[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sarcomasoft-tissue\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sarcomasoft-tissue":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,46,69,102,133,156,184,210,238,265,286,321,354,378,405,435,456,483,501],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100452168","phase-2-preoperative-imrt-with-anlotinib-and-penpulimab-for-localized-sarcoma-spare-01-100452168",false,"NCT05167994","Preoperative IMRT With Anlotinib and Penpulimab for Localized Sarcoma （SPARE-01）","Preoperative Intensity-Modulated Radiotherapy (IMRT) Combined With Concurrent Anlotinib Hydrochloride and Penpulimab for Localized Extremity or Trunk Sarcoma","SPARE-01","Inclusion Criteria:\n\n* Age older than 18-yo\n* Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.\n* ECOG 0-3\n* Histology reviewed by reference pathologist\n* Lesion can be assessed\n* Can tolerate radiotherapy and Anlotinib\n* Agree contraception.\n* Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed\n\nExclusion Criteria:\n\n* No gross tumor post-resection in other center.\n* Contraindications to Anlotinib, including allergic to Anlotinb, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.\n* Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.\n* Benign histology\n* Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)\n* STS can be cured by extensive operation alone.\n* Previous irradiation to the same area\n* Radiological evidence of distant metastases\n* Other contraindications, can't tolerate operation or other treatment needed in this study.\n* Neoadjuvant chemotherapy given or planned.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","To investigate the safety and efficacy of preoperative IMRT and concurrent Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Anlotinib Hydrochloride and Penpulimab for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.",[27,28,29,30,31,32],"Sarcoma,Soft Tissue","Extremity","Trunk","Anlotinib","Intensity-modulated Radiotherapy","Major Wound Complications","RECRUITING","2026-06-03",{"date":36,"type":37},"2026-06-04","ACTUAL",{"date":39,"type":37},"2020-05-01",{"date":41,"type":21},"2027-12-31",{"name":43,"class":44},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":45},"100408999","phase-2-pemetrexed-cisplatin-with-soft-tissue-sarcoma-100408999","NCT04605770","Pemetrexed, Cisplatin With Soft Tissue Sarcoma","A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Pemetrexed\u002FCisplatin Chemotherapy for Patients With Metastatic\u002FRecurrent Soft Tissue Sarcoma in 4- Independent Histologic Subtypes","ALBATROSS","Inclusion Criteria:\n\n* histologically confirmed, advanced\u002Fmetastatic STS\n* Is ≥ 19 years of age\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n* measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1\n* laboratory values indicating adequate organ function\n* a documented postmenopausal woman, or is a premenopausal woman with negative urine or serum pregnancy test\n* life expectancy ≥ 12 weeks\n\nExclusion Criteria:\n\n* previously received more than 2 regimens of cytotoxic chemotherapy\n* received chemotherapy, surgery to major organ, or radiotherapy within the last 2 weeks\n* ongoing toxicity (≥ CTCAE grade 2) from previous anticancer therapy\n* central nervous system (CNS) metastases requiring active treatment\n* diagnosis of second malignancy or has a history of active malignancy within the past 3 years\n* other medical conditions where the study treatment is intolerable\n* history of active infection\n* hypersensitivity to pemetrexed or any of its excipients\n* Co-administration with yellow fever vaccine\n* pregnancy","19 Years",{"count":56,"type":21},164,[24],"Soft tissue sarcoma (STS) is rare malignancy of mesodermal origin, representing less than 1% of all malignant neoplasms. They are a group of diseases encompassing diverse histological subtypes with very different biomorphologies, prognoses, and responses to treatments. At advanced stages of STS, anticancer treatments are less effective and the prognosis is poor with a median survival of 8 to 18 months. Doxorubicin and ifosfamide given each alone or in their combination have represented the mainstream of anticancer treatments in metastatic STS. However, salvage treatments for patients with progression after doxorubicin\u002Fifosfamide-based treatment are limited and anticancer agents such as gemcitabine\u002Fdocetaxel, pazopanib, eribulin and trabectedin are currently used as a standard of care (SOC).\n\nFor metastatic sarcoma, a study of pemetrexed alone in patients with refractory STS who have progressed after doxorubicin and\u002For ifosfamide-based anticancer treatment was conducted. In this study including 48 patients, most of whom had relatively poor course of disease with disease progression after the 2nd- and\u002For 3rd-line treatment, pemetrexed was well tolerated and associated with 5% of response rate and 33% of 3-month progression-free rates suggesting potential antitumor efficacy with good tolerability profile with refractory STS.