures.\n2. Male or female patients aged ≥8 weeks.\n3. Histologically confirmed diagnosis of advanced bone and soft tissue sarcoma, who have failed or are intolerant to prior standard therapies.\n4. At least one measurable lesion as defined by RECIST version 1.1.\n5. Tumor tissue demonstrates positive expression for the target antigen according to the protocol-defined criteria.\n6. ECOG performance status of 0-1 within 24 hours prior to leukapheresis and prior to lymphodepletion.\n7. Life expectancy of more than 6 months.\n8. Adequate venous access for leukapheresis, with no contraindications for the procedure.\n9. Laboratory parameters must meet the following criteria:\n\n   1. Hematologic function: WBC ≥ 3.0 × 10⁹\u002FL; Hemoglobin ≥ 8.0 g\u002FdL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75.0 × 10⁹\u002FL\n   2. Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n   3. Hepatic function: ALT and AST ≤ 2.5 × ULN (≤ 5.0 × ULN for subjects with liver metastasis)\n   4. Total bilirubin ≤ 2.0 × ULN (excluding patients with Gilbert's syndrome, defined as persistent or recurrent unconjugated hyperbilirubinemia without evidence of hemolysis or hepatic pathology)\n   5. Coagulation: Without anticoagulation therapy, PT, APTT, or INR ≤ 1.5 × ULN\n   6. Negative pregnancy test for female subjects of childbearing potential\n10. Subjects of childbearing potential must agree to use effective contraception from the date of signing the informed consent through 6 months after the last infusion.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women\n2. Viral infections:\n\n   1. Positive serology for HIV antibodies or syphilis\n   2. Positive HBsAg or HBcAb with HBV DNA above the lower limit of detection in peripheral blood\n   3. Positive HCV antibody with detectable HCV RNA in peripheral blood\n3. Medical history and comorbidities:\n\n   1. Known hypersensitivity to DIT309 cells or any component of the investigational products (including fludarabine, cyclophosphamide, or trastuzumab), or history of severe allergic reactions\n   2. Known active autoimmune diseases (e.g., Crohn's disease, systemic lupus erythematosus); subjects with vitiligo or childhood asthma in complete remission and not requiring treatment in adulthood may be eligible; subjects requiring medical intervention such as bronchodilators for asthma are not eligible\n   3. Currently receiving systemic immunosuppressive therapy or anticipated need for long-term immunosuppression during the study (topical, inhaled, or intranasal corticosteroids used intermittently are allowed)\n   4. Prior exposure to any gene-modified T cell therapy (e.g., CAR-T or TCR-T) or any form of gene therapy\\*\n   5. History of uncontrolled neurological or psychiatric disorders that may increase the risk of participation or interfere with study results in the investigator's opinion, including but not limited to epilepsy, dementia, or major depression\n   6. Untreated or symptomatic CNS or leptomeningeal metastases\n   7. Unresolved toxicities from prior treatment that have not recovered to Grade ≤1 per CTCAE v5.0 (except for toxicities deemed not to pose safety risk by the investigator, such as alopecia, Grade 2 peripheral neuropathy, or hypothyroidism managed with replacement therapy)\n   8. History of other primary solid malignancies\n   9. Major surgery or significant trauma within 1 month prior to leukapheresis\n   10. Any serious or uncontrolled comorbidity that, in the investigator's opinion, may increase risks associated with study participation or investigational drug administration, including but not limited to: cardiovascular or cerebrovascular disease, renal insufficiency, pulmonary embolism, coagulation disorders requiring long-term anticoagulation, active or uncontrolled infections requiring systemic treatment.","8 Years",{"count":444,"type":21},15,[24],"This is a open-Label, dose-escalation study to evaluate the safety, tolerability and antitumor activity of DIT309 in subjects with advanced bone and soft tissue sarcomas.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.",[101,34],[449],"Advanced","2026-04-29",{"date":452,"type":54},"2026-05-05",{"date":454,"type":54},"2025-11-06",{"date":456,"type":21},"2027-10-10",{"name":458,"class":195},"Tcelltech Inc.",{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":16,"minAge":465,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":467,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":62},"100487022","phase-1-a-first-in-human-phase-1-trial-of-t-cell-membrane-anchored-tumor-targeted-il12-attil12--t-cell-therapy-in-subjects-with-advancedmetastatic-soft-tissue-and-bone-sarcoma-100487022","NCT05621668","A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced\u002FMetastatic Soft Tissue and Bone Sarcoma","Inclusion criteria:\n\n1. Age .12 years old\n2. Histologically-confirmed locally advanced or metastatic soft tissue or bone sarcoma\n3. Osteosarcoma expansion cohort: histologically confirmed unresectable recurrent\u002Fmetastatic osteosarcoma\n4. Evaluable disease.\n5. Patients must have received at least 1 prior line of systemic therapy for the treatment of sarcoma, unless no standard therapy exists for a specific sarcoma subtype\n6. Prior Cancer Therapy . At least 3 weeks must have elapsed since the last cytotoxic chemotherapy or immunotherapy prior to leukapheresis\u002FPBMC collection.