[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sarcoma-of-bone\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sarcoma-of-bone":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,78,112,134],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100560022","phase-2-xl092-zanzalintinib-for-the-treatment-of-patients-with-metastatic-or-unresectable-leiomyosarcoma-bone-sarcoma-or-translocation-associated-soft-tissue-sarcoma-100560022",false,"NCT06571734","XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma","A Non-Randomized, Open-label Phase II Trial Testing the Activity of XL092 (Zanzalintinib) in Patients With Advanced Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma","Inclusion Criteria For Cohort 1 - Leiomyosarcoma:\n\n* Patients must have histologically confirmed leiomyosarcoma that has been clinically determined to be metastatic or unresectable. Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as Northwestern University's Lurie Cancer Center.\n* Patients must have undergone at least 2 or more lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).\n\nInclusion Criteria For Cohort 2 - Bone Sarcoma:\n\n* Patients must have histologically confirmed diagnosis of metastatic or unresectable bone sarcoma. Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as Northwestern University's Lurie Cancer Center.\n* Patients must have undergone at least 1 line of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).\n\nInclusion Criteria For Cohort 3 - Translocation-associated Soft Tissue Sarcoma:\n\n* Patients must have histologically confirmed diagnosis of metastatic or unresectable translocation-associated soft tissue sarcoma (TAS). Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as Northwestern University's Lurie Cancer Center.\n* Patients must have undergone greater than 2 lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).\n\nInclusion Criteria for All Cohorts\u002FSarcoma Types\n\n* Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.\n* Patients must be aged ≥ 18 years on day of signing any informed consent documents.\n* Patients must exhibit a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or \\> 70% on the Karnofsky Scale.\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (without granulocyte colony-stimulating factor support within 21 days of screening sample collection)\n* Hemoglobin (Hgb) ≥ 9 g\u002FdL without transfusion within 21 days of screening laboratory sample collection\n* Platelets (PLT) ≥ 100,000\u002Fmm\\^3 (\\> 100 GI\u002FL) without transfusion within 21 days of screening laboratory sample collection\n* International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal ULN; for patients with Gilbert's disease, total bilirubin ≤ 3 x ULN\n* Alanine aminotransferase (AST) ≤ 3 x institutional ULN\n* Aspartate aminotransferase (ALT) ≤ 3 x institutional ULN\n* Alkaline phosphatase (ALP) ≤ 3 x institutional ULN; for patients with documented bone metastasis, ALP ≤ 5 x ULN\n* Serum creatinine ≤ 1.5 x institutional ULN OR calculated creatinine clearance ≥ 40 mL\u002Fmin ( ≥ 0.67 mL\u002Fsec) using the Cockcroft-Gault equation\n* Creatinine clearance ≥ 40mL\u002Fmin\n* Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg\u002Fmg ( ≤ 113.12 mg\u002Fmmol)\n* Patient of child-bearing potential (POCBP) and any of their partners with sperm-producing reproductive capability must agree to use a highly effective method of contraception throughout the course of the study and for 186 days after the last dose of treatment. Additional contraceptive method, such as a barrier method (e.g., condom) is also required\n* Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence), with partners of childbearing potential from time of informed consent, for the duration of study participation, and for 96 days following completion of therapy\n* Patients must have ejection fraction \\> 50% by either MUGA scan or echocardiogram.\n* Patients must be capable of understanding and complying with the protocol requirements.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who have received previous treatment with XL092.\n* Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to study day 1 treatment.\n* Patients who have received \\> 2 prior tyrosine kinase inhibitor therapies as anticancer treatments.\n* Patients who have had prior chemotherapy, or radiation therapy within 4 weeks prior to start of study treatment unless they have recovered from their prior therapy (toxicity and\u002For complications) such that they now meet all other eligibility criteria\n* Patients who have received radiation therapy for bone metastasis within 14 days prior to registration\n* Patients who have undergone systemic treatment with radionuclides within 6 weeks (42 days) before first dose of study treatment\n* Patients with clinically relevant complications from prior radiation therapy requiring ongoing therapy, per the opinion of the treating investigator enrolling the patient.