\n\nHowever, as conventional agents have showed different efficacy depending on various subtypes of STS, a confirmatory study to see clinical utilities of a given regimen by subtype is required also for pemetrexed\u002Fcisplatin. Therefore, the investigators intend to proceed this phase 2 clinical trial to evaluate the efficacy and safety of pemetrexed\u002Fcisplatin combination therapy in patients with advanced\u002Fmetastatic STS who received up to two-lines of prior palliative anticancer treatments with histological subtype-specific cohorts (leiomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumor, and others) in order to provide a basis for a subsequent phase 3 study by selecting histological subtype(s) in which the efficacy of study regimen is to be proven.",[27],"2026-04-27",{"date":62,"type":37},"2026-04-30",{"date":64,"type":37},"2020-12-22",{"date":66,"type":21},"2027-11-01",{"name":68,"class":44},"Yonsei University",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":45},"100406791","phase-1-retifanlimab-anti-pd-1-antibody-with-gemcitabine-and-docetaxel-in-patients-with-advanced-soft-tissue-sarcoma-100406791","NCT04577014","Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma","A Multi-cohort Study of Retifanlimab With or Without Gemcitabine and Docetaxel in Patients With Advanced Sarcoma","Inclusion Criteria:\n\n* Diagnosis of metastatic or locally advanced and unresectable high-grade soft tissue sarcoma. Unresectable is defined as:\n\n  1. primary tumor cannot be safely removed surgically, or\n  2. primary tumor would benefit from systemic therapy prior to a surgical approach\n* Be willing and able to provide written informed consent\n* Must consent to mandatory tumor biopsy (if deemed safe and feasible) for research studies at screening, if archival tissue is not available, and at C1D15, C3D15.\n* Age ≥ 18 years\n* ECOG performance status ≤ 1\n* Presence of measurable disease per RECIST v1.1\n\n  * Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and\u002For pathologically documented tumor progression in that lesion prior to enrollment.\n* No prior systemic therapy (see exclusion criteria, below)\n* Negative serum pregnancy test in women of childbearing potential\n* Patients with chronic HBV (HBsAg-positive with undetectable or low HBV DNA and normal ALT, or HBsAg-negative with anti-HBc-positive serology) and HCV (completed curative antiviral treatment with HCV viral load below the limit of quantification) may be eligible\n\n  * Patients with HBV should be treated with suppressive antiviral therapy prior to enrollment\n  * Patients with HCV must have completed curative therapy and have negative HCV viral load\n* Adequate organ function, as defined in Table 2:\n\nTable 2: Laboratory Parameters Required for Study Inclusion\n\nHematological Absolute neutrophil count (ANC): ≥ 1,500 \u002FmcL Platelets: ≥ 75,000 \u002F mcL Hemoglobin: ≥ 9g\u002FdL or ≥ 5.6 mmol\u002FL\n\nRenal Serum creatinine: ≤ 1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance: ≥ 60 mL\u002Fmin for patient with creatinine levels \\> 1.5 X institutional ULN (GFR can also be used in place of creatinine orCrCl)\n\nHepatic Serum total bilirubin: ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 ULN except patients with Gilbert's disease (≤ 3x ULN) AST (SGOT) and ALT (SGPT): ≤ 2.5 X ULN OR ≤ 5 X ULN for patients with liver metastases\n\nExclusion Criteria:\n\n* Received any systemic therapy in the advanced or metastatic setting\n\n  * Adjuvant or neoadjuvant therapies received ≥ 1 year prior to enrollment are permitted\n* Unstable or deteriorating cardiovascular disease within the previous 6 months, including:\n\n  * Unstable angina or myocardial infarction\n  * CVA\u002Fstroke\n  * New York Heart Association \\[NYHA\\] Class III or IV congestive heart failure\n  * Uncontrolled clinically significant arrhythmias\n* Current use of immunosuppressive medication, EXCEPT for the following:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)\n  * Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* Evidence of clinically significant immunosuppression such as the following:\n\n  * Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease\n  * Concurrent opportunistic infection\n  * Receiving systemic immunosuppressive therapy (\\> 2 weeks) including oral steroid doses \\> 10 mg\u002Fday of prednisone or equivalent within 2 months prior to enrollment\n* History or evidence of symptomatic autoimmune disease in past 2 years prior to enrollment.\n\n  * Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease\n* Uncontrolled HIV infection, as defined by one or more of the following:\n\n  * Patients with CD4+ T-cell (CD4+) counts \\\u003C 350 cells\u002FuL\n  * Patients with a history of an opportunistic infection secondary to AIDS\n  * Patients on anti-microbials with drug-drug interactions with the study drugs on this protocol, who cannot be switched to alternative anti-microbials\n  * Patients on antiretroviral therapy \\\u003C 4 weeks\n  * Patients with HIV viral load \\> 400 copies\u002FmL\n* Active Hepatitis B or Hepatitis C\n* Patients who have received a live vaccine within 30 days of the start date of the planned study therapy (with the exception of COVID-19 vaccines)\n* History of active TB (Bacillus Tuberculosis)\n* Radiation therapy within 2 weeks prior to study day 1\n* If patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy\n* Women who are pregnant or breast feeding\n* Patients expecting to conceive or father children within the projected duration of the trial, starting with the visit through 180 days after the last dose of study treatment(s)\n* Prior organ transplantation including allogenic