\n\n   * For targeted therapies, at least 4 half-lives or 3 weeks must have elapsed prior to leukapheresis (whichever is shorter).\n7. Standard of care anti-cancer therapy will be permitted following leukapheresis but prior to initiation of cyclophosphamide such that:\n\n   . At least 3 weeks must have elapsed since last cytotoxic chemotherapy or immunotherapy prior to starting treatment with cyclophosphamide.\n\n   . For targeted therapies, at least 4 half-lives or 3 weeks must have elapsed prior to initiation of treatment with cyclophosphamide (whichever is shorter).\n\n   . At least 2 weeks must have elapsed since last radiation therapy prior to cyclophosphamide.\n\n   . Investigational anti-cancer therapy will not be permitted.\n8. ECOG performance status of 0 or 1 (Performance level as measured by Karnofsky for patients . 16 years of age or Lansky for patients \\\u003C 16 years of age, see Appendix B)\n9. Participants must be willing to undergo tumor biopsy\n\n   . Patients in whom biopsy is medically contraindicated or otherwise high risk will not be excluded and may forego research tumor biopsies\n10. Patients must have organ and marrow function as defined below\n11. Absolute neutrophil count (ANC) . 1 K\u002FuL, Hemoglobin . 9 g\u002FdL, Platelets.100 K\u002Fmm3\n12. Serum creatinine . 2 mg\u002FdL OR creatinine clearance \\> 50 mL\u002Fmin\n13. Aspartic transaminase (AST) . 1.5 x upper limit of normal (ULN), Alanine transaminase (ALT) . 1.5 x ULN, Bilirubin . 1.5 x ULN\n14. Cardiac function . LVEF \\>50%\n15. Pulmonary function\n\n    . Oxygen saturation \\>92% on room air\n    * Total lung capacity \\>70% of predicted\n    * DLCO \\>60% of predicted\n16. Women of childbearing potential (WOCBP) must agree to use method(s) of contraception: at least one highly effective or two effective accepted methods of contraception to avoid conception throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal\n17. Men must be willing and able to use an acceptable method of birth control such as latex condom during the dosing period and for at least 3 months after completion of the study agent administration (T cell infusion) if their sexual partners are WOCBP.\n18. Signed Informed Consent and if applicable, pediatric assent\n\nExclusion criteria:\n\n1. Known sensitivity to cyclophosphamide and\u002For study agents Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded\n2. Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression. Subjects previously treated central nervous system metastases that are radiographically and neurologically stable for at least 6 weeks and do not require corticosteroids (of any dose) for symptomatic management for at least 14 days prior to first dose of attIL12-T cells are permitted to enroll. 3. Presence of metastatic disease in or near vital or critical structures that in the judgement of the treating physician in communication with PI or their delegate may lead to concern of immediate risk for harm from the inflammatory response.\n\n4\\. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment at the time of leukapheresis or attIL12 T cell infusion.\n\n1. Standard of care anti-cancer therapy will be permitted following leukapheresis and prior to initiation of cyclophosphamide as bridging therapy (per section 12.4.1).\n2. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.\n3. In addition, local treatment (eg, by local surgery, radiotherapy, or ablation) of isolated lesions for palliative intent is acceptable beyond 30 days following attIL12 T cell administration with prior consultation and in agreement with the PI.\n4. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5 Grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (eg, hearing loss) after consultation with the PI.\n5. Investigational therapy for supportive care (e.g. COVID vaccine) will be permitted, as long as it is reviewed and discussed with the PI.\n\n   5\\. History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis.\n\n   6\\. Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products 7. Major surgery (as defined by the investigator) within 4 weeks prior to first dose of treatment or if still recovering from prior surgery. Biopsy as per study protocol is allowed 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from the study agents, or compromise the ability of the subject to give written informed consent.\n\n   9\\. Subjects with cognitive impairment, including adults with cognitive impairment such as trisomy 21 or similar conditions are not specifically excluded from participation, such that appropriate written informed consent is obtained from the parent or legal guardian and they are able to complete with the study protocol requirements and treatment.\n\n   10\\. Active concurrent second malignancy 11. Pregnant or lactating women 12. Any positive test result for hepatitis B or C virus indicating acute or chronic infection 13. Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome","12 Years",{"count":122,"type":21},[24],"To find a recommended dose of attIL2-T cell therapy that can be given to patients with soft tissue or bone sarcomas and to see if it can help to control the disease.",[34,321],"2026-04-28",{"date":472,"type":54},"2026-05-04",{"date":474,"type":54},"2023-09-08",{"date":476,"type":21},"2027-09-30",{"name":358,"class":61},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":62},"100611672","phase-2-efficacy-and-safety-of-envafolimab-plus-doxorubicin-and-ifosfamide-for-advanced-soft-tissue-sarcoma-100611672","NCT07243626","Efficacy and Safety of Envafolimab Plus Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma","Efficacy and Safety of Envafolimab Combined With Doxorubicin and Ifosfamide as First-line Treatment for Advanced Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Pathologically confirmed advanced soft tissue sarcoma with at least one measurable lesion.\n2. No previous systemic treatment.\n3. ≥18 years old; expected survival time more than 3 months;\n4. Major organ function within 7 days before treatment, meeting the following criteria:\n\n(1) Routine blood test criteria (without blood transfusion within 14 days):\n\n* Hemoglobin (HB) ≥90g\u002FL; ② Absolute neutrophil count (ANC) ≥1.5×109\u002FL; ③ Platelet count (PLT) ≥80×109\u002FL. (2) Biochemical examinations must meet the following criteria: ① Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); ② Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 ULN. If liver metastasis is present, ALT and AST ≤ 5 ULN; ③ Serum creatinine (Cr) ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60ml\u002Fmin; (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%). 5. Women of childbearing age must agree to use contraceptive measures (such as intrauterine devices, birth control pills or condoms) during the study and within 6 months after the study; serum or urine pregnancy tests must be negative within 7 days before study enrollment, and the patients must not be breastfeeding; men must agree to use contraceptive measures during the study and within 6 months after the study.\n\nExclusion Criteria:\n\n1. Chondrosarcoma (CS), osteosarcoma (OS), Ewing's sarcoma, dermatofibrosarcoma protuberans (DFSP), and gastrointestinal stromal sarcoma (GIST) are excluded;\n2. Pregnant or lactating women, or women of childbearing potential who are not using contraceptive measures;\n3. Current severe, uncontrolled acute infection; or purulent or chronic infection with a persistent wound;\n4. Presence of a second primary tumor (excluding basal cell carcinoma of the skin);\n5. Participation in other drug clinical trials within 4 weeks;\n6. Presence of severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction, severe valvular heart disease, and refractory hypertension;\n7. Suffering from uncontrolled neurological, psychiatric, or mental disorders, poor compliance, and inability to match the medication. Patients with uncontrolled primary brain tumors or central nervous system metastases and significant intracranial hypertension or neuropsychiatric symptoms are excluded.\n8. Evidence of a hereditary bleeding diathesis or coagulopathy.\n9. A history of severe allergic\u002Fanaphylactic reactions to humanized antibodies.\n10. Diagnosed with immunodeficiency or receiving systemic glucocorticoids or any other form of immunosuppressive therapy within 14 days prior to the first dose of the study drug. Physiological doses of glucocorticoids (≤10 mg\u002Fday of prednisone or equivalent) are permitted.\n11. Subjects with active, known, or suspected autoimmune diseases (e.g., interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, including but not limited to these diseases or syndromes) are excluded.",{"count":7,"type":21},[25],"Soft tissue sarcoma (STS) is a rare, highly heterogeneous malignancy with a poor prognosis. The standard first-line treatment for advanced patients is anthracyclines (doxorubicin, A) combined with ifosfamide (I, AI regimen), but the efficacy is limited, and some subtypes do not respond well. Immune checkpoint inhibitors (ICI) have shown potential in specific STS subtypes. Anthracyclines can induce immunogenic cell death and upregulate PD-L1, providing a theoretical basis for combined immunotherapy. Previous studies have shown that ICI combined with chemotherapy (such as pembrolizumab + doxorubicin) is more effective than chemotherapy alone. Envolizumab is the world's first subcutaneously injected PD-L1 single-domain antibody-Fc fusion protein, with significant advantages: (1) small molecular weight (\\~80kDa) and strong tissue penetration; (2) high stability and can be stored at room temperature; (3) convenient subcutaneous injection and good tolerability (Phase II study of MSI-H\u002FdMMR solid tumors ORR 42.7%, grade 3-4 TEAE 15.5%). In 2022, the FDA granted orphan drug designation for the treatment of STS.\n\nThis study aims to evaluate the efficacy (ORR, PFS, OS, etc.) and safety of Envolizumab combined with an AI regimen (doxorubicin + ifosfamide) as a first-line treatment for advanced STS.",[34],"2026-04-21",{"date":491,"type":54},"2026-04-24",{"date":493,"type":54},"2024-09-30",{"date":495,"type":21},"2027-06-01",{"name":497,"class":61},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":22,"phases":507,"briefSummary":508,"conditions":509,"keywords":510,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":62},"100509735","pre-operative-hypofractionated-proton-therapy-100509735","NCT05917301","Pre-operative Hypofractionated Proton Therapy","PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma","PRONTO","Inclusion Criteria:\n\n* Adult patients (≥18 years of age)\n* Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma\n* WHO\u002FECOG status ≤2\n\nExclusion Criteria:\n\n* History of prior local radiation therapy\n* Inability to tolerate treatment position for duration of simulation or treatment\n* Tumor originating in retroperitoneal location\n* Patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy\n* Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators.\n* Confirmed pregnancy.",{"count":122,"type":21},[95],"This study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. As part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. The study will measure wound complications and functional outcomes \u002F quality of life after the procedures.\n\nPatients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. Otherwise, the participants will have standard of care follow ups with the treatment team.",[34],[511,45,512],"proton therapy","hypofractionated","2026-04-15",{"date":515,"type":54},"2026-04-17",{"date":517,"type":54},"2024-04-18",{"date":519,"type":21},"2032-12",{"name":521,"class":61},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":541,"leadSponsor":543,"locationsCount":62},"100614756","phase-2-phase-2-trial-of-zanzalintinib-and-pembrolizumab-in-select-subtypes-of-advancedmetastatic-soft-tissue-sarcoma-100614756","NCT07283731","Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced\u002FMetastatic Soft-tissue Sarcoma","Eligibility Criteria\n\n* Participants must have histologically or cytologically confirmed undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma (MFS), high grade pleomorphic (HGPS) or undifferentiated sarcoma (HGUS).\n* Participant ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of zanzalintinib in combination with pembrolizumab in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤2 (Karnofsky ≥60%).\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.\n* At least 4 weeks since prior chemotherapy.\n* At least 2 weeks since radiation therapy for bone metastases, any other radiation therapy within 4 weeks before first dose of study treatment. At least 6 weeks since systemic treatment with radionuclides before first dose of study treatment.\n* Participants must have adequate organ and marrow function as defined below within 14 days before first dose of study treatment:\n\nabsolute neutrophil count ≥1,500\u002FmcL without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection.\n\nplatelets ≥100,000\u002FmcL without transfusion within 2 weeks of screening laboratory sample collection.\n\nhemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL) without transfusion within 2 weeks prior to screening laboratory sample collection.\n\ninternational normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN ).\n\ntotal bilirubin ≤ 1.5 x institutional ULN AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN Alkaline phosphatase (ALP) ≤3 × institutional ULN, . For subjects with documented bone metastasis ALP ≤ 5 x ULN.\n\ncreatinine ≤ 1.5 x institutional ULN or calculated creatinine clearance ≥ 40 mL\u002Fmin (≥ 0.67 mL\u002Fsec) using the Cockcroft Gault equation.\n\nUrine protein-to-creatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol)\n\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 4 weeks. Note: Participants must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).\n* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first three cycles of therapy.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* The effects of zanzalintinib and pembrolizumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n  o Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n\n  o History of hysterectomy or bilateral salpingo-oophorectomy.\n\n  o Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n  o History of bilateral tubal ligation or another surgical sterilization procedure.\n\n  o Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n* Females must not be pregnant.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject\u002Fpartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Women of childbearing potential must comply for the duration of study participation and through 186 days after the last dose of zanzalintinib and 180 days after the last dose of pembrolizumab, whichever date is later. Men must comply for the duration of study participation and through 96 days after the last dose of zanzalintinib or 96 days of pembrolizumab, whichever date is later.\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n* Consent to MD Anderson companion laboratory protocol 2014-0938 for correlative analyses of biopsies obtained in this trial.\n\nExclusion Criteria\n\n* Prior treatment with immune checkpoint inhibitors (ICIs)\n* Prior treatment with zanzalintinib\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible. Additionally, if participants have received radiation therapy within 4 weeks or systemic therapy with radionucleotides within 6 weeks they are not eligible.\n* Participants who are receiving any other investigational agents, as well as cytotoxic or biological systemic anticancer therapy including investigational treatments within 4 weeks of initiating study treatment are excluded.