\n* Patients with a known prior or concurrent malignancy that is progressing or requires active treatment within 2 years of first dose of study treatment. Note: The following exceptions may be made:\n\n  * For patients with malignancies like basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer; or superficial skin cancers, localized low-grade tumors deemed cured and not treated with systemic therapy, and incidentally diagnosed prostate cancer if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n  * For 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.\n* Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed. Note: Eligible patients must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.\n* Patients who are on concomitant anticoagulation therapy with oral anticoagulants (e.g., warfarin or direct thrombin and factor Xa inhibitors) and platelet inhibitors (e.g., clopidogrel). Note: Allowed anticoagulants are low-dose aspirin for cardioprotection (per local applicable guidelines) and low molecular weight heparins (LMWH). Therapeutic doses of LMWH are not permitted in patients with brain metastases. Note: Patients must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first study treatment, whichever is longer.\n* Patients who are taking any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks (14 days) prior to start of treatment. Note: taking complementary medications to treat symptoms of the cancer is allowed.\n* The patient has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes)\n    * Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic of \\> 90 mm Hg diastolic despite optimal antihypertensive treatment\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant ischemic events within 12 months prior to first dose of study treatment. Note: Patients who did not require prior anticoagulant therapy may be eligible must be discussed and approved by the principal investigator (PI)\n    * Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous or non-cerebrovascular accident (CVA)\u002FTIA arterial thromboembolic events within 6 months before to first dose of study treatment.\n    * Prior history of myocarditis\n  * Gastrointestinal (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    * Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess must be confirmed prior to first dose of study treatment\n    * Known gastric or esophageal varices\n    * Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months unless cause of obstruction is definitively managed and subject is asymptomatic\n* Patients with clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 84 days prior to registration.\n* Symptomatic cavitating pulmonary lesions or endobronchial disease (asymptomatic or radiated lesions allowed).\n* Lesions invading major blood vessel including but not limited to inferior vena cava, pulmonary artery, or aorta.\n\nNote: Patients with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior vena cava) may be eligible following PI approval\n\n* Patients who are capable of donating eggs for the purpose of reproduction must not do so throughout the course of the study and for 186 days after the last dose of treatment\n* Patients who are capable of donating sperm for the purpose of reproduction must not do so throughout the course of the study and for 96 days after the last dose of treatment\n* Other clinically significant disorders that would preclude safe study participation, including, but not limited to:\n\n  * Active infection requiring systemic treatment. Note: This criterion applies only at enrollment; if a patient develops an infection while on study treatment, they may continue to receive study treatment. Note: prophylactic antibiotic treatment is allowed\n  * Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness\n  * Known positive test for or suspected infection with SARS-CoV-2 within one month prior to enrollment. Note: Demonstration that the patient has fully recovered from the infection is required to be eligible for enrollment\n  * Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if they are 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 allogenic stem cell transplant\n* Recent surgery within the following parameters:\n\n  * Major surgery (e.g., GI surgery or removal\u002Fbiopsy of brain metastasis) within 8 weeks prior to study treatment\n  * Minor