[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alveolar-soft-part-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alveolar-soft-part-sarcoma":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,59,83,116,139,166,196,226],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":42,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100564132","phase-1-alphabeta-t-and-b-cell-depletion-with-zoledronic-acid-for-solid-tumors-100564132",false,"NCT06625190","Alpha\u002FBeta T and B Cell Depletion With Zoledronic Acid for Solid Tumors","Allogeneic Stem Cell Transplantation Utilizing Alpha\u002FBeta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed\u002FRefractory Solid Tumors","Inclusion Criteria:\n\n* Patients 6 months to ≤ 25 years old\n* Relapsed\u002FRefractory Solid Tumor whom failed or deemed ineligible to receive autologous transplant or if autologous transplant did not offer \\>20% chance of cure with the following diseases:\n\n  1. neuroblastoma (high risk with relapsed or refractory disease),\n  2. relapsed\u002Frefractory rhabdomyosarcoma,\n  3. relapsed\u002Frefractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),\n  4. High risk adult type NRSTS: clear cell sarcoma, alveolar soft part sarcoma,\n  5. Other high-risk extracranial solid tumors: desmoplastic small round cell tumors, chordoma, malignant rhabdoid tumor, epithelioid sarcoma, myoepithelial tumor\n  6. relapsed\u002Frefractory bone tumors: osteosarcoma and Ewing sarcoma\u002FPNET, or\n  7. Wilm's tumor or other high-risk solid tumors with \\\u003C10% expected survival with conventional treatment.\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* Haplo-identical related donor (at least one full haplotype must be matched).\n* Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients \\>16 years of age and Lansky scores for patients ≤16 years of age\n* Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:\n\n  1. Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.\n  2. Renal: Creatinine clearance or radioisotope GFR ≥60 mL\u002Fmin\u002F1.73 m2 or a serum creatinine based on age\u002Fgender\n  3. Cardiac: Ejection fraction of ≥ 40% by echocardiogram or radionuclide scan (MUGA).\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Individuals of childbearing potential (IOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for one year following transplantation to minimize the risk of pregnancy. Prior to study enrollment, individuals of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factor for an unintentional pregnancy.\n* Subjects with female 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 one year following stem cell transplantation.\n\nExclusion Criteria:\n\n* Patients with documented uncontrolled infection at the time of study entry are not eligible.\n\n  a. Uncontrolled infection is patient without treatment antimicrobials and\u002For demonstrating progression despite antimicrobials\n* Patients with progressive solid tumor disease after relapsed\u002Frefractory treatment.\n* Demonstrated lack of compliance with medical care, as determined by the treating physician.\n* Patients who have received an allogeneic HSCT within 6 months.\n* Patients who do not have an eligible allogeneic donor available.\n* Patients with a life expectancy \\\u003C3 months\n* Patients not meeting inclusion criteria for organ function.\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 one year after transplantation.\n* Females who are known to be pregnant or breastfeeding.\n* History of any other disease, metabolic dysfunction, clinical 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* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","ALL","6 Months","25 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur.\n\nWhile solid tumors can be highly chemotherapy sensitive, many remain resistant and require multimodalities of treatment. Immunotherapy has been developed to harness the immune system in fighting solid tumors, though not all have targeted effects. Some solid tumors are treated with autologous transplants; however, they do not always demonstrate an improved event free survival or overall survival. There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect, though studies remain limited.\n\nBy utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid, the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsed\u002Frefractory solid tumors and promote an improved event-free survival and overall survival.\n\nThis study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors, as well as whether this treatment improves survival rates in these patients.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Neuroblastoma","Rhabdomyosarcoma","Synovial Sarcoma","Peripheral Nerve Sheath Tumors","Clear Cell Sarcoma","Alveolar Soft Part Sarcoma","Desmoplastic Small Round Cell Tumor","Chordoma","Rhabdoid Tumor","Epithelioid Sarcoma","Myoepithelial Tumor","Osteosarcoma","Ewing Sarcoma","Wilms Tumor",[43,44,45],"pediatric solid tumors","stem cell transplantation","graft manipulation","RECRUITING","2026-06-25",{"date":49,"type":50},"2026-06-30","ACTUAL",{"date":52,"type":50},"2026-02-11",{"date":54,"type":21},"2030-02",{"name":56,"class":57},"University of Florida","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":78,"leadSponsor":80,"locationsCount":58},"100615827","phase-1-gcar1-a-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsedrefractory-gpnmb-expressing-solid-tumours-100615827","NCT07297667","GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed\u002FRefractory GPNMB-Expressing Solid Tumours","A Phase I Study of GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Participants With Selected Relapsed\u002FRefractory GPNMB-Expressing Solid Tumours","Inclusion Criteria:\n\n* Archival tumour specimen must be positive for GPNMB with high expression by immunohistochemistry (central laboratory testing).\n* Histologically and\u002For cytologically confirmed diagnosis of one of the following tumours that is advanced\u002F metastatic\u002F recurrent or unresectable, for which no curative therapy exists.\n* alveolar soft part sarcoma\n* renal cell carcinoma (excluding clear cell)\n* triple negative breast cancer (ER, PR and HER-2 negative as defined by ASCO\u002FCAP criteria)\n* Must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block.\n* Presence of radiologically documented disease.\n* Measurable disease as defined by RECIST 1.1.\n* ASPS participants ≥ 15 years of age.\n* TNBC and RCC participants ≥ 18 years of age.\n* ECOG performance status of 0 or 1 or Karnofsky or Lansky \\> 60.\n* Anticipated life expectancy of ≥ 6 months.\n* Must have received prior systemic therapy as shown below;\n* ASPS - completed all systemic therapy available that has been shown to improve survival (unless contraindicated).\n* TNBC\n\n  1. Progressive disease following at least one line of systemic treatment for metastatic disease which must include an ADC (all participants) and an ICI (participants whose tumours express PD-L1).\n  2. ≤3 lines of treatment for metastatic disease.