\n* Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors) and platelet inhibitors (eg, clopidogrel).\n\n  * Allowed anticoagulants are the following:\n\n    1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n    2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\nNote: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.\n\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\nUnstable of deteriorating cardiovascular disorders • Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsade's de pointes).\n\n* Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n* Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before first dose of study treatment.\n* Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.\n\nNote: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\nNote: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n\no Prior history of myocarditis.\n\nGastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n* Tumors invading the GI-tract from external viscera.\n* Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.\n* Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic.\n* Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n* Known gastric or esophageal varices.\n* Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks.\n\n  * Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n  * Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n  * Tumors invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Note: Subjects with intravascular tumor extension (eg, tumor thrombus in renal vein or inferior vena cava) may be eligible following Principal Investigator approval.\n  * Other clinically significant disorders that would preclude safe study participation.\n* Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.\n* Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n* Malabsorption syndrome.\n* Pharmacologically uncompensated, symptomatic hypothyroidism.\n* Moderate to severe hepatic impairment (Child-Pugh B or C).\n* Requirement for hemodialysis or peritoneal dialysis.\n* History of solid organ or allogeneic stem cell transplant.\n\n  * Participants with brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 3 months.\n  * History of allergic reactions attributed to compounds of similar chemical or biologic composition to zanzalintinib or pembrolizumab or other agents used in study.\n  * Moderate or strong CYP3A4 inhibitors (see section 5.4).\n  * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load and CD4+ T cell count ≥ 200\u002FµL within 6 months are eligible for this trial.\n* Note: To be eligible, participants taking CYP inhibitors (eg, zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose. Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.\n\n  * Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n  * Pregnant women are excluded from this study because zanzalintinib has the potential for teratogenic or abortifacient effects based on its mechanism of action. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with zanzalintinib and pembrolizumab, breastfeeding should be discontinued if the mother is treated with either agent. These potential risks may also apply the other agents used in this study.\n  * Major surgery (as defined in Appendix 2) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (ie nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (eg, simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment.\n\nNote: Fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n\n• Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.\n\nNote: Triplicate ECG evaluations one minute apart will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n\n* Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.\n* Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to Investigational Product, within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* Suspected autoimmune disease, or active or prior documented autoimmune disease within the last 2 years.\n\nNote: Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n\n* Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Free thyroxine (FT4) outside the laboratory normal reference range. Asymptomatic subjects with FT4 abnormalities can be eligible after Principal Investigator approval.\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\> 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. Inhaled, intranasal, intraarticular, and topical corticosteroids and mineralocorticoids are allowed. Note: Adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Transient short-term use of higher doses of systemic corticosteroids for allergic conditions (eg, contrast allergy) is also allowed.\n* Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.