surgery (e.g., simple excision, tooth extraction) within 5 days prior to first dose of study treatment. Note: if a patient has had a recent surgery outside of the proscribed interval, complete wound healing from said surgery must have occurred prior to first dose of study treatment. Note: Fresh tumor biopsies should be performed at least 5 days prior to registration. Patients with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) prior to first dose of study treatment Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility\n* Patients with any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) grade \\> 1 at baseline from a previous anticancer therapy, with the following exceptions:\n\n  * Alopecia, vitiligo, and the laboratory values\n  * Patients with grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the treating physician\n  * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with XL092 may be included only after consultation with the principal investigator\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to XL092\n* Patients who are pregnant (positive serum or urine test within 72 hours prior to enrollment) or nursing. Pregnant people are excluded from this study because XL092 is a next-generation tyrosine kinase inhibitor with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing parent with XL092, breastfeeding should be discontinued if the nursing parent is treated with XL092. Note: If a urine pregnancy test is positive or cannot be confirmed negative, a serum pregnancy test will be required\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, per the opinion of the treating investigator\n* XL092 is administrated orally; patients who are unable to swallow, retain, and\u002For absorb pills are not eligible for this study\n* Patients who are currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of treatment\n* Other conditions which, in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study","ALL","18 Years",{"count":19,"type":20},73,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well zanzalintinib (XL092) works in treating patients with leiomyosarcoma that has spread from where it first started to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Leiomyosarcomas are a type sarcoma that can occur in any location in the body, such as the uterus or in the abdomen. Current standard treatment for leiomyosarcoma only shows a progression-free survival of 4-6 months. XL092, a tyrosine kinase inhibitor, interferes with cell communication and growth and may prevent tumor growth. Giving XL092 may kill more tumor cells in patients with metastatic or unresectable leiomyosarcoma. The trial has now been expanded to treat additional sarcoma types that are sensitive to tyrosine kinase inhibitors (TKIs) such as translocation-associated soft tissue sarcoma (such as synovial sarcoma), and bone sarcoma (including osteosarcoma and Ewing sarcoma).",[26,27,28,29,30,31,32,33,34,35],"Metastatic Leiomyosarcoma","Unresectable Leiomyosarcoma","Bone Sarcoma","Translocation-associated Soft Tissue Sarcoma","Synovial Sarcomas","Osteosarcoma Metastatic","Ewing Sarcoma","Ewing Sarcoma Metastatic","Sarcoma Metastatic","Sarcoma of Bone","RECRUITING","2026-06-16",{"date":39,"type":40},"2026-06-18","ACTUAL",{"date":42,"type":40},"2024-09-19",{"date":44,"type":20},"2033-07-01",{"name":46,"class":47},"Northwestern University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100371937","gisar-german-interdisciplinary-sarcoma-registry-100371937","NCT04122872","GISAR German Interdisciplinary Sarcoma Registry","GISAR","Inclusion Criteria:\n\n* Histological verified bone or soft tissue sarcomas including bone and soft tissue tumors with borderline histological results or with unclear histological dignity like giant cell tumors of the bone (GCTB), desmoid tumors, atypical lipomatous tumors etc. - independent of therapy form and therapy line - or Histological verified sarcomatoid carcinomas\u002F carcinosarcomas: tumors with histological, cytological, or molecular properties of both epithelial tumors (\"carcinoma\") and mesenchymal tumors (\"sarcoma\") - independent of therapy form and therapy line.