\n  3. Must have had at least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, which must have included an anthracycline and a taxane (unless contraindicated).\n* RCC - must have progressive disease following at least one line of systemic treatment for metastatic disease that must have included an ICI and a VEGFR targeted agent (unless contraindicated).\n* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.\n* Adequate washout must be followed per protocol.\n* Previous major surgery is permitted ≥21 days prior to enrollment\n* Prior external beam radiation is permitted ≥28 prior to enrollment. Concurrent radiotherapy is not permitted.\n* Adequate hematologic and biochemical parameters.\n* Consent and assent, when applicable, must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant or their parent\u002F legal guardian (if applicable) must sign a consent form prior to screening onto the trial to document their willingness to participate.\n* Fit for leukapheresis and has adequate venous access for cell collection.\n* Must be accessible for treatment and follow up at the participating centre for a minimum of 12 months or for as long as is deemed necessary by the treating physician.\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion criteria\n\n* Participants on active anticancer therapy for other advanced or metastatic malignancies.\n* Concurrent treatment with other anti-cancer therapy\n* Prior therapy with a gene therapy product or any adoptive T cell therapy or prior GPNMB targeting therapy.\n* Live attenuated vaccination administered within 30 days prior to or planned within 30 days after GCAR1 therapy.\n* Primary immunodeficiency or history of severe autoimmune disease (including: Crohn's disease, rheumatoid arthritis, systemic lupus) requiring immunosuppressive agents\u002F systemic disease modifying agents within 2 years of enrollment.\n* Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol including but not limited to:\n* Hepatitis B or C virus (HBV or HCV). For participants with previous HBV or HCV infection who are currently on treatment, they are eligible if they have an undetectable viral load via quantitative PCR and\u002For nucleic acid testing\n* HIV positive by serology and PCR\n* Uncontrolled fungal, bacterial, viral or other infection\n* Current infection with HTLV-1\n* Tuberculosis\n* Syphilis\n* West Nile Virus\n* Untreated and\u002For uncontrolled cardiovascular conditions and\u002For symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or unstable angina congestive heart failure or myocardial infarction within the previous year.\n* Known sensitivity or allergy to fludarabine, cyclophosphamide or any of their components, or to GCAR1 or any of its components.\n* Active intracerebral metastases or leptomeningeal disease. Participants who have received definitive treatment, are clinically stable and do not require corticosteroids are eligible to participate in the trial.\n* Pregnant or breastfeeding women.","15 Years",{"count":68,"type":21},30,[24],"Only enrolling in Canada.\n\nThe purpose of this study is to identify the highest dose of GCAR1, a chimeric antigen receptor (CAR-T) cell therapy, that can be tolerated without causing very severe side effects, and to see what effects GCAR1 has on selected cancers",[33,72,73],"Renal Cell Carcinoma","Triple Negative Breast Cancer","2026-06-04",{"date":76,"type":50},"2026-06-08",{"date":49,"type":21},{"date":79,"type":21},"2033-09-01",{"name":81,"class":82},"Canadian Cancer Trials Group","NETWORK",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100388061","phase-2-a-study-of-pembrolizumab-plus-local-chemotherapy-using-isolated-limb-infusion-ili-for-patients-with-sarcoma-in-the-arm-or-leg-100388061","NCT04332874","A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg","A Phase II Study of Concurrent Systemic Pembrolizumab and Isolated Limb Infusion (ILI) With Melphalan and Dactinomycin for Patients With Locally Advanced or Metastatic Extremity Sarcoma","Inclusion Criteria:\n\nPatients must fulfill all of the following criteria to be eligible for admission to the study. Any exceptions from the protocol-specific selection criteria must be approved by the Principal Investigator and\u002For the Institutional Review Board (IRB) before enrollment.\n\n* Age \\>\u002F= 12 years at the time of informed consent\n* Willing and able to provide written informed consent\u002Fassent for the trial\n* Willing to comply with treatment protocol\n* Have a histologically confirmed metastatic and\u002For locally advanced sarcoma\n* Eligible for standard treatment with pembrolizumab\n* Eligible for an isolated limb infusion (ILI) as determined by the treating physician\n* Have undergone at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) or have declined the standard of care systemic option.\n* Have measurable disease (at least one index lesion) as defined by RECIST 1.1 or by clinical measurement for superficial lesions not amenable to radiographic surveillance. Index 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* Adequate performance status: ECOG \\\u003C\u002F= 2 or KPS \\>\u002F= 60%\n* Adequate organ function determined within 3 weeks of treatment initiation, defined as follows:\n\n  * Hemoglobin \\>\u002F= 8.0 g\u002FdL\n  * Absolute neutrophil count \\>\u002F= 1,000\u002Fmm\\^3 (1.0 x 10\\^9\u002FL)\n  * Platelet count \\>\u002F= 50,000\u002Fmm\\^3 (50 x 10\\^9\u002FL)\n  * Serum bilirubin \\\u003C\u002F= 1.5 x upper limit of normal (ULN) OR direct bilirubin \\\u003C\u002F= ° ° ULN for a patient with total bilirubin level \\> 1.5 x ULN Aspartate aminotransferase (AST) \\\u003C\u002F= 2.5 x ULN OR \\\u003C\u002F= 5 x ULN for patients with liver metastases\n  * Alanine aminotransferase (ALT) \\\u003C\u002F= 2.5 x ULN OR \\\u003C\u002F= 5 x ULN for patients with liver metastases\n  * Alkaline phosphatase \\\u003C 5 x ULN\n  * Serum creatinine \\\u003C\u002F= 1.5 x ULN or a measured or calculated creatinine clearance \\>\u002F= 60 mL\u002Fmin for a patient with creatinine levels \\> 1.5 x institutional ULN (Note: Creatinine clearance need not be determined if the baseline serum creatinine is within normal limits. GFR can also be used in place of creatinine or CrCl)\n  * International normalized ratio (INR) or prothrombin time (PT) \\\u003C\u002F= 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n  * Activated partial thromboplastin time (aPTT) \\\u003C\u002F= 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT is within therapeutic range of intended use of anticoagulants\n\nCreatinine clearance should be calculated per institutional standard.\n\nFor female patients of childbearing potential, negative serum pregnancy test at screening visit and within 72 h prior to the first dose of study medication.