[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sarcoma-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sarcoma-metastatic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,77,106,135,159],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100641743","early-phase-1-pilot-study-of-tumorglow-for-intraoperative-molecular-imaging-of-sarcoma-metastases-to-the-lungs-in-pediatric-patients-100641743",false,"NCT07658768","Pilot Study of TumorGlow for Intraoperative Molecular Imaging of Sarcoma Metastases to the Lungs in Pediatric Patients","TumorGlow","Inclusion Criteria:\n\n* 1\\. Male and female children (12 - 17 years of age) with a primary diagnosis, or a high clinical suspicion of a solid tumor with metastasis to the lung warranting surgery based on CT\u002FPET or other imaging 2. Are scheduled to undergo surgical resection for suspected metastasis 3. Female subjects of childbearing potential (including those less than 2 years postmenopausal) agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after infusion of ICG. Male subjects who are are sexually active (and capable of producing sperm) with a partner that could become pregnant, must agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after infusion of ICG.\n\nExclusion Criteria:\n\n* 1\\. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject 2. History of anaphylactic reactions to ICG. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation 3. A positive serum pregnancy test at screening for female subjects of childbearing potential. Note that subjects with a positive pregnancy test on the day of infusion will be discontinued from study and will not receive the study drug.\n\n  4\\. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule 5. Impaired liver function defined as values \\> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT),aspartate aminotransferase (AST), or alkaline phosphatase (ALP), or \\>2x ULN for total bilirubin except in subjects with Gilbert's syndrome. \\*For subjects with Gilbert's syndrome, total bilirubin levels exceeding 3 mg\u002FdL will be excluded.\\* 6. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug 7. History of uncontrolled hypertension. (e.g., history of an emergency room \\[ER\\] admission for hypertensive crisis or ≥ 3 BP medications) 8. Known sensitivity to fluorescent light","ALL","12 Years","17 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","Subjects will undergo infusion of 5 mg\u002Fkg indocyanine green, ICG (\"TumorGlow\") intravenously up to 5-days prior to surgery. Then, during the surgical procedure the next day, the subjects will undergo standard-of-care surgery. During the surgery, the fluorescence from the tumor will be used to localize lesions and ensure the entire tumor has been removed, as well as locate any un-expected tumors. The goal of this protocol is to evaluate safety and collect initial efficacy data using indocyanine green with NIR fluorescence imaging in a pediatric patient population undergoing pulmonary metastatectomy.",[27],"Sarcoma Metastatic",[29,30],"metastasis","sarcoma","NOT_YET_RECRUITING","2026-06-17",{"date":34,"type":35},"2026-06-22","ACTUAL",{"date":37,"type":21},"2026-09-01",{"date":39,"type":21},"2027-05-01",{"name":41,"class":42},"Abramson Cancer Center at Penn Medicine","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100560022","phase-2-xl092-zanzalintinib-for-the-treatment-of-patients-with-metastatic-or-unresectable-leiomyosarcoma-bone-sarcoma-or-translocation-associated-soft-tissue-sarcoma-100560022","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","18 Years",{"count":52,"type":21},73,[54],"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).",[57,58,59,60,61,62,63,64,27,65],"Metastatic Leiomyosarcoma","Unresectable Leiomyosarcoma","Bone Sarcoma","Translocation-associated Soft Tissue Sarcoma","Synovial Sarcomas","Osteosarcoma Metastatic","Ewing Sarcoma","Ewing Sarcoma Metastatic","Sarcoma of Bone","RECRUITING","2026-06-16",{"date":69,"type":35},"2026-06-18",{"date":71,"type":35},"2024-09-19",{"date":73,"type":21},"2033-07-01",{"name":75,"class":42},"Northwestern University",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":76},"100630625","benefits-of-early-collaboration-between-oncologists-and-palliative-care-physicians-in-cases-of-unplanned-hospitalization-for-patients-with-metastatic-cancer-100630625","NCT07490106","Benefits of Early Collaboration Between Oncologists and Palliative Care Physicians in Cases of Unplanned Hospitalization for Patients With Metastatic Cancer","SPPC","Inclusion Criteria:\n\n* Subjects aged 18 years and older;\n* Diagnosed with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer;\n* Currently undergoing systemic palliative treatment (no prospect of cure);\n* Hospitalized on an unscheduled basis (i.e., unplanned hospitalization for scheduled oncology treatments);\n* Patient covered by the French social security system;\n* Informed consent, written and signed.\n\nExclusion Criteria:\n\n* PS (WHO) = 4;\n* Patient receiving end-of-life care;\n* Patient opposed to the use of medical data for research purposes;\n* Person deprived of liberty or under guardianship;\n* Inability to undergo medical monitoring for the trial for geographical, social, or psychological reasons.",{"count":85,"type":21},493,[87],"NA","This is a multicenter, national, interventional, cluster-randomized study, \"stepped wedge\" design. This study includes patients with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer, currently undergoing systemic palliative treatment and hospitalized on an unscheduled basis. The study will aim to evaluate the impact of early palliative care implementation for patients with metastatic or advanced cancer identified during an unplanned hospitalization.",[90,27,91,92,93,94],"Cancer","Gynaecologic Cancer","Digestive Cancers","ENT Cancer","Metastatic Cancer or Locally Advanced",[96],"Metastatic or Locally Advanced digestive, gynecological, ENT, or sarcoma cancer","2026-03-19",{"date":99,"type":35},"2026-03-24",{"date":101,"type":21},"2026-04",{"date":103,"type":21},"2031-04",{"name":105,"class":42},"Centre Oscar Lambret",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100532319","superiority-trial-evaluating-digitalized-information-media-for-patients-with-advanced-sarcomas-receiving-systemic-treatment-100532319","NCT06211257","Superiority Trial Evaluating