\n* Signed informed consent form or equivalent (s. chapter 10)\n* Age ≥18 years\n\nExclusion Criteria:\n\n* none",{"count":57,"type":20},9000,"10 Years","OBSERVATIONAL","GISAR has an open and modular setup. It is sought to include as many German sarcoma and CS patients (i.e. sarcoma and CS patients treated in Germany) in the registry as possible. A basic data set should be collected on every included patient). In order to adress specific scientific questions, additionally detailed data can be collected in defined patient groups (e.g. effectiveness \u002F adverse effects of systemic therapies in defined situations) within the context of sub-project add-on modules. This data collection can be prospective or retrospective depending on the sub-project",[62,63,35,64],"Sarcoma","Sarcoma,Soft Tissue","Carcinosarcoma",[62,66,35,67],"Soft Tissue Sarcoma","Registry","2026-02-03",{"date":70,"type":40},"2026-02-05",{"date":72,"type":40},"2018-11-29",{"date":74,"type":20},"2038-01",{"name":76,"class":47},"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest",21,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":48},"100598091","phase-1-sequential-infusion-of-cd146-targeted-and-her2-targeted-car-t-cells-in-patients-with-advanced-sarcomas-100598091","NCT07066982","Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas","A Phase 1\u002F2 Open-Label, Multicenter Trial of Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas","BAH2573-103","Inclusion Criteria:\n\n* Expected survival time ≥3 months;\n* Diagnosis: Histologically or cytologically confirmed sarcoma (soft tissue or bone sarcoma), that is metastatic, locally advanced, or refractory to standard therapy. This may include osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, leiomyosarcoma, or other high-grade sarcomas. Patients must have evidence of measurable disease as per RECIST or applicable criteria.\n* Prior Treatment: Patients should have received and progressed on or not be candidates for standard first-line treatments. There is no limit on number of prior lines of therapy, but at least one prior systemic therapy for sarcoma is typically required (unless no standard therapy exists for the subtype). A minimum wash-out period (e.g. 2 weeks) from previous treatments (chemotherapy, radiation, or other immunotherapy) is required before lymphodepletion.\n* Age and Performance Status: Participants age 12 years and older (both adolescent and adult patients are eligible; for minors, legal guardian consent is required). Upper age limit of \\~75 years, or as determined by medical fitness. ECOG performance status 0-1 (or Karnofsky ≥70% for pediatric patients), indicating subjects are ambulatory and able to perform light work.\n* Organ Function: Adequate organ function to undergo cytotoxic chemotherapy and cell transfer therapy, including: cardiac ejection fraction ≥50%; baseline oxygen saturation \\>92% on room air; adequate bone marrow reserves (absolute neutrophil count ≥1.0×10\\^9\u002FL, platelets ≥75×10\\^9\u002FL, hemoglobin ≥8 g\u002FdL), hepatic function (e.g. bilirubin ≤1.5× ULN, AST\u002FALT ≤2.5× ULN), and renal function (e.g. creatinine clearance ≥50 mL\u002Fmin or age-appropriate normal).\n* Tumor Antigen Expression: Expression of CD146 and\u002For HER2 in the tumor is recommended (as assessed by immunohistochemistry or flow cytometry on a tumor sample). Note: At least one of the target antigens (CD146 or HER2) should be present on the tumor; if feasible, patients should have tumor tissue tested for these markers. (In cases where testing is unavailable, enrollment may proceed based on histology known to often express these targets, per investigator judgment.)\n* Consent: Ability to understand and provide written informed consent (or assent for minors with consent of legal guardian). Patients (or guardians) must be willing to comply with trial procedures and follow-up.\n\nExclusion Criteria:\n\n* Recent Therapies: Prior treatment with any CAR-T cell therapy or other gene-modified T-cell therapy is excluded. Also exclude patients who received any investigational drug, immunotherapy (e.g. checkpoint inhibitor), or major surgery within a certain interval (e.g. 4 weeks) prior to enrollment. Concurrent enrollment in another interventional clinical trial is not allowed.\n* Recent Therapies: Prior treatment with any CAR-T cell therapy or other gene-modified T-cell Infections: Active uncontrolled infection, including active hepatitis B or C infection, or HIV infection with uncontrolled viral load. Patients must not have evidence of active tuberculosis or other severe infections. All patients will be screened for HBV, HCV, and HIV at baseline.\n* Immunosuppression: Use of systemic immunosuppressive medications (such as chronic corticosteroids at \\>10 mg prednisone daily or equivalent) within 7 days prior to leukapheresis. (Physiologic replacement doses of steroids are permitted.) Patients with a history of allogeneic stem cell transplant or solid organ transplant are excluded (due to the need for immunosuppression and risk of graft-versus-host or graft rejection).