\n\nExclusion Criteria:\n\nPatients who fulfil any of the following criteria are not eligible for admission to the study:\n\n* Have any other malignancy that requires active treatment\n* Ineligible for ILI because of underlying physical conditions (e.g. coronary artery disease with inability to tolerate anesthesia) as determined by treating physician\n* Has previously experienced hypersensitivity to pembrolizumab or any of its excipients\n* Has uncontrolled intercurrent illness including active infection requiring systemic therapy or symptomatic congestive heart failure within the past 6 months\n* Has known active central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to study Day 1 and return to baseline of neurologic symptoms), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include sarcomatous meningitis, which is excluded regardless of clinical stability.\n* Shows 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 7 days prior to enrollment. However, in the setting of non-immune mediated indications for use, chronic\u002Factive low dose steroid use may be permitted at the discretion of the principal investigator.\n* Has a known active or chronic infection with HIV if CD4 count is less than 500.\n* Has a known active infection with hepatitis B or hepatitis C\n* Has a known history of active tuberculosis infection\n* Has history or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in the past 2 years. 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* For female subjects, is pregnant or breast-feeding, or planning to become pregnant\n* For male subjects, is planning to father a child within the projected duration of the trial, starting with the pre-screening or screening visit, during study treatment and through 4 months after the last dose of pembrolizumab\n* For patients of childbearing potential, is unwilling to use acceptable method(s) of effective contraception during study treatment and through 4 months after the last dose of pembrolizumab.\n\n(Women not of childbearing potential are defined as: post-menopausal \\[age \\> 55 years with cessation of menses for 12 or more months or less than 55 years but not spontaneous menses for at least 2 years or less than 55 years and spontaneous menses within the past 1 year, but currently amenorrhoeic (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels \\> 40 IU\u002FL) or postmenopausal estradiol levels (\\\u003C 5 ng\u002FdL) or according to the definition of \"postmenopausal range\" for the laboratory involved\\] or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.)\n\n* Underwent prior chemotherapy, radiotherapy, biological cancer therapy, targeted small molecule therapy, or major surgery within 14 days prior to study Day 1 or has not recovered (i.e., to CTCAE \\\u003C\u002F= grade 1 or at baseline) from adverse events due to previously administered therapy. Patients with \\\u003C\u002F= grade 2 neuropathy and alopecia are an exception and may qualify for the study. If patients received major surgery, they must have recovered adequately prior to starting therapy.\n* Is currently participating and receiving study therapy with another investigational device or study drug or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial","12 Years",{"count":68,"type":21},[25],"The purpose of this study is to find out whether giving the study drug pembrolizumab in combination with the chemotherapy drugs melphalan and dactinomycin, delivered directly to the affected arm or leg using a technique called isolated limb infusion (ILI), is a safe treatment that can delay the time before your disease gets worse (progresses).",[95,96,97,33],"Sarcoma","Myxofibrosarcoma","Undifferentiated Pleomorphic Sarcoma",[95,96,97,33,99,100,101,102,103,104,105,106],"Pembrolizumab","Isolate Limb Infusion","Melphalan","Dactinomycin","Metastatic Extremity Sarcoma","Locally Advanced Sarcoma","20-104","Memorial Sloan Kettering Cancer Center","2026-04-22",{"date":109,"type":50},"2026-04-23",{"date":111,"type":50},"2020-04-01",{"date":113,"type":21},"2027-04-01",{"name":106,"class":57},7,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":138},"100635091","phase-2-clinical-trials-of-benmelstobart-injection-combined-with-anlotinib-hydrochloride-capsules-in-the-treatment-of-advanced-or-unresectable-alveolar-soft-part-sarcoma-100635091","NCT07548177","Clinical Trials of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma","To Evaluate the Single-arm, Multi-center Phase II Clinical Trial of Benmelstobart Injection Combined With Anlotinib Hydrochloride Capsules in the Treatment of Advanced or Unresectable Alveolar Soft Part Sarcoma","Inclusion Criteria:\n\n* Only when all the following criteria are met will the subjects be eligible for inclusion in this study:\n\n  1. The subjects voluntarily join this study, sign the informed consent form, and have good compliance;\n  2. ≥14 years old (calculated from the date of signing the informed consent form);\n  3. Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 1;\n  4. Expected survival greater than 12 weeks;\n  5. Pathologically confirmed recurrent and\u002For metastatic or unresectable alveolar soft part sarcoma, without previous systemic treatment;\n  6. Confirmed to have at least one measurable lesion according to RECIST 1.1;\n  7. Laboratory tests meet the following standards:\n\n     1. Hemoglobin (HGB) ≥ 90g\u002FL;\n     2. Absolute neutrophil count (NEUT) ≥ 1.5×109\u002FL;\n     3. Platelet count (PLT) ≥ 100×109\u002FL.\n     4. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);\n     5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN. If there is liver metastasis, ALT and AST ≤ 5 ULN;\n     6. Serum creatinine (CR) ≤ 1.5 ULN or creatinine clearance rate (CCR) ≥ 60ml\u002Fmin;\n     7. Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN (if not receiving anticoagulant therapy);\n     8. Thyroid stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be examined. If T3 and T4 levels are normal, the subject can be included.\n  8. Women of childbearing age must agree to use effective contraceptive measures during the study and for 6 months after the study, and have a negative serum test within 7 days before study enrollment; men must agree to use effective contraceptive measures during the study and for 6 months after the study.\n\nExclusion Criteria:\n\n* Any subject meeting any of the following criteria will be excluded from this trial:\n\n  1. Having had or currently having another malignant tumor within 5 years before the first administration of the drug. The following two situations are eligible for inclusion: other malignant tumors treated with a single surgery and achieving a disease-free survival (DFS) of at least 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\\].\n  2. Having diseases that affect intravenous injection or blood collection, or having multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc.).\n  3. Adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade score of ≤1, except for grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, and stable hypothyroidism treated with hormone replacement therapy, which are judged by the investigator to have no safety risks.\n  4. Having undergone major surgery, significant traumatic injury, or expected to undergo major surgery during the study period within 4 weeks before the first administration of the drug (except for surgeries specified in the protocol), or having long-term unhealed wounds or fractures. (Major surgery is defined as: surgeries classified as grade 3 or above in the 2023 version of the surgical classification directory of the participating center).