stem-cell transplantation\n* Active infection requiring systemic therapy\n* Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3)\n* Patients with prior history of interstitial lung disease and clinically significant pulmonary compromise, including those who have a requirement for supplemental oxygen use to maintain adequate oxygenation",{"count":77,"type":21},98,[79,24],"PHASE1","This study is being done to find out whether the study drug Retifanlimab, a monoclonal antibody against the PD-1 protein, combined with gemcitabine and docetaxel, is a safe and effective treatment for your disease. Gemcitabine and docetaxel are chemotherapy drugs that are commonly used to treat soft tissue sarcoma. Retifanlimab is an experimental drug that boosts the immune system's ability to fight cancer cells. The study researchers think that Retifanlimab may help gemcitabine and docetaxel work better against soft tissue sarcoma that is either locally advanced or has spread beyond its original location (metastasized), and it cannot be removed with surgery (unresectable).",[82,27,83,84],"Soft Tissue Sarcoma","Sarcoma","Soft Tissue Sarcoma Adult",[86,87,88,89,90,91,92,93],"soft tissue sarcoma","locally advanced soft tissue sarcoma","unresectable soft tissue sarcoma","metastasized soft tissue sarcoma","sarcoma","Retifanlimab","20-316","Memorial Sloan Kettering Cancer Center","2026-04-13",{"date":96,"type":37},"2026-04-14",{"date":98,"type":37},"2020-09-29",{"date":100,"type":21},"2026-09-29",{"name":93,"class":44},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":112,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100547474","the-epithelioid-hemangioendothelioma-registry-of-the-european-reference-network-on-rare-adult-solid-cancers-euracan-100547474","NCT06408441","The Epithelioid Hemangioendothelioma Registry of the European Reference Network on Rare Adult Solid Cancers (EURACAN)","The Observational EURACAN Prospective Clinical Registry Dedicated to Epithelioid Hemangioendothelioma: the Protocol of an International and Collaborative Effort on an Ultra-rare Entity","EHE","Inclusion Criteria:\n\n* New patients managed by the contributing centers with a pathological EHE diagnosis performed or verified by an expert sarcoma pathologist starting from 1 December 2023 onwards and to be performed within 6 months from the registration\n* Molecular confirmation of the diagnosis (WWTR1-CAMTA1 or YAP1-TFE3)\n* Adult patients (aged ≥ 18 years)",{"count":111,"type":21},100,"6 Months","OBSERVATIONAL","Epithelioid hemangioendothelioma (EHE) is an ultra-rare sarcoma, marked by distinctive molecular and pathological features and with a variable clinical behavior. Its natural history is still partially understood, reliable prognostic and predictive factors are lacking and many questions are still open on the optimal management. In the context of EURACAN, a prospective registry specifically dedicated to EHE was developed and launched with the aim of providing, through high-quality prospective data collection, a better understanding of this disease.\n\nThe study design is a registry-based cohort study including only new cases of patients with a pathological and molecularly confirmed diagnosis of EHE.\n\nThe objectives are to improve the understanding of EHE natural history, validate and identify new prognostic and predictive factors, clarify the activity and efficacy of currently available treatment options, describe treatment pattern.\n\nIt is an hospital-based registry established in centres with expertise in EHE including adult patients with a new pathological and molecularly confirmed diagnosis of EHE starting from the 1st December 2023. The characteristics of each patient in the facility who meets the above-mentioned inclusion criteria will be collected prospectively and longitudinally with follow-up at cancer progression and \u002F or cancer relapse or patient death.\n\nThe data analyses will include descriptive statistics and analytical analyses. Multivariable Cox's proportional hazards model and Hazard ratios (HR) for all-cause or cause-specific mortality will be used to determine independent predictors of overall survival, recurrence and progression.\n\nThe registry has been joined by 21 sarcoma reference centers across EU and UK, covering 10 countries. Patients' recruitment started in December 2023. The estimated completion date is December 2033 upon agreement on the achievement of all the registry objectives. The already established collaboration and participation of EHE patient's associations involved in the project will help in promoting the registry and fostering accrual.