\n* Medical Comorbidities: Any significant uncontrolled medical condition that would, in the investigator's judgment, make the patient an unsuitable candidate for CAR-T therapy. For example: active autoimmune diseases requiring immunosuppression, clinically significant heart failure (NYHA class III-IV), unstable angina or myocardial infarction within 6 months, severe chronic respiratory disease requiring supplemental oxygen, or psychiatric conditions that would interfere with study participation and follow-up.\n* Pregnancy\u002FBreastfeeding: Women who are pregnant or breastfeeding are excluded due to unknown risks of the treatment to a fetus or infant. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception during the study and for a suitable period after CAR-T infusion (e.g. 1 year), given the potential for sustained CAR T-cell activity. A negative serum pregnancy test is required for females of childbearing potential before starting lymphodepletion.","21 Years","90 Years",{"count":89,"type":20},60,[91,23],"PHASE1","This is an open-label, non-randomized, multicenter Phase 1\u002F2 trial evaluating a dual CAR-T cell therapy targeting CD146 and HER2 in patients with advanced sarcoma. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by sequential infusion of autologous CD146-specific and HER2-specific CAR-T cells. The Phase 1 portion will employ a dose-escalation design to assess safety and determine the recommended Phase 2 dose, while the Phase 2 expansion will evaluate preliminary efficacy (tumor response and survival outcomes). Approximately 40 patients (children and adults) with relapsed or refractory sarcomas will be enrolled across multiple centers. All participants will be followed for up to 36 months to monitor dose-limiting toxicities, objective response rates, progression-free survival, overall survival, and long-term safety.",[62,94,95,63,96,97,34,98,35],"Sarcoma, Kaposi","Sarcoma, Ewing","Sarcoma of Bone and Connective Tissue","Sarcoma, Synovial","Sarcomas, Germinoblastic",[62,100,101,102,35],"CD146","HER2","CAR-T","2025-07-04",{"date":105,"type":40},"2025-07-15",{"date":107,"type":40},"2025-05-29",{"date":109,"type":20},"2028-12-28",{"name":111,"class":47},"Essen Biotech",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":48},"100565040","phase-2-phase-ii-clinical-trial-of-chidamide-combined-with-ak112-for-second-line-and-advanced-bone-and-soft-tissue-sarcoma-100565040","NCT06637007","Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma","Single Arm, Open Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma","Inclusion Criteria:\n\n* The patient voluntarily participated in this study and signed an informed consent form；\n* All advanced bone and soft tissue sarcomas diagnosed by pathology have at least one measurable lesion according to RECIST 1.1 criteria, mainly including synovial sarcoma, smooth muscle sarcoma, vascular sarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, protuberant skin fibrosarcoma, Ewing's sarcoma\u002Fprimary neuroectodermal tumor, connective tissue proliferative small round cell tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroadenoma, chondrosarcoma, osteosarcoma. Except for the following types: malignant mesothelioma, acinar soft tissue sarcoma, gastrointestinal stromal tumor, and extra bone mucinous chondrosarcoma;\n* Patients with advanced bone and soft tissue sarcoma who experience disease progression or failure after first-line standard treatment;\n* 18\\~75 years old; ECOG PS score: 0-1 points; Expected survival period exceeding 3 months;\n* Adequate organ and bone marrow function, no severe hematopoietic dysfunction, heart, lung, liver, kidney, thyroid dysfunction, or immunodeficiency (no blood transfusion, granulocyte colony-stimulating factor, or other related medical support received within 14 days prior to the use of the study drug)；\n* The main organ function meets the following criteria within 7 days before treatment:\n\n  1. Blood routine examination standard (without blood transfusion within 14 days)：\n\n     * hemoglobin（HB）≥90g\u002FL；\n\n       * Absolute Neutrophil Count（ANC）≥1.5×109\u002FL；\n\n         * platelet（PLT）≥80×109\u002FL。\n  2. Biochemical tests must meet the following standards：\n\n     * total bilirubin（TBIL）≤1.5 upper limit of normal (ULN) ；\n\n       * Alanineaminotransferase（ALT）and Aspartic transaminaseAST≤2.5 ULN，If accompanied by liver metastasis, ALT and AST≤5 ULN；\n\n         * Serum creatinine（SCr）≤1.5 ULN or Creatinine clearance rate(CCr)≥60ml\u002Fmin；\n  3. Doppler ultrasound evaluation：Left ventricular ejection fraction (LVEF) ≥ Low limit of normal (50%)。\n* Thyroid Stimulating Hormone（TSH）or Free Thyroxine（FT4）or Free triiodothyronine（FT3）all within the normal range of ± 10%.