\n  5. Having experienced any bleeding or hemorrhagic event ≥ CTCAE grade 3 within 4 weeks before the first administration of the drug.\n  6. Having experienced an arterial or venous thrombotic event within 6 months before the first administration of the drug, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.\n  7. Active viral hepatitis that is not well controlled. Subjects meeting the following requirements can be screened: HBsAg-positive subjects must have Hepatitis B Virus (HBV) DNA quantification \\\u003C 2000 IU\u002Fml (or 1\\*104 copies\u002Fml) or have received at least 1 week of antiviral treatment for HBV before the start of the study and have a 10-fold (1 log value) or greater reduction in viral index, and be willing to receive antiviral treatment throughout the study; HCV-infected subjects (HCV Ab or HCV RNA positive): judged by the investigator to be in a stable state or receiving antiviral treatment at the time of enrollment and continuing to receive approved antiviral treatment during the study.\n  8. Active syphilis infection requiring treatment.\n  9. Having active tuberculosis, a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or active pneumonia with clinical symptoms.\n  10. Having a history of substance abuse of psychotropic drugs and being unable to quit or having a mental disorder.\n  11. Preparing for or having previously received allogeneic bone marrow transplantation or solid organ transplantation.\n  12. Having major cardiovascular diseases, including any of the following conditions:\n\n      1. Cardiac insufficiency of New York Heart Association Functional Classification (NYHA) class II or above or echocardiography showing left ventricular ejection fraction (LVEF) \\\u003C 50%;\n      2. History of clinically significant ventricular arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes ventricular tachycardia) or arrhythmias requiring continuous antiarrhythmic drug treatment;\n      3. Unstable angina pectoris;\n      4. Myocardial infarction within 12 months;\n      5. Fridericia-corrected QT interval (QTcF) \\> 450 milliseconds (msec) for men and \\> 470 msec for women (if QTc is abnormal, it can be continuously measured three times with an interval of more than 2 minutes, and the average value is taken);\n      6. History or family history of congenital long QT syndrome. 7) A history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolic event within 3 months prior to randomization (implantable venous access ports or catheter-related thrombosis, or superficial venous thrombosis are not considered \"serious\" thromboembolic events);\n      7. Currently using or having used within 7 days prior to the start of study treatment aspirin (\\>325 mg\u002Fday (maximum antiplatelet dose)), dipyridamole, ticlopidine, clopidogrel, or cilostazol;\n  13. Active or uncontrolled severe infection (≥CTC AE grade 2 infection);\n  14. Renal failure requiring hemodialysis or peritoneal dialysis;\n  15. History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases;\n  16. Subjects who need to use immunosuppressants, systemic or absorbable local hormones for immunosuppression purposes and will continue to do so within 7 days before the first administration (except for glucocorticoids at a daily dose of \\\u003C10 mg prednisone or other equivalent efficacy hormones);\n  17. Patients with epilepsy requiring treatment;\n  18. Tumor-related symptoms and treatment:\n\n      1. Having received treatment with traditional Chinese patent medicines with clear anti-tumor indications in the National Medical Products Administration (NMPA)-approved drug instructions (including Compound Cantharidin Capsules, Kang'ai Injection, Kanglaite Capsules\u002FInjection, Aidi Injection, Brucea javanica Oil Injection\u002FCapsules, Xiaoaiping Tablets\u002FInjection, Chan Su Capsules, etc.) within 2 weeks prior to the start of study treatment;\n      2. Having received previous treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, or Cytotoxic T-Lymphocyte-Associated Antigen 4 (CTLA-4);\n      3. Having previously used anti-angiogenic drugs such as bevacizumab, anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, or fruquintinib;\n      4. Having received treatment with drugs with immunomodulatory functions (such as interleukin-2, thymosin, polysaccharides from Lentinus edodes, etc.) within 30 days prior to the start of treatment;\n      5. Not having recovered from the toxicity and\u002For complications of previous interventions to CTCAE ≤ grade 1, except for alopecia and peripheral neuropathy ≤ grade 2. ；\n      6. Imaging studies (CT or MRI) show that the tumor has invaded major blood vessels or the investigator deems that the tumor is highly likely to invade major blood vessels and cause fatal hemorrhage during the subsequent study period;\n      7. Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites (as judged by the investigator) that requires repeated drainage;\n      8. Known to have spinal cord compression, carcinomatous meningitis, brain metastases with symptoms or symptoms controlled for less than 4 weeks.\n  19. Known to be allergic to the excipients of the study drug.\n  20. Participants who have taken part in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration of the study drug.\n  21. As judged by the investigator, there are serious conditions that endanger the safety of the participant or affect the participant's completion of the study.","14 Years",{"count":125,"type":21},33,[25],"This is a Phase II, single-arm, multicenter clinical study aimed at demonstrating the effectiveness of benmelstobart injection combined with anlotinib hydrochloride capsules in patients aged 14 years or older with advanced or unresectable alveolar soft part sarcoma by evaluating the objective response rate (IRC).",[33],"2026-04-17",{"date":109,"type":50},{"date":132,"type":50},"2026-04-02",{"date":134,"type":21},"2028-11",{"name":136,"class":137},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",15,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":147,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100287066","phase-3-phase-iii-trial-of-anlotinib-catequentinib-in-advanced-alveolar-soft-part-sarcoma-leiomyosarcoma-synovial-sarcoma-apromiss-100287066","NCT03016819","Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)","A Phase III Study of AL3818 (Anlotinib, Catequentinib) Hydrochloride Monotherapy in Subjects With Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma","APROMISS","Inclusion Criteria\n\n1. Written informed consent provided before any study-specific procedures are initiated. Subject must be able to understand and be willing to sign a written informed consent form.\n2. Male or female at least 18 years of age.\n3. a. Indication A - ASPS: Histologically proven, unresectable, locally advanced or metastatic alveolar soft part sarcoma. b. CLOSED Indication B - LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, vascular origin and of the bone). c. CLOSED Indication C - SS: Histologically proven, unresectable, recurrent, locally advanced or metastatic synovial sarcoma. d. CLOSED Indication D - LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, and vascular origin).