\n\nThis registry has been developed with the support of EHE Rare Cancer Charity UK, STATER (Grant Agreement number: 947604, HP-PJ-2019) and EURACAN 2022 (Grant Agreement number: 101085486, EU4H-2022-ERN-IBA) European Health and Digital Executive Agency (HaDEA)",[116,27],"Epithelioid Hemangioendothelioma",[118,119,120,121,122],"rare cancers","soft tissue rare cancer","registry","protocol","ultra rare sarcomas","2026-03-30",{"date":125,"type":37},"2026-04-03",{"date":127,"type":37},"2023-12-01",{"date":129,"type":21},"2033-12-01",{"name":131,"class":44},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",22,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":45},"100379332","neoadjuvant-irradiation-of-retroperitoneal-soft-tissue-sarcoma-with-ions-retro-ion-100379332","NCT04219202","Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion","Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie","Retro-Ion","Inclusion Criteria:\n\n* Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable\n* Karnofsky index of ≥ 70%\n* Age from 18 years\n* Completed patient information and written consent\n* ability to give consent\n\nExclusion Criteria:\n\n* Stage IV (distant metastases)\n* Lymphogenic metastasis\n* Metal implants at the level of the sarcoma, which influence the treatment planning\n* Previous radiation therapy in the treatment area\n* Desmoid tumors, peritoneal sarcomatosis, GIST\n* Simultaneous participation in another clinical study that could influence the results of the respective study\n* Active medical implants for which there is no license for ion irradiation at the time of treatment (e.g. pacemaker, defibrillator)\n* Pregnant women",{"count":142,"type":21},64,[144],"NA","The study is a randomized, open, prospective phase II study. The aim of the study is to evaluate the safety and feasibility of a hypofractionated, accelerated radiation approach based on the incidence of grade 3-5 NCI Common Terminology Criteria for Adverse Events (NCI-CTC-AE ) toxicity and \u002F or termination of the planned therapy for any reason with neoadjuvant radiation with active beam guidance of the retroperitoneal Sarcomas using protons or carbon ions before a subsequent tumor resection.",[27],"2026-03-06",{"date":149,"type":37},"2026-03-10",{"date":151,"type":37},"2019-05-09",{"date":153,"type":21},"2027-05-09",{"name":155,"class":44},"University Hospital Heidelberg",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":45},"100570837","phase-2-bacterial-decolonization-plus-intraoperative-angiography-for-soft-tissue-sarcomas-receiving-preoperative-radiotherapy-concerto-100570837","NCT06712433","Bacterial Decolonization Plus Intraoperative Angiography for Soft Tissue Sarcomas Receiving Preoperative Radiotherapy (CONCERTO)","Bacterial Decolonization Plus Intraoperative Indocyanine Green Angiography for Soft Tissue Sarcomas of the Lower Extremity Receiving Preoperative Radiotherapy (CONCERTO)","CONCERTO","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n2. Newly diagnosed soft tissue sarcoma arising from the lower extremity (defined as the tumor center arising at the level of the iliac crest or below)\n3. Eligible for wide local excision\n4. Eligible for external beam radiation therapy\n5. Negative serum pregnancy test for women of childbearing potential \\\u003C 28 days prior to RT.\n6. Informed consent signed and dated to participate in the study.\n7. Willingness and ability to comply\n\nExclusion Criteria:\n\n1. Allergy to mupirocin and\u002For chlorhexidine\n2. Active dermatologic condition in RT field\n3. Tumor size \\> 32cm\n4. Prior RT overlapping with fields\n5. Concurrent\u002Fprior invasive malignancy that could potentially interfere with proposed treatment. Individual cases can be discussed with PI prior to registration",{"count":165,"type":21},31,[24],"This trial will investigate the combination of two low-cost, non-toxic strategies to assess whether they can reduce the risk of acute major wound complications in soft tissue sarcoma of the lower extremity. Intranasal mupirocin ointment twice daily and chlorhexidine body cleanser once daily for 5 days prior to radiation therapy and repeated for 5 days every 2 weeks during radiation therapy may significantly reduce the risk of acute radiation dermatitis. That, along with use of indocyanine green (ICG) angiography at the time of wound closure.",[27],[170,171,172,173],"bacterial decolonization (BD)","external beam radiotherapy (RT)","wide local excision (WLE)","intraoperative IICG angiography","NOT_YET_RECRUITING","2026-02-04",{"date":177,"type":37},"2026-02-09",{"date":179,"type":21},"2026-09-30",{"date":181,"type":21},"2028-09-30",{"name":183,"class":44},"Adam Olson",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":193,"studyType":113,"phases":4,"briefSummary":194,"conditions":195,"keywords":198,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100371937","gisar-german-interdisciplinary-sarcoma-registry-100371937","NCT04122872","GISAR German Interdisciplinary Sarcoma Registry","GISAR","Inclusion Criteria:\n\n* Histological verified bone or soft tissue sarcomas including bone and soft tissue tumors with borderline histological results or with unclear histological dignity like giant cell tumors of the bone (GCTB), desmoid tumors, atypical lipomatous tumors etc. - independent of therapy form and therapy line - or Histological verified sarcomatoid carcinomas\u002F carcinosarcomas: tumors with histological, cytological, or molecular properties of both epithelial tumors (\"carcinoma\") and mesenchymal tumors (\"sarcoma\") - independent of therapy form and therapy line.