Digitalized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment.","Phase 3 Superiority Trial Evaluating the Benefit of Dematerialized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment for Metastatic or Locally Advanced Disease.","ePPS","Inclusion Criteria:\n\n* Sarcomas of soft tissues or viscera ;\n* Inoperable metastatic or locally advanced disease ;\n* Indication for systemic treatment with pazopanib, trabectedine, eribulin, ifosfamide or dacarbazine monotherapy ;\n* Patient covered by French social security ;\n* Written, signed, informed consent ;\n\nExclusion Criteria:\n\n* Prior inclusion in ePPS trial for a prior systemic treatment ;\n* Poor understanding of French ;\n* Difficulty accessing a computer ;\n* Pregnant or nursing woman ;\n* Person deprived of liberty or under guardianship ;\n* Impossibility of undergoing medical follow-up for geographical, social or psychological reasons.",{"count":115,"type":21},377,[87],"ePPS-2202 is a study designed to evaluate the benefits of a dematerialised personalised care plan (PCP) compared to standard information\u002FPCP for patients with advanced sarcomas receiving systemic treatment.\n\nParticipants will be randomised to an experimental group or a control group. Patients in the experimental group will receive the dematerialised PCP in addition to the standard PCP while patients in the control group will receive the standard PCP alone.\n\nAll patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up.",[27,119],"Locally Advanced Soft Tissue Sarcoma",[121,122,123,124,125],"Sarcoma","Advanced","Dematerialised","Care","Plan","2026-03-16",{"date":128,"type":35},"2026-03-18",{"date":130,"type":35},"2024-05-29",{"date":132,"type":21},"2030-04",{"name":105,"class":42},11,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100615337","phase-2-metformin-hydrochloride-in-combination-with-standard-of-care-systemic-therapy-in-previously-untreated-advanced-unresectable-or-metastatic-soft-tissue-sarcoma-100615337","NCT07291297","Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Advanced unresectable or metastatic\u002Fintermediate\u002Fhigh grade soft tissue sarcoma\n2. Age ≥ 18 years at the time of enrollment\n3. Initiating first line systemic therapy for advanced\u002Fmetastatic disease (treatment naïve for advanced\u002Fmetastatic disease)\n\n   1. Participants who have not yet initiated first line systemic therapy: expected to initiate front-line therapy within 4 weeks of initiating metformin\n   2. Participants who have previously initiated first line systemic therapy: No more than 4 weeks from initiation of first line systemic therapy\n4. Adequate performance status (PS) defined as ECOG PS = 0-2\n5. Adequate renal function\n6. Adequate liver function\n7. Individuals of childbearing potential (ICBP) must have a negative serum pregnancy test within 7 days prior to enrollment. NOTE: Individuals who may become pregnant are considered to have childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause). Metformin is known to be excreted in breast milk and should not be used by nursing mothers.\n8. ICBP and partners of ICBP must not be expecting to conceive and be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of \\\u003C1% per year when used consistently and correctly) from the time of informed consent until 30 days after study treatment discontinuation.\n9. Individuals who are having sexual relationships in which their partners may become pregnant must be willing to use condoms from the time of informed consent until 30 days after study treatment discontinuation. For a non-pregnant ICBP partner, contraception recommendations should also be considered.\n10. Ability to ingest oral medications\n\nExclusion Criteria:\n\n1. Already prescribed and taking metformin at time of diagnosis of advanced unresectable or metastatic disease\n2. Planned enrollment on a treatment clinical trial for first line therapy\n3. Breastfeeding within the duration of anticipated study treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.\n4. History of acute or chronic metabolic acidosis including diabetic ketoacidosis, with or without coma.\n5. Participants previously diagnosed with an additional malignancy must be disease-free for at least five years prior to enrollment. Exceptions include ductal carcinoma in situ (DCIS), basal cell or squamous cell skin cancer and in situ cervical or bladder cancer.\n6. Treatment with any investigational drug within 14 days prior to day 1 of treatment\n7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin. Participants receiving any medications or substances that are inhibitors or inducers of CYP450 enzyme(s) are ineligible. Lists including medications and substances known or with the potential to interact with the specified CYP450 enzyme(s) isoenzymes. Please refer to https:\u002F\u002Fdrug-interactions.medicine.iu.edu\u002FMainTable.aspx for the most current information.\n8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure requiring pharmacologic treatment, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements as determined by the investigator.\n9. Patients with known brain or active central nervous system (CNS) metastases.",{"count":142,"type":21},50,[54],"The purpose of this research study is to see how metformin, when used in combination with standard of care (SOC) treatment for metastatic (cancer that has spread) soft tissue sarcoma can improve patient outcomes.",[27,146],"Sarcoma, Soft Tissue",[148,149],"Advanced Unresectable or Metastatic Soft Tissue Sarcoma","Metformin Hydrochloride","2026-03-04",{"date":152,"type":35},"2026-03-05",{"date":150,"type":35},{"date":155,"type":21},"2033-10",{"name":157,"class":42},"Wake Forest University Health Sciences",2,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":173,"conditions":174,"keywords":181,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":76},"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":170,"type":21},60,[172,54],"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.",[121,175,176,177,178,179,27,180,65],"Sarcoma, Kaposi","Sarcoma, Ewing","Sarcoma,Soft Tissue","Sarcoma of Bone and Connective Tissue","Sarcoma, Synovial","Sarcomas, Germinoblastic",[121,182,183,184,65],"CD146","HER2","CAR-T","2025-07-04",{"date":187,"type":35},"2025-07-15",{"date":189,"type":35},"2025-05-29",{"date":191,"type":21},"2028-12-28",{"name":193,"class":42},"Essen Biotech"]