\n* Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study period and within 6 months after the end of the study; Serum or urine pregnancy test negative within 7 days prior to enrollment in the study, and must be non lactating.\n* patient; Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.\n\nExclusion criteria: Patients with any of the following conditions will not be included in this study\n\n* Patients who have previously used sildenafil or other histone deacetylase inhibitors;\n* Previously received treatment with immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.);\n* Other malignant tumors that have occurred or are currently present within the past 5 years, except for cured cervical carcinoma in situ, non melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\\];\n* Received systemic anti-tumor therapy, including chemotherapy, immunotherapy, and biological therapy (such as tumor vaccines, cytokines, or growth factors that control cancer), within 28 days before starting the research treatment;\n* Have received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 7 days before starting the research treatment;\n* Planned systemic anti-tumor therapy within 4 weeks prior to enrollment or during the study medication period, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use of mitomycin C within 6 weeks prior to receiving experimental drug treatment). Expanded field radiation therapy (EF-RT) was performed within 4 weeks prior to enrollment, or limited field radiation therapy was performed within 2 weeks prior to grouping to assess tumor lesions;\n* Accompanied by pleural effusion or ascites, causing respiratory syndrome (≥ CTC AE grade 2 respiratory distress \\[grade 2 respiratory distress refers to shortness of breath during light activity; affects instrumental daily activities\\]);\n* Unrelieved toxic reactions above CTC AE (4.01) grade 1 caused by any previous treatment, excluding hair loss;\n* Patients with brain metastases accompanied by symptoms or symptom control time less than 2 months;\n* Patients with any severe and\u002For uncontrolled illnesses, including:\n\n  1. Patients with poor blood pressure control (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);\n  2. Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTC ≥ 480ms), and grade ≥ 2 congestive heart failure (NYHA classification);\n  3. Active or uncontrolled severe infections (≥ CTC AE level 2 infection);\n  4. Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy;\n  5. Renal failure requires hemodialysis or peritoneal dialysis;\n  6. Individuals with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n  7. Poor control of diabetes (FBG\\>10mmol\u002FL);\n  8. Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\\>1.0 g;\n  9. Patients with epileptic seizures who require treatment;\n* Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to enrollment;\n* Patients with any signs or medical history of bleeding, regardless of the severity; Patients who have experienced any bleeding or bleeding events ≥ CTCAE grade 3 within the first 4 weeks of enrollment, with unhealed wounds, ulcers, or fractures;\n* Individuals who have experienced arterial\u002Fvenous thrombotic events within the past 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism;\n* Patients with active ulcers, intestinal perforation, and intestinal obstruction;\n* Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;\n* Participated in clinical trials of other anti-tumor drugs within 28 days prior to enrollment;\n* According to the researchers' judgment, there are accompanying diseases that seriously endanger patient safety or affect the completion of the study.","75 Years",{"count":121,"type":20},30,[23],"Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above.",[63,62,35],"2024-10-10",{"date":127,"type":40},"2024-10-15",{"date":129,"type":40},"2024-08-01",{"date":131,"type":20},"2024-12-31",{"name":133,"class":47},"Shanxi Province Cancer Hospital",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":48},"100521830","phase-2-parp-inhibition-stereotactic-body-radiotherapy-and-immunotherapy-for-metastatic-or-advanced-sarcoma-prima-100521830","NCT06074692","PARP Inhibition, Stereotactic Body Radiotherapy and Immunotherapy for Metastatic or Advanced Sarcoma (PRIMA)","A Prospective Phase II Study of PARP Inhibition and Check Point-inhibition Immunotherapy With Concurrent Stereotactic Body Radiotherapy (SBRT) in Patients With Metastatic or Advanced Sarcoma","PRIMA","Inclusion Criteria:\n\n1. Written informed consent signed before any trial-related procedures are carried out\n2. Histologically confirmed high-grade sarcoma of bone or soft tissue; the lesion has distant metastasis or is locally advanced and cannot be completely resected at the time of enrollment, or the patient cannot tolerate or refuses surgical resection;\n3. Have received at least one systemic treatment regimen(s) at the time of enrollment, and have not received prior PARP inhibitor treatment.