\n* Signed informed consent form or equivalent (s. chapter 10)\n* Age ≥18 years\n\nExclusion Criteria:\n\n* none",{"count":192,"type":21},9000,"10 Years","GISAR has an open and modular setup. It is sought to include as many German sarcoma and CS patients (i.e. sarcoma and CS patients treated in Germany) in the registry as possible. A basic data set should be collected on every included patient). In order to adress specific scientific questions, additionally detailed data can be collected in defined patient groups (e.g. effectiveness \u002F adverse effects of systemic therapies in defined situations) within the context of sub-project add-on modules. This data collection can be prospective or retrospective depending on the sub-project",[83,27,196,197],"Sarcoma of Bone","Carcinosarcoma",[83,82,196,199],"Registry","2026-02-03",{"date":202,"type":37},"2026-02-05",{"date":204,"type":37},"2018-11-29",{"date":206,"type":21},"2038-01",{"name":208,"class":44},"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest",21,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100580265","phase-2-feasibility-of-total-neoadjuvant-treatment-with-hyperthermia-in-patients-with-high-risk-extremity-and-trunk-soft-tissue-sarcoma-tnt-hype-100580265","NCT06835049","Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE)","Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE). A Multicenter, Single Arm, Open Label, Phase II Trial","TNT-HYPE","Main Inclusion Criteria:\n\n* Histologically confirmed primary high-risk Soft tissue sarcoma (STS) of extremity or trunk.\n* High-risk according to the prognostic Sarculator tool: 10-year OS probability \\\u003C 60%5.\n* Resectable tumor: resectability is based on pre-operative imaging and has to be defined by the local treating sarcoma team. A patient is not considered resectable when the expectation is that only a R2 resection is feasible.\n* Measurable disease per RECIST v1.1.\n* Diagnostic biopsy is available for the central pathology review.\n* Candidate for chemotherapy regimen according to protocol.\n* Candidate for loco-regional HT.\n* Adequate bone marrow function, hepatic function, renal function, cardiac function and coagulation function.\n\nMain Exclusion Criteria:\n\n* Metastatic disease.\n* Previous Whoops resection.\n* Ex-ulcerating tumors or tumors infiltrating the skin.\n* Other invasive malignancy within 5 years, with the exception of adequately treated non melanoma skin cancer, localized cervical cancer, localized and Gleason ≤ 6 prostate cancer.\n* Any previous radiotherapy (RT) or systemic therapy for the present tumor.\n* Previous treatment with maximum cumulative doses (450 mg\u002Fm² doxorubicin or equivalent 900 mg\u002Fm² epirubicin) of doxorubicin, daunorubicin, epirubicin, idarubicin, and\u002For other anthracyclines and anthracenediones.\n* Concomitant or recent (within 30 days of registration) treatment with any other experimental drug.\n* Concomitant use of other anti-cancer drugs or RT.\n* No metal implants in the region of tumor or cardiac implant electronic devices (CIEDs).\n* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last 12 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension.\n* Active and uncontrolled infections, in particular urinary tract infections.\n* Inflammation of the urinary bladder (interstitial cystitis).\n* History of cerebrovascular accident or intracranial hemorrhage within 6 months prior to registration.\n* Vaccination with live vaccines within 30 days prior to registration.\n* Known hypersensitivity to trial drug(s) or to any component of the trial drug(s).",{"count":219,"type":21},24,[24],"Soft tissue sarcomas (STSs) are rare cancers with a 5-year survival rate of 60%, and there is no standard treatment for high-risk extremity and trunk STSs (eSTS). A phase III trial suggests that adding moderate regional hyperthermia (HT) to anthracycline-based chemotherapy, followed by surgery and radiotherapy (RT), can improve 10-year overall survival by 10%. This trial aims to optimize treatment by combining the most effective regimens from chemotherapy, HT, RT, and surgery, and will evaluate the feasibility of this new total neoadjuvant treatment (TNT) approach.",[27],[224,216,225,226,227],"Sarcoma, soft-tissue","phase II","Neoadjuvant Treatment","hyperthermia","2025-12-23",{"date":230,"type":37},"2025-12-30",{"date":232,"type":37},"2025-10-27",{"date":234,"type":21},"2031-03-31",{"name":236,"class":44},"Swiss Cancer Institute",8,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":45},"100588422","preventive-application-of-single-use-negative-pressure-wound-therapy-snpwt-in-the-postoperative-course-of-radiotreatated-limb-sarcoma-surgery-100588422","NCT06941194","Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery","Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery a Randomized Clinical Trial","PRALISS","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age\n* diagnosis of primary high-grade (grade III) soft tissue sarcoma of the limbs (confirmed histopathologically)\n* performed neoadjuvant radiotherapy (short or long-term)\n* candidates for wide radical excision surgery\n* negative CT scan staging for distant metastasis\n* Signing of Informed consent\n\nExclusion Criteria:\n\n* diagnosis of benign neoplasm\n* diagnosis of retroperitoneal or trunk sarcomas;\n* candidates to hindquarter or forequarter amputation surgery;\n* incomplete wide excision;\n* vascular resection;\n* other loco-regional treatments (e.g. isolated limb perfusion or electrochemotherapy).","99 Years",{"count":248,"type":21},48,[144],"Patients will be recruited at the time of the pre-admission visit. During the screening visit the patient will undergo a physical examination and his medical history will be collected. Oncological history and tumor characteristics will be considered and CT-scan imaging will be analysed. ECOG performance status will be reported. If inclusion criteria are respected, the patient will be randomized. The application of the PICO14 study device or standard dressing (dry gauze and plaster) will then be carried out on the day of surgery. For subjects randomized to the treatment arm (Arm A), dressing change with the application of the new PICO14 will occur at day 4+1, day 8±1, and day 14±2. For subjects randomized to the control arm (Arm B), the standard dressing with gauze and plaster is applied. Regardless of the randomization arm the wound assessment via ASEPSIS score will occur at day 4+1, 8±1 and 14±2. During FUP, the dressing can be changed autonomously by the patient if necessary. The information will be recorded on the occasion of the next visit or an extraordinary visit. On day 21, sutures will be removed.