\n\n3\\. Open Indication E: Any sarcomas or other solid tumors 4. a. Indication A - ASPS: Subjects with or without prior therapy. b. Indications B - LMS: Subjects previously treated with at least one prior line of approved therapy. (New Recruitment Suspended) c. Indication C - SS: Subjects previously treated with at least one prior line of standard systemic therapy, including first-line anthracycline containing regimen (except if medically contraindicated or refused by subject). d. Indication D - LMS: Treatment of patients with metastatic or advanced leiomyosarcoma (LMS) who have failed at least one prior line of standard therapy and are ineligible for or refuse standard second-line therapy or are suitable for third- and further-line treatment. Patients must have received and progressed on prior therapy and have been treated any line with an anthracycline. e. Indication E: Any sarcomas or other solid tumors such as NSCLC, SCLC and Thyroid cancer etc.: Subjects exhausted SOC treatment or refuse for any SOC treatment.\n\n5\\. Show clinical or objective disease progression after the last administration of the last standard therapy or have stopped standard therapy due to intolerability within 6 months of enrollment (excluding ASPS subjects who have not received prior therapy).\n\n6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 confirmed by CT or MRI scan of the chest, abdomen and pelvis (and other areas of disease) within 28 days prior to enrollment. 8. Life expectancy of at least 3 months.\n\n9\\. Females of childbearing potential must have a negative pregnancy test (by serum beta- HCG) within 7 days prior to the start of treatment.\n\n10\\. Female of childbearing potential must be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation), abstinent (at the discretion of the investigator), or agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 2 years. Males must agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) at the discretion of the investigator. 11. Adequate hematologic, hepatic and renal function as assessed by the following laboratory requirements conducted within 28 days of enrollment:\n\na. Total bilirubin \\\u003C the upper limit of normal (ULN), unless the patient has documented Gilbert's disease for which the total bilirubin should be \\\u003C 3. b. Alanine aminotransferase and aspartate aminotransferase \\\u003C 2.5 of the ULN (\\\u003C 5 x of ULN for subjects with liver involvement of their cancer) c. Amylase and lipase \\\u003C 1.5 x of ULN d. Serum creatinine \\\u003C 1.5 x of ULN e. Glomerular filtration rate \\> 30ml\u002Fmin\u002F1.73 m2 according to the Modified Diet in Renal Disease abbreviated formula or creatinine clearance (CrCL) \\> 60 ml\u002Fmin (Cockcroft and Gault) or by 24 hour urine collection. f. International normalize ratio (INR) and the activated partial thromboplastin time (aPTT\u002FPTT) \\\u003C 1.5 x ULN. (Subjects who are therapeutically treated with an agent such LMWH or heparin will be allowed to participate provided that no prior evidence of an underlying abnormality in coagulation parameters exists) g. Platelet count \\> 100,000 cells\u002Fmm3, hemoglobin \\> 9 g\u002FdL, absolute neutrophil count \\> 1,500 cells\u002Fmm3 h. Alkaline phosphatase limit \\\u003C2.5 x ULN (\\\u003C5 x ULN for subjects with liver involvement of their cancer) i. Urine protein \\\u003C 30 mg\u002FdL. If urine protein is \\> 30 mg\u002FdL, a 24-hour urine collection will be required and must show total protein excretion \\\u003C1,000 mg per 24 hours or spot urine protein (mg\u002FdL) to creatinine (mg\u002FdL) ratio must be \\\u003C1.0.\n\n12\\. Left ventricular ejection fraction (LVEF) of \\> 50% by ECHO or MUGA within 56 days of enrollment. 13. Two readings of systolic blood pressure \\\u003C 140 mm Hg and diastolic blood pressure \\\u003C 90 mm Hg at screening taken at least 5 minutes apart in the sitting position after 5 minutes of rest. Subjects with well managed hypertension who are on oral antihypertensives must be on their current medication(s) and stable dose(s) for at least 2 weeks prior to enrollment.\n\nExclusion Criteria\n\n1. Prior treatment with or have known hypersensitivity to AL3818.\n2. a. Indication A - ASPS: Prior treatment with cediranib. b. Indication B - LMS: Prior treatment with or have known hypersensitivity to dacarbazine. (New Recruitment Suspended) c. Indication C - SS: Prior treatment with or have known hypersensitivity to dacarbazine.\n\n   d. Indication D - LMS: Prior treatment with anlotinib.\n3. Previous or concurrent cancer that is distinct in primary site or histology from ASPS, LMS, or SS within 5 years before enrollment except for successfully treated in situ carcinoma, non-melanoma skin cancer and superficial bladder tumors (Ta, Tis and T1).\n4. Received last dose of systemic cytotoxic therapy or investigational therapy within 21 days of enrollment or last dose of hormonal therapy, immunotherapy, targeted therapy or any other type of non-cytotoxic anti-cancer therapy within 14 days of enrollment.\n5. Prior treatment with extended-field radiotherapy (EFRT) within 28 days of enrollment or prior treatment with any other form of radiotherapy within 14 days of enrollment.\n6. Known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided that they are stable with no evidence of progression by imaging, and all neurologic symptoms have returned to baseline, and should not be using corticosteroids for at least 7 days prior to study treatment.\n7. Cavitary tumors or tumors invading or abutting large blood vessels in the thorax.\n8. History of gastrointestinal perforation, abdominal fistula or intra-abdominal abscess within 6 months of enrollment.\n9. Known history of bleeding disorders (e.g., von Willebrand disease or hemophilia).\n10. Clinically significant bleeding such as gross hematuria, gastrointestinal bleeding and hemoptysis within 6 months prior to enrollment.\n11. CTCAE version 4.03 \\> grade 2 pulmonary hemorrhage or \\> grade 3 of other forms of bleeding within 28 days prior to enrollment.\n12. History of untreated deep venous thrombosis (DVT) within the past 6 months. Patients with recent DVT who are treated with therapeutic anti-coagulating agents (excluding therapeutic warfarin which is exclusionary) for at least 14 days prior to start of study treatment.\n13. Use of aspirin (\\>325 mg\u002Fday) within 10 days prior to the first dose of study treatment.\n\n    The use of prophylactic therapeutic anti-coagulants are allowed provided that INR or aPTT are within therapeutic limits (according to the medical standard of the enrollment institution) and patient has been on a stable dose of anticoagulants for at least two weeks prior to the first dose of study treatment.\n14. Serious non-healing wound, active ulcer.\n15. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment or minor surgical procedure within 7 days of enrollment.