\n4. With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST1.1);\n5. Aged no less than 10 years old and no more than 70 years old;\n6. For patients ≥16 years old, ECOG score is between 0 and 2 (for patients with amputations, if they can basically take care of themselves and can move freely for more than 50% of their waking hours with the assistance of stretchers, walkers, wheelchairs, etc.) still included);\n7. For patients under 16 years old, Lansky score is at least 70 or above (for patients with amputations who are unable to participate in active recreational activities due to amputation), if they can participate in most active recreational activities with the assistance of walkers, wheelchairs, etc., they are still eligible included).\n8. The expected survival time is greater than 24 weeks;\n9. The majority of the recurrent lesions with an established radiological diagnosis could receive SBRT;\n10. Major organ functions meet basic safety standards within 7-14 days before treatment.\n11. Women of childbearing age should agree that they must use contraceptive measures (such as intrauterine devices, birth control pills or condoms) during the study and within 6 months after the end of the study; if in doubt, serum or urine tests within 7 days before study enrollment The pregnancy test is negative and the patient must be non-lactating; the male should agree that contraceptive measures must be used during the study period and within 6 months after the end of the study period;\n12. If there are recurrent lesions previously treated by surgery, radiofrequency ablation or radiotherapy:\n\n    1. If the image of the metastatic lesion is stable, enrollment is allowed and SBRT is not required for that lesion;\n    2. If the metastatic lesion has image progression, if it was previously treated with surgery and SBRT can be performed, enrollment is allowed; if it was previously treated with radiofrequency ablation or radiotherapy, if repeat SBRT can be considered, enrollment is allowed.\n\nExclusion Criteria:\n\n1. Diagnosed with malignant diseases other than tumors within 5 years before the first dose;\n2. Currently participating in interventional clinical research treatment, or have received other research drugs or used research equipment within 4 weeks before the first dose;\n3. Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs targeting another stimulating or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137) drug and secondary resistance to the drug (i.e., the best efficacy evaluation is CR, PR or SD lasting more than 4 months, but secondary tumor resistance develops after treatment).\n4. Received systemic systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except local use to control pleural effusion) within 2 weeks before the first dose;\n5. Active autoimmune disease requiring systemic treatment (such as use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;\n6. Are receiving systemic glucocorticoid treatment (excluding nasal spray, inhaled or other route of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study;\n7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n8. Known to be allergic to any components of monoclonal antibody preparations (have experienced grade 3 or above allergic reactions);\n9. Have not fully recovered from toxicity and\u002For complications caused by any intervention before initiating treatment (i.e., ≤Grade 1 or reaching baseline, excluding fatigue or alopecia);\n10. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV1\u002F2 antibody positive);\n11. Get live vaccine within 30 days before the first dose (cycle 1, day 1);\n12. Pregnant or lactating women;\n13. Any serious or uncontrollable systemic disease","70 Years",{"count":144,"type":20},86,[23],"The aim of this study is to evaluate the efficacy and safety of PARP Inhibition and programmed cell death protein-1 (PD-1) blockade immunotherapy with concurrent stereotactic body radiotherapy (SBRT) for metastatic or advanced bone and soft tissue sarcoma.",[62,63,35],[149,150,151,152,153],"sarcoma","bone and soft tissue sarcoma","PARP inhibitor","SBRT","checkpoint inhibitor","2023-10-29",{"date":156,"type":40},"2023-10-31",{"date":158,"type":40},"2023-06-01",{"date":160,"type":20},"2026-12-30",{"name":162,"class":47},"Ruijin Hospital"]