\n\nOn day 30±2, the total ASEPSIS score will be calculated, in order to evaluate the wound healing.\n\nFrom day 14±2, regardless of the randomization arm all patients will be treated with standard dressing.\n\nFollow-up visits can be scheduled up to 90 days after surgery.",[83,27],[90,253,254,255],"limbs","high-grade (grade III) soft tissue sarcoma","PICO14","2025-12-01",{"date":258,"type":37},"2025-12-02",{"date":260,"type":37},"2025-09-15",{"date":262,"type":21},"2027-11",{"name":264,"class":44},"Istituto Oncologico Veneto IRCCS",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":282,"leadSponsor":284,"locationsCount":45},"100595051","phase-1-bold-100-plus-doxorubicin-in-advanced-soft-tissue-sarcomas-100595051","NCT07027423","BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas","A Phase 1b Trial of BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas","Inclusion Criteria\n\n1. Written informed consent in accordance with federal, local, and institutional guidelines.\n2. Age \\> 18 years.\n3. Patients must have histologically confirmed locally advanced\u002Funresectable or metastatic soft tissue sarcoma of limited subtype LMS, DDLPS and UPS (including Myxofibrosarcoma-MFS).\n4. Patients be systemic treatment naïve, with incurable, advanced or metastatic disease.\n5. Patient must have measurable disease as defined by RECIST 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate hematopoietic function:\n\n   1. total white blood cell (WBC) count ≥2000\u002Fmm3.\n   2. absolute neutrophil count (ANC) ≥1500\u002Fmm3.\n   3. platelet count ≥100,000\u002Fmm3.\n8. Adequate hepatic function:\n\n   1. Bilirubin \\\u003C2 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \\\u003C 3 times ULN).\n   2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C2.5 X ULN. In the case of known (radiological and\u002For biopsy documented) liver metastasis, ALT\u002FAST \\\u003C5.0 X ULN is acceptable.\n9. Adequate renal function defined as \\\u003C1.5x upper limits of normal\n10. Cardiac function: A normal left ventricular ejection fraction (LVEF) of \\> 50% as evidenced by an echocardiogram or nuclear medicine study performed within 28 days of the proposed study commencement.\n11. Female patients of childbearing potential must agree to use two methods of contraception (including one highly effective and one effective method of contraception) and have a negative serum pregnancy test at 72 hours prior to receiving the first dose of study medication. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment.\n\nExclusion Criteria\n\nSubjects should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Patient is pregnant or lactating.\n2. Radiation (except planned or ongoing palliative radiation outside of the region of measurable disease), chemotherapy, immunotherapy, any other systemic anticancer therapy, or participation in an investigational anti-cancer study ≤3 weeks prior to initiation of therapy.\n3. Major surgery within 4 weeks before initiation of therapy.\n4. Prior systemic therapy.\n5. Unstable cardiovascular function:\n\n   1. symptomatic ischemia, or.\n   2. uncontrolled clinically significant conduction abnormalities (e.g., ventricular tachycardia on anti-arrhythmic is excluded and 1st degree AV block or asymptomatic LAFB\u002FRBBB will not be excluded) or.\n   3. congestive heart failure (CHF) of NYHA Class ≥3, or.\n   4. myocardial infarction (MI) within 3 months of initiation of therapy.\n6. Active, ongoing or uncontrolled active infection within one week prior to first dose.\n7. Malignancies other than disease under study within 2 years prior to Cycle 1, Day 1, except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Prior chemotherapy is allowed apart from regimens that contained anthracycline based therapies.\n8. Known to be HIV seropositive.\n9. Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) RNA or hepatitis B virus (HBV) surface antigen (HBsAg).\n10. Patients with active CNS malignancy. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months.\n11. Serious psychiatric or medical conditions that could interfere with treatment.\n12. Concurrent therapy with approved or investigational anticancer therapeutic agents.\n13. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study regimen or interpretation of patient safety or study results.",{"count":273,"type":21},32,[79],"A Phase 1b, non-randomized, single-institution trial designed to assess the safety, tolerability and the highest dose with acceptable toxicity (RP2D) of BOLD-100 in combination with doxorubicin in patients diagnosed with advanced soft tissue sarcomas. The trial is divided into two phases: an initial dose-escalation phase for BOLD-100, followed by a dose-expansion phase based on the recommended dose for Phase 2. In the dose-escalation phase, we plan to enroll 12-15 patients, with an additional 17 patients in the dose-expansion phase.