\n16. CTCAE version 4.03 \\> grade 3 peripheral neuropathy\n17. Any unrecovered toxicity reactions of CTCAE version 4.03 \\> grade 1 caused by any previous therapy (excluding alopecia and neurotoxicity \\\u003C grade 2)\n18. QTcF \\> 470 msec (per Fridericia's formula) on electrocardiogram within 28 days of enrollment.\n19. Severe and uncontrolled disease, including:\n\n    1. Class I and above myocardial ischemia or myocardial infarction, cardiac arrhythmia and Class 2 or above congestive heart failure classified according to New York Heart Association (NYHA)\n    2. Active or failed to control serious infections (CTCAE version 4.03 \\> grade 2 infections)\n    3. Liver disease such as cirrhosis of the liver, decompensated liver disease, chronic active hepatitis needing anti-viral therapy\n    4. Renal failure needing hemodialysis or peritoneal dialysis\n    5. Poorly controlled diabetes (HgA1C \\>8)\n    6. Untreated and uncontrolled epileptic seizures\n    7. History of psychotropic drug abuse and inability to quit\n    8. Untreated psychiatric disorders\n20. Known HIV-positive\n21. Had organ transplantation\n22. Clinical conditions affecting the intake and use of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction)\n23. Females who are pregnant or are breast-feeding.\n24. Concomitant treatment with strong inhibitors or inducers of CYP1A2, CYP3A4 or CYP3A5; or sensitive substrates with narrow therapeutic index (TI) of CYP3A4, CYP2C9 and CYP2C19; or QT prolongating medications within 14 days prior to enrollment and during the study unless there was an emergent or life-threatening medical condition that required it.\n25. Any medical intervention, condition or any other circumstance which in the opinion of the investigator or the sponsor's medical monitor, could compromise adherence to study procedures or study objectives.","18 Years",{"count":149,"type":21},325,[151],"PHASE3","THIS STUDY IS CURRENTLY RECRUITING PATIENTS WITH ALVEOLAR SOFT PART SARCOMA ONLY AND IS NO LONGER RECRUITING PATIENTS WITH SYNOVIAL SARCOMA OR LEIOMYOSARCOMA.\n\nThis study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.",[33,154,30,155],"Leiomyosarcoma","Soft-Tissue Sarcoma","2026-02-23",{"date":158,"type":50},"2026-02-25",{"date":160,"type":50},"2017-08-15",{"date":162,"type":21},"2028-12",{"name":164,"class":137},"Advenchen Laboratories, LLC",24,{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":147,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":177,"conditions":178,"keywords":185,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100360033","multimodal-immune-characterization-of-rare-soft-tissue-sarcoma---miras-project-from-sarra-sarcome-rare-project-of-the-french-sarcoma-group-100360033","NCT03967834","Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group","MIRAS","Inclusion Criteria:\n\n1. Age ≥18 years at the time of study entry.\n2. Diagnosis of one of the following rare sarcoma subtype, confirmed by RRePS network:\n\n   * Clear Cell Sarcoma (CCS)\n   * Epithelioid Sarcoma (ES)\n   * Perivascular Epithelioid Cell neoplasm (PEComa)\n   * Desmoplastic Small Round Cell Tumours (DSRCT)\n   * Malignant Solitary Fibrous Tumours (mSFT)\n   * Alveolar Soft Part Sarcoma (ASPS)\n   * Epithelioid Hemangioendothelioma (EH)\n   * Low-Grade Fibromyxoid Sarcoma (LGFS)\n   * Sclerosing Epithelioid Fibrosarcoma (SEF).\n3. Localized\u002Flocally advanced or metastatic disease.\n4. In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).\n5. In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion.\n6. Patient followed in the center within a standard of care procedure or clinical trial.\n7. Archived tumor specimen at initial diagnosis available (before treatment initiation).\n8. Evaluable disease (measurable as per RECIST 1.1) or not.\n9. ECOG Performance status 0-3.\n10. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.\n11. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Diagnosis of all other histotypes of soft tissue sarcoma.\n2. Any condition contraindicated with procedures required by the protocol.\n3. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.\n5. Pregnant or breast-feeding woman.\n6. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship.",{"count":174,"type":21},400,[176],"NA","This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype.\n\n400 patients will be included in this prospective cohort study; they will be identified in the investigating centers in the context of either routine care or a clinical study protocol.\n\nRetrospective cases of patients (100 cases in total) will be identified in all centers through the GSF\u002FGETO clinical databases already setted up (including the clinical base Conticabase).",[179,32,37,180,34,181,33,182,183,184],"Soft Tissue Sarcoma","Perivascular Epithelioid Cell Neoplasms","Malignant Solitary Fibrous Tumors","Epithelioid Hemangioendothelioma","Low Grade Fibromyxoid Sarcoma","Sclerosing Epithelioid Fibrosarcoma",[179,32,37,180,34,181,33,182,183,184],"2026-02-09",{"date":188,"type":50},"2026-02-10",{"date":190,"type":50},"2021-04-26",{"date":192,"type":21},"2031-04",{"name":194,"class":57},"Institut Claudius Regaud",20,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":147,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100439243","phase-1-ab122-platform-study-100439243","NCT04999761","AB122 Platform Study","Platform Study of AB122 Based Treatments in Patients with Advanced Solid Tumors","Inclusion Criteria:\n\n* Is male or female aged ≥ 18 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2);\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;\n* Has adequate organ function as defined by the following criteria:\n\n  * AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN\n  * T-Bil of ≤ 1.5 × ULN\n  * ANC ≥ 1500 \u002Fmm3 (ie, ≥ 1.5 × 109 \u002FL by International System of Units \\[SI\\]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor \\[G-CSF\\])\n  * Platelet count ≥ 100000 \u002Fmm3 (SI: ≥ 100 × 109 \u002FL) (excluding measurements obtained within 7 days after a transfusion of platelets)\n  * Hemoglobin value of ≥ 9.0 g\u002FdL excluding measurements within 4 weeks after a transfusion of packed red blood cells (RBCs) or whole blood\n* Has a life expectancy of at least 90 days;\n\nCohort A-1 and A-2\n\n* Japanese male and female;\n* Has a histologically or cytologically confirmed diagnosis of solid tumor;\n* Has disease progression after standard treatment for advanced or metastatic disease, are intolerant to the standard treatment;\n\nCohort B-1\n\n* Has a histologically or cytologically confirmed diagnosis of PDAC;\n* Has disease progression after or intolerant to one prior systemic chemotherapy for advanced or metastatic disease\n\nCohort B-2\n\n* Has a histologically or cytologically confirmed diagnosis of CRC.