\n* Other conditions, which in the opinion of the Investigator, would compromise the safety of the participant or the participant's ability to complete the study.",{"count":529,"type":21},20,[25],"To learn if zanzalintinib and pembrolizumab can help to control select subtypes of advanced\u002Fmetastatic soft-tissue sarcoma (UPS, MFS, HGPS, and HGUS",[533,534,535,536,537],"Phase 2","Zanzalintinib","Pembrolizumab","Advanced\u002FMetastatic","Soft-Tissue Sarcoma","2026-04-14",{"date":515,"type":54},{"date":273,"type":21},{"date":542,"type":21},"2030-11-01",{"name":358,"class":61},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":22,"phases":553,"briefSummary":554,"conditions":555,"keywords":558,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":62},"100406791","phase-1-retifanlimab-anti-pd-1-antibody-with-gemcitabine-and-docetaxel-in-patients-with-advanced-soft-tissue-sarcoma-100406791","NCT04577014","Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma","A Multi-cohort Study of Retifanlimab With or Without Gemcitabine and Docetaxel in Patients With Advanced Sarcoma","Inclusion Criteria:\n\n* Diagnosis of metastatic or locally advanced and unresectable high-grade soft tissue sarcoma. Unresectable is defined as:\n\n  1. primary tumor cannot be safely removed surgically, or\n  2. primary tumor would benefit from systemic therapy prior to a surgical approach\n* Be willing and able to provide written informed consent\n* Must consent to mandatory tumor biopsy (if deemed safe and feasible) for research studies at screening, if archival tissue is not available, and at C1D15, C3D15.\n* Age ≥ 18 years\n* ECOG performance status ≤ 1\n* Presence of measurable disease per RECIST v1.1\n\n  * Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and\u002For pathologically documented tumor progression in that lesion prior to enrollment.\n* No prior systemic therapy (see exclusion criteria, below)\n* Negative serum pregnancy test in women of childbearing potential\n* Patients with chronic HBV (HBsAg-positive with undetectable or low HBV DNA and normal ALT, or HBsAg-negative with anti-HBc-positive serology) and HCV (completed curative antiviral treatment with HCV viral load below the limit of quantification) may be eligible\n\n  * Patients with HBV should be treated with suppressive antiviral therapy prior to enrollment\n  * Patients with HCV must have completed curative therapy and have negative HCV viral load\n* Adequate organ function, as defined in Table 2:\n\nTable 2: Laboratory Parameters Required for Study Inclusion\n\nHematological Absolute neutrophil count (ANC): ≥ 1,500 \u002FmcL Platelets: ≥ 75,000 \u002F mcL Hemoglobin: ≥ 9g\u002FdL or ≥ 5.6 mmol\u002FL\n\nRenal Serum creatinine: ≤ 1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance: ≥ 60 mL\u002Fmin for patient with creatinine levels \\> 1.5 X institutional ULN (GFR can also be used in place of creatinine orCrCl)\n\nHepatic Serum total bilirubin: ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 ULN except patients with Gilbert's disease (≤ 3x ULN) AST (SGOT) and ALT (SGPT): ≤ 2.5 X ULN OR ≤ 5 X ULN for patients with liver metastases\n\nExclusion Criteria:\n\n* Received any systemic therapy in the advanced or metastatic setting\n\n  * Adjuvant or neoadjuvant therapies received ≥ 1 year prior to enrollment are permitted\n* Unstable or deteriorating cardiovascular disease within the previous 6 months, including:\n\n  * Unstable angina or myocardial infarction\n  * CVA\u002Fstroke\n  * New York Heart Association \\[NYHA\\] Class III or IV congestive heart failure\n  * Uncontrolled clinically significant arrhythmias\n* Current use of immunosuppressive medication, EXCEPT for the following:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)\n  * Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* Evidence of clinically significant immunosuppression such as the following:\n\n  * Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease\n  * Concurrent opportunistic infection\n  * Receiving systemic immunosuppressive therapy (\\> 2 weeks) including oral steroid doses \\> 10 mg\u002Fday of prednisone or equivalent within 2 months prior to enrollment\n* History or evidence of symptomatic autoimmune disease in past 2 years prior to enrollment.\n\n  * Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease\n* Uncontrolled HIV infection, as defined by one or more of the following:\n\n  * Patients with CD4+ T-cell (CD4+) counts \\\u003C 350 cells\u002FuL\n  * Patients with a history of an opportunistic infection secondary to AIDS\n  * Patients on anti-microbials with drug-drug interactions with the study drugs on this protocol, who cannot be switched to alternative anti-microbials\n  * Patients on antiretroviral therapy \\\u003C 4 weeks\n  * Patients with HIV viral load \\> 400 copies\u002FmL\n* Active Hepatitis B or Hepatitis C\n* Patients who have received a live vaccine within 30 days of the start date of the planned study therapy (with the exception of COVID-19 vaccines)\n* History of active TB (Bacillus Tuberculosis)\n* Radiation therapy within 2 weeks prior to study day 1\n* If patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy\n* Women who are pregnant or breast feeding\n* Patients expecting to conceive or father children within the projected duration of the trial, starting with the visit through 180 days after the last dose of study treatment(s)\n* Prior organ transplantation including allogenic stem-cell transplantation\n* Active infection requiring systemic therapy\n* Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3)\n* Patients with prior history of interstitial lung disease and clinically significant pulmonary compromise, including those who have a requirement for supplemental oxygen use to maintain adequate oxygenation",{"count":552,"type":21},98,[24,25],"This study is being done to find out whether the study drug