\n\nParticipants will receive BOLD-100 intravenously on Days 1 and 8 of a 21-day cycle, in combination with doxorubicin (75 mg\u002Fm², intravenous) administered on Day 1 of each 21-day cycle for up to six cycles. Participants will continue to receive BOLD-100 for as long as the cancer is not getting worse, The maximum cycles of doxorubicin are 6 cycles.\n\nParticipants will undergo a screening assessment prior to the start treatment to determine eligibility for enrollment. Treatment will commence on Day 1 and will continue until the protocol-defined criteria for treatment withdrawal are met. Disease response will be assessed using CT or MRI scans, starting at 12 weeks after the initiation of treatment and continuing every 12 weeks until withdrawal.\n\nUpon treatment discontinuation or study withdrawal, a post-treatment assessment will be conducted at end of treatment and at 30 days of the last BOLD-100 dose, with follow-up visits scheduled every 3 months thereafter.",[277,83,27,278],"Sarcoma, Soft-tissue","Sarcomas","2025-11-27",{"date":256,"type":37},{"date":123,"type":21},{"date":283,"type":21},"2027-01-29",{"name":285,"class":44},"University Health Network, Toronto",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":307,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":45},"100462046","phase-1-anti-ny-eso-1-tcr-gene-engineered-lymphocytes-given-by-infusion-to-patients-with-ny-eso-1--expressing-metastatic-cancers-100462046","NCT05296564","Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers","A Phase I\u002FII Dose Escalation, Safety and Efficacy Study of Anti-NY-ESO-1 T Cell Receptor (TCR)-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers","Inclusion Criteria:\n\n1. Have histologically or cytologically confirmed diagnosis of neoplasia\n2. Measurable (per RECIST v1.1 criteria) metastatic cancer or locally advanced refractory\u002Frecurrent malignancy not amenable to curative treatment. Lesions previously irradiated may be considered measurable only if growth has been documented since local treatment completion.\n3. The tumor expresses ESO as assessed immunohistochemistry of resected tissue. To this end, archived tumor tissue suitable for analysis must be available or re-biopsy performed on study. Tissue staining must encompass more than 10% of tumor section.\n4. Patients must have previously either (1) received at least first-line or second-line standard therapy for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease), intolerable or have recurred or (2) Recurred within 6 months of adjuvant systemic therapy known to be active also in the metastatic setting.\n5. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n6. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).\n7. Age ≥ 18 years and ≤ 70 years.\n8. Patient is able to understand and willing to sign a written informed consent.\n9. Clinical performance status of ECOG 0, 1 or 2.\n10. HLA-A\\*0201or A\\*0206 positive.\n11. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment.\n12. Women of child-bearing potential must have a negative pregnancy test.\n13. Serology: Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n14. Hematology\n\n    * ANC \\> 1500\u002Fmm3 without the support of filgrastim\n    * WBC ≥ 3000\u002Fmm3\n    * Platelet count ≥ 100,000\u002Fmm3\n    * Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n15. Chemistry\n\n    * Serum ALT\u002FAST ≤ 2.5 x ULN\n    * Creatinine clearance ≥40ml\u002Fmin\n    * Total bilirubin ≤ 1.5 mg\u002FdL, except in patients with Gilbert's Syndrome, who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    * INR \\\u003C 1.5\n\nExclusion Criteria:\n\n1. Women of child-bearing potential who are pregnant or breastfeeding.\n2. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).\n3. Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses\n4. Concurrent systemic steroid therapy, not including replacement therapy or treatment with prednisone up to 10mg daily or its equivalent. Or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention.\n5. History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n6. Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months.\n7. Subjects unable to maintain normal oxygen saturation level in room air.\n8. Subjects who have had a venous thromboembolic event requiring anticoagulation and who meet any of the following criteria:\n\n   * Have been on a stable dose of anticoagulation for \\\u003C 1 month (except for acute line insertion induced thrombosis).\n   * Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days or are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).\n9. Has a known additional malignancy within the last 3 years. Exceptions include early stage cancers (carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy).\n10. LVEF ≤ 40%\n11. Documented FEV1 ≤ 60% predicted tested in patients with:\n\n    * A prolonged history of cigarette smoking (≥ 20 pack-year smoking history, with cessation within the past two years).\n    * Symptoms of respiratory dysfunction.\n12. Patients who are at the time of study initiation receiving any other investigational agents.