\n* Has been received one regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the chemotherapy\n\nCohort B-3 - Has a histologically or cytologically confirmed non-squamous NSCLC;\n\n* Has been received one or two regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the standard treatment\n* Has been most recently received regimen including an ICI (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies) and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotherapy followed by checkpoint inhibitor therapy), and all of the following criteria must be met:\n\n  * Received at least 2 doses at the most recent ICI therapy\n  * Radiographic complete response or partial response based on investigator assessment with ICI therapy\n  * Documented radiographic disease progression with above most recently received regimen\n\nCohort C-1\n\n* Has unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer as pathologically confirmed adenocarcinoma\n* Gastroesophageal junction cancer is defined as a tumor with an epicenter that is located within 2 cm proximal to and distal from the esophagogastric junction (the boundary of esophageal and gastric muscularis).\n* Has received 2-4 standard regimens listed below and has demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose (The patient is eligible if the treatment is discontinued owing to SAEs, allergic reactions, or neurotoxicities.):\n\n  * fluoropyrimidines and platinum\n  * taxane or irinotecan\n  * ramucirumab\n\nCohort C-2\n\n* Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded)\n* RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy; Wild type is defined as v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) (exon 2, 3 and 4) and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) (exon 2, 3 and 4) wild type. \\[Mutant is defined as at least KRAS or NRAS mutant (any exon, any mutation)\\].\n* Has received at least 2 prior chemotherapy regimens for the treatment of advanced CRC and had demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose , or intolerance to their last regimen, and all of the following criteria must be met:\n\n  * Prior treatment regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody\n  * For RAS wild-type patients, an anti-EGFR monoclonal antibody must have included in addition to above\n\nCohort D-1\n\n* Has histologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory.\n\nCohort D-2\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-3\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease, or refractory or intolerant to at least 1 cycle of standard first-line therapy.\n\n  * Treatment discontinued due to intolerable toxicity or because the same drug cannot be re-treated before the disease progresses is considered as intolerable to the previous treatment.\n  * Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-4\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  * The confirmed status of the human papillomavirus (HPV) in cancers of the mid-pharynx.\n  * Patient background such as combined positive score (CPS) and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-5\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  * The confirmed status of the HPV in cancers of the mid-pharynx.\n  * Patient background such as CPS and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-6\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous NSCLC.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-7\n\n* Has histologically confirmed unresectable or advanced biliary tract cancer (intrahepatic bile duct, extrahepatic bile duct, gallbladder, or duodenal papillary region) with a diagnosis of adenocarcinoma or adenosquamous carcinoma.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-8\n\n* Has histologically confirmed unresectable or advanced pancreatic ductal adenocarcinoma (highly differentiated, moderately differentiated, or poorly differentiated).\n* No prior therapy for advanced or metastatic disease. Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort E-1\n\n* Has a histologically or cytologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory (except for tolerability part).\n* Has been received 1-4 regimen for advanced or metastatic disease\n* Has been received one regimen of ICI monotherapy or combination therapy (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies), and all of the following criteria must be met:\n\n  * Received at least 2 doses of the ICI therapy\n  * Documented radiographic disease progression with or after ICI therapy\n\nCohort E-2\n\n* Has a histologically or cytologically confirmed advanced or metastatic ASPS\n* Is male or female aged ≥ 16 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedure\n\nExclusion Criteria:\n\n* History or current evidence of cardiac arrhythmia and\u002For conduction abnormality: Any factor that can increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, etc.;\n* Treatment with any of the following within the specified time frame prior to the day on which study treatment is scheduled to be started:\n\n  * Major surgery within 4 weeks (the surgical incision should be fully healed prior to the day on which study treatment is scheduled to be started);\n  * Extended-field radiotherapy within 4 weeks or limited-field radiotherapy within 2 weeks;\n  * Any anticancer therapy within 2 weeks;\n  * Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever shorter;\n* Unresolved toxicity of ≥ Grade 2 attributed to any prior therapies (excluding anemia, peripheral sensory neuropathy, alopecia and skin pigmentation);\n* A serious illness or medical condition(s) including, but not limited to, the following specific medical conditions:\n\n  * Known acute systemic infection;\n  * Known medical history of interstitial lung disease\u002F drug-induced interstitial lung disease\u002F radiation pneumonitis which required steroid treatment\u002F any evidence of clinically active interstitial lung disease;\n  * Myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV, Appendix A) within the previous 6 months; if \\> 6 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms;\n  * Known severe chronic kidney disease;\n  * Known positivity of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody in baseline virus test. In addition, the patient who is known negative in HCV ribonucleic acid (RNA) is eligible, even if positive for HCV antibody;\n  * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment, or may interfere with the interpretation of study results, and in the judgment of the investigator or sub-investigator would make the patient inappropriate for entry into this study;\n* Previous or concurrent cancer that is distinct in primary disease or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia, or any cancer curatively treated \\> 5 years prior to the day on which study treatment is scheduled to be started;\n* WOCBP or male patients who do not agree to effective birth control during the following period\n\n  1. WOCBP patients: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n  2. Male patients with WOCBP partners: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n* Prior treatment with an anti-PD-L1 anti-PD-1, anti-CTLA-4, or other ICI or agonist as monotherapy or in combination (except for cohort B-3, C-1, D-1 tolerability part and E-1).