Retifanlimab, a monoclonal antibody against the PD-1 protein, combined with gemcitabine and docetaxel, is a safe and effective treatment for your disease. Gemcitabine and docetaxel are chemotherapy drugs that are commonly used to treat soft tissue sarcoma. Retifanlimab is an experimental drug that boosts the immune system's ability to fight cancer cells. The study researchers think that Retifanlimab may help gemcitabine and docetaxel work better against soft tissue sarcoma that is either locally advanced or has spread beyond its original location (metastasized), and it cannot be removed with surgery (unresectable).",[34,556,326,557],"Sarcoma,Soft Tissue","Soft Tissue Sarcoma Adult",[45,559,560,561,562,563,564,403],"locally advanced soft tissue sarcoma","unresectable soft tissue sarcoma","metastasized soft tissue sarcoma","sarcoma","Retifanlimab","20-316","2026-04-13",{"date":538,"type":54},{"date":568,"type":54},"2020-09-29",{"date":570,"type":21},"2026-09-29",{"name":403,"class":61},{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":22,"phases":582,"briefSummary":583,"conditions":584,"keywords":620,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":196},"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":581,"type":21},28,[25],"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",[585,586,587,588,589,590,591,592,593,594,595,596,597,598,371,599,600,601,602,603,604,605,378,606,268,607,608,609,101,610,611,612,613,614,615,34,616,617,618,31,619],"Urachal Cancer","Parathyroid Carcinoma","Fibrolamellar Carcinoma","Angiosarcoma","Secretory Carcinoma of Breast","Anal Neoplasms","Metaplastic Breast Carcinoma","Translocation Renal Cell Carcinoma","Carcinosarcoma","Small Intestine Neoplasms","Cholangiocarcinoma","Sertoli-Leydig Cell Tumor","Adenoid Cystic Carcinoma","Mesothelioma","Adrenal Gland Neoplasms","Penile Neoplasms","Apocrine Carcinoma","Fibrosarcoma","Cancer of Unknown Primary","Hemangioblastoma","Thyroid Neoplasms","Fallopian Tube Neoplasms","Vaginal Neoplasms","Neurofibrosarcoma","Gallbladder Neoplasms","Biliary Tract Neoplasms","Clear Cell Endometrial Cancer","Yolk Sac Tumor","Vulvar Neoplasms","Kaposi Sarcoma","Ovarian Epithelial Cancer","Urethral Neoplasms","Granulosa Cell Tumor","Primitive Neuroectodermal Tumor","Trophoblastic Tumor",[621,586,622,587,588,623,624,591,625,593,626,595,627,628,629,630,598,371,631,632,601,602,603,604,633,378,634,268,635,608,636,101,637,611,612,638,35,614,615,34,639,617,597,618,31,619],"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","Urethral Cancer","2026-04-10",{"date":513,"type":54},{"date":643,"type":54},"2024-07-16",{"date":645,"type":21},"2028-05",{"name":647,"class":61},"Instituto do Cancer do Estado de São Paulo",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":652,"acronym":4,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":22,"phases":656,"briefSummary":657,"conditions":658,"keywords":659,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":676,"locationsCount":62},"100626494","early-phase-1-application-of-contrast-enhanced-ultrasound-in-monitoring-soft-tissue-sarcoma-response-to-neoadjuvant-radiotherapy-100626494","NCT07436364","Application of Contrast-enhanced Ultrasound in Monitoring Soft Tissue Sarcoma Response to Neoadjuvant Radiotherapy","Inclusion Criteria:\n\n* Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:\n\n  * Provide signed and dated informed consent form\n  * Willing to comply with all study procedures and be available for the duration of the study\n  * Male or female, Male or female, aged ≥18 years of age\n  * Patients with pathologically confirmed STS (Trunk and extremity sarcoma only)\n  * Scheduled for neoadjuvant RT for STS\n\n    o Both standard and hypofractionation schedules are permitted.\n  * Willing to comply with all study procedures and be available for the duration of the study\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  * Pregnancy or lactation\n  * Known allergic reactions to any component of Definity\n  * Has STS that is too large for ultrasound imaging (e.g. its short axis is larger than 10 cm at the depth of 2 cm)\n  * Has other primary cancers requiring systemic treatment.\n  * Has metastatic disease at presentation\n  * Had prior RT to the area",{"count":655,"type":21},10,[260],"This pilot study will evaluate the feasibility of applying CEUS as imaging guidance for planning RT and predicting RT response. The investigators will determine if US-CT\u002FMRI fusion is feasible and if tumor vascularity and pressure from CEUS can be used to reflect\u002Fpredict the RT response.\n\nThe investigators will perform CEUS three times: before the first neoadjuvant RT fraction, halfway through RT, and between the completion of RT and surgery. The fusion will be performed using previously acquired CT\u002FMRI or on-site cone-beam CT with Bmode US. Once the fusion is successful, CEUS will be performed and panoramic 2D images (mimicking 3D) will be collected for the whole tumor. If the fusion is not feasible or successful, the investigators will perform CEUS side by side with CT\u002FMRI and collect images. The investigators will quantify tumoral vascularity comparing Bmode area\u002Fvolume (total tumor) and contrast-enhanced area\u002Fvolume (vascular region) at each time point. Subharmonic amplitudes in the tumor area\u002Fvolume will be quantified to estimate tumoral pressure (known to be the same level as interstitial fluid pressure (IFP)). Quantified vascularity and pressure at each time point will be compared with the tumor size change at later study points as well as the histological outcome after the surgery.",[34],[326,660,661,662,663,664,665,666,667,668,669],"CEUS","Ultrasound Imaging","Definity","ultrasound contrast agent","Subharmonic-aided Pressure Estimation","SHAPE","tumor vascularity","CT","MRI","on-site cone-beam CT","2026-04-09",{"date":538,"type":54},{"date":673,"type":54},"2026-03-23",{"date":675,"type":21},"2027-05",{"name":677,"class":61},"Thomas Jefferson University",{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":682,"acronym":683,"eligibilityCriteria":684,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":685,"targetDuration":4,"studyType":22,"phases":687,"briefSummary":689,"conditions":690,"keywords":691,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":694,"startDateStruct":695,"completionDateStruct":697,"leadSponsor":699,"locationsCount":700},"100386096","phase-3-interest-of-peri-operative-chemotherapy-in-patients-with-cinsarc-high-risk-localized-soft-tissue-sarcoma-100386096","NCT04307277","Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma","CHIC-STS01","Inclusion Criteria:\n\n1. Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network\n2. According to FNCLCC grading system, grade 1, 2 or 3 tumors\n3. Resectable and localized disease after appropriate extension work-up (including at least a chest-CT)\n4. 6 weeks or less between surgical excision and inclusion (if performed before inclusion)\n5. Available archived FFPE tumor sample in sufficient quantity to allow CINSARC qualification\n6. Age ≥ 18 years\n7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n8. Life expectancy of at least 12 weeks after the start of the treatment\n9. Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period and at least 12 months (ifosfamide treatment) or 6 months (dacarbazine treatment) after the end of the treatment period. All non-menopaused women should have a negative pregnancy test within 72 hours prior to registration. Men should accept to use an effective contraception during treatment period and at least 3 months after the end of the study treatment.\n10. Signed written informed consent\n11. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcomas, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, epithelioid sarcoma, alveolar or embryonal rhabdomyosarcoma\n2. Primitive cutaneous, retroperitoneal, uterus or visceral STS\n3. Metastatic disease\n4. Previous or ongoing treatment for the sarcoma (with the exception of surgical excision)\n5. Contra-indication for Doxorubicin, Ifosfamide and Dacarbazine treatments\n6. Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards, and prior therapy with anthracyclines\n7. Prior mediastinal\u002Fcardiac radiotherapy\n8. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia, myocardial infarction within 6 months prior to study entry\n9. Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma\n10. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy\n11. Known infection with HIV, hepatitis B, or hepatitis C\n12. Women who are breastfeeding, pregnant or who plan to become pregnant while in the trial\n13. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study\n14. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)\n15. Patient unable to comply with the protocol for any reason.\n\nADDITIONAL CRITERIA FOR THE RANDOMIZED PHASE III STUDY\n\n1. High-risk CINSARC signature\n2. Acceptable hematologic function (within 72 hours prior randomization): Absolute neutrophil count (ANC) ≥ 1.5 G\u002FL, Platelet count ≥ 100 G\u002FL and Hemoglobin \\> 9g\u002FdL\n3. Acceptable renal function within 72 hours prior randomization: Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL\u002Fmin (by the Cockcroft and Gault formula)\n4. Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN\n5. Normal LVEF (\\>50%) measured by echocardiography or isotopic ventriculography",{"count":686,"type":21},600,[688],"PHASE3","Phase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable STS, considered as high-risk according to CINSARC (Complexity Index in SARComas) signature.\n\nAfter signed informed consent, patients considered as eligible to CHIC-STS study by the investigator will be enrolled in the study and a molecular screening will be performed (600 patients will be screened).\n\nPatients considered as low-risk according to CINSARC signature will be treated at the discretion of the clinicians (prospective cohort).\n\nPatients considered as high-risk according to CINSARC signature will be randomized in the open-label multicenter phase III trial and assigned in one of the two following treatments arms:\n\n* Arm A (control arm): Standard of care (surgical excision +\u002F- external radiotherapy).\n* Arm B (experimental arm): Standard of care + 4 cycles of intravenous chemotherapy during 12 weeks.\n\nA total of 250 patients will have to be randomized with 125 patients in each arm.",[34],[34,692,693],"CINSARC signature","Chemotherapy",{"date":538,"type":54},{"date":696,"type":54},"2020-10-09",{"date":698,"type":21},"2032-10",{"name":308,"class":61},19]