\n* Has received a live vaccine within 30 days prior to study treatment including, but not limited to the following examples: measles, mumps, rubella, varicella-zoster, yellow fever, and BCG. The inoculation with inactivated vaccines for seasonal influenza is allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 28 days by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to enrollment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient\\'s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. (eg, paresis of intestine, intestinal obstruction, unable to receive 5% dextrose in water \\[DW\\] in patients with diabetes mellitus, respiratory failure, renal failure, hepatic failure, cerebrovascular disorder, gastrointestinal ulcers that require transfusion or are hemorrhagic, and wounds\u002Fbone fractures associated with neovascularization during the healing process, accumulation of pleural within 2 weeks prior to enrollment, ascitic, or pericardial fluid requiring drainage)",{"count":204,"type":21},917,[24],"This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.",[208,209,210,211,212,33,213,214,215],"Advanced or Metastatic Solid Tumor","Pancreatic Ductal Adenocarcinoma","Colorectal Cancer","Non-small Cell Lung Cancer","Gastric Cancer","Esophageal Cancer","Head and Neck Cancer","Biliary Tract Cancer","2024-09-23",{"date":218,"type":50},"2024-09-25",{"date":220,"type":50},"2021-06-01",{"date":222,"type":21},"2026-05",{"name":224,"class":137},"Taiho Pharmaceutical Co., Ltd.",9,{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":233,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":4},"100556576","evaluation-of-chest-ct-versus-chest-x-ray-for-lung-surveillance-after-curative-intent-resection-of-high-risk-truncal-extremity-soft-tissue-sarcoma-100556576","NCT06526897","Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","A Phase III Randomized Controlled Trial of Chest CT vs Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Patient must be ≥ 1 and ≤ 85 years old on the day of randomization\n* Patient must have and undergone curative-intent (R0 or R1) resection of an American Joint Committee on Cancer (AJCC) 8th edition stage III truncal or extremity soft tissue sarcoma\n* Patient must have a high-risk (grade 2 or 3) soft tissue carcinoma according to the French Federation of Cancer Centers Sarcoma Group (FNCLCC)\n\n  * Patients with the following histiotypes are eligible: dedifferentiated liposarcoma, pleomorphic liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, myxofibrosarcoma, fibrosarcomatous dermatofibrosarcoma protuberant variant, spindle cell sarcomas, pleomorphic sarcoma, fibrosarcoma,extra-skeletal myxoid chrondrosarcoma, extraskeletal Ewing and Ewing-like sarcoma, sarcoma not otherwise specified (NOS), or other grade 2 or grade 3 sarcomas not further classified\n  * Patients with a high-risk histiotype that is typically not graded, including adult pleomorphic rhabdomyosarcoma, synovial sarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma, epithelioid sarcoma, or clear cell sarcoma are eligible\n* Patient must have a tumor size ≥ 5 cm\n* Patient must have had a R0 or R1 oncologic resection on final pathologic report\n* Patient must have a baseline chest CT obtained within 30 days prior to randomization that is negative or detecting only non-suspicious nodules ≤ 4 mm\n* Patients receiving preoperative or post-operative chemotherapy and\u002For radiotherapy for the primary tumor are eligible. However, all chemotherapy and\u002For radiotherapy must be completed prior to randomization\n* Patient must not be pregnant due to the potential harmful risks associated with CXR and CT imaging to the unborn fetus\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not have a chest wall\u002Fupper truncal primary tumor requiring locoregional surveillance with CT or magnetic resonance imaging (MRI)\n* Patient must not have retroperitoneal, mesenteric\u002Fabdominal sarcoma\n* Patient must not have a primary bone sarcoma (including osteosarcomas, Ewings sarcoma, or chondrosarcomas), desmoid tumor, gastrointestinal stromal tumor (GIST), Kaposi sarcoma, pediatric rhabdomyosarcoma, nor uterine sarcoma\n* Patient must not have had a palliative or R2 resection\n* Patient must not require routine cross-sectional imaging of the chest\u002Flungs with CT\u002FMRI\u002Fpositron emission tomography (PET)\n* Patient must not have participation in another clinical trial that is incompatible with this study surveillance schema and follow-up regimen\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Pediatric patients (\\\u003C 18 years of age) and patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible. Child assent must be obtained as appropriate in accordance with institutional guidelines\n* Patient must be English speaking to be eligible for the quality of life (QOL) component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms","1 Year","85 Years",{"count":236,"type":21},1582,[176],"This phase III trial compares chest computed tomography (CT) to chest x-ray (CXR) for lung surveillance after curative-intent resection of high-risk truncal-extremity soft tissue sarcoma. Currently, complete oncologic resection (with or without radiation therapy) is the standard of care for most high-risk soft tissue sarcoma that has not spread to other parts of the body (localized). However, despite curative-intent resection, 20-40% of patients will develop cancer that has spread from where it first started (primary site) to other places in the body (distant metastases), with the lungs being the most common site. Thus, lung surveillance is important for detection of lung metastases in order to facilitate timely treatment. Although there is general agreement about the usefulness of postoperative surveillance, consensus is lacking regarding the optimal modality for lung surveillance after curative-intent resection for high-risk soft tissue sarcoma. Current National Comprehensive Cancer Network guidelines recommend chest imaging with CT or CXR every 3-6 months for 2-3 years, then every 6 months for the next two years, and then annually after that for high-risk tumors. Data from across the United States and internationally indicate that there is considerable variation in clinical practice with regards to the use of CXR versus CT chest for lung surveillance. The information gained from this trial may allow researchers to determine the effectiveness of varying imaging modalities needed for optimal surveillance for patients with extremity or truncal soft tissue sarcoma.",[240,241,242,33,243,244,245,246,247,248,249,154,250,96,251,252,95,179,253,254,255,30,97],"Adult Pleomorphic Rhabdomyosarcoma","AJCC Grade 2 Sarcoma","AJCC Grade 3 Sarcoma","Angiosarcoma","Clear Cell Sarcoma of Soft Tissue","Dedifferentiated Liposarcoma","Extraskeletal Ewing Sarcoma","Extraskeletal Myxoid Chondrosarcoma","Fibrosarcoma","Fibrosarcomatous Dermatofibrosarcoma Protuberans","Malignant Peripheral Nerve Sheath Tumor","Pleomorphic Liposarcoma","Round Cell Sarcoma With EWSR1-non-ETS Fusion","Soft Tissue Sarcoma of the Trunk and Extremities","Spindle Cell Sarcoma","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","NOT_YET_RECRUITING","2024-07-24",{"date":259,"type":50},"2024-07-30",{"date":261,"type":21},"2025-01-28",{"date":263,"type":21},"2032-11-01",{"name":265,"class":82},"ECOG-ACRIN Cancer Research Group"]