\n13. Carcinomatosis meningitis or other brain involvement exceeding that allowed above.\n14. Has received live vaccine within 30 days before the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.","70 Years",{"count":295,"type":21},3,[79,24],"A Phase I\u002FII Dose Escalation, Safety and Efficacy Study of HBI 0201-ESO TCRT (anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes) Given by Infusion to Patients with NY-ESO-1 -Expressing Metastatic Cancers",[299,27,300,301,302,303,304,305,306],"Sarcoma, Synovial","Melanoma Stage IV","Triple Negative Breast Cancer","Metastatic Cancer","Non Small Cell Lung Cancer","Bladder Urothelial Carcinoma","Neuroblastoma, Metastatic","Ovary Cancer",[308,309,310,311],"NY-ESO-1","TCR","adoptive transfer","retroviral transduction","2025-09-29",{"date":314,"type":37},"2025-10-02",{"date":316,"type":37},"2022-04-01",{"date":318,"type":21},"2027-12-30",{"name":320,"class":44},"Hadassah Medical Organization",{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":329,"maxAge":330,"enrollmentInfo":331,"targetDuration":4,"studyType":22,"phases":333,"briefSummary":334,"conditions":335,"keywords":341,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":45},"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":332,"type":21},60,[79,24],"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.",[83,336,337,27,338,299,339,340,196],"Sarcoma, Kaposi","Sarcoma, Ewing","Sarcoma of Bone and Connective Tissue","Sarcoma Metastatic","Sarcomas, Germinoblastic",[83,342,343,344,196],"CD146","HER2","CAR-T","2025-07-04",{"date":347,"type":37},"2025-07-15",{"date":349,"type":37},"2025-05-29",{"date":351,"type":21},"2028-12-28",{"name":353,"class":44},"Essen Biotech",{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":377},"100524843","phase-2-selinexor-plus-gemcitabine-in-selected-advanced-soft-tissue-sarcoma-selisarc-100524843","NCT06114004","Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)","Phase I\u002FII Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcomas","SeliSarc","Inclusion Criteria:\n\n1. Patients must provide written informed consent prior to performance of any study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g. imaging tests), obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.\n2. Age: 18-80 years.\n3. Histologic diagnosis of soft tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) confirmed by central pathology review prior to enrolment with an archive tumor sample. A fresh paraffin embedded tumor tissue block must be provided for all subjects for biomarker analysis before and (when feasible) after treatment with investigational products.\n4. Metastatic\u002Fadvanced disease in progression in the last 6 months.\n5. Patients have previously received at least one previous line of systemic therapy.\n6. Measurable disease according to RECIST 1.1 criteria.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n8. Adequate hepatic, renal, cardiac, and hematologic function.\n9. Laboratory tests as follows:\n\n   * Absolute neutrophil count ≥ 1,500\u002Fmm³\n   * Platelet count ≥ 100,000\u002Fmm³\n   * Bilirubin ≤ 1.5 mg\u002FdL\n   * AST and ALT ≤ 2.5 times upper limit of normal\n   * Creatinine ≤ 1.5 mg\u002FdL 10. Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan.\n\n11\\. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and agree to use birth control measures during study treatment and for 3 months after its completion. Patients must not be pregnant or nursing at study entry. Women\u002Fmen of reproductive potential must have agreed to use an effective contraceptive method.\n\nExclusion Criteria:\n\n1. Three or more systemic treatment lines (including both chemotherapy and targeted therapy) for advanced disease (localized unresectable or metastatic).\n2. Patients who have received any other anti-cancer therapy or investigational product in the last 21 days prior to enrollment.\n3. Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, adequately treated cervical carcinoma in situ, superficial bladder carcinoma) during the 5 years prior to randomization. Cancer treated with curative intent for \\>5 years previously and without evidence of recurrence will be allowed.\n4. Prior selinexor or another XPO1 inhibitor treatment.\n5. Administration of a previous gemcitabine-containing treatment.\n6. Any concurrent medical condition or disease (e.g. uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.\n7. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.\n8. Pregnant or breastfeeding females.\n9. Body surface area (BSA) \\\u003C1.4 m2 at baseline, calculated by the Du Bois(25) or Mosteller(26) method.\n10. Life expectancy of less than 3 months.\n11. Major surgery within 4 weeks prior to C1D1.\n12. Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or dysfunction that could interfere with absorption of study treatment.\n13. Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the NCCN CPGO for antiemesis and anorexia\u002Fcachexia (palliative care).\n14. Any active, serious psychiatric, medical, or other conditions\u002Fsituations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent. 15. Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)\n15. Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)","80 Years",{"count":364,"type":21},88,[24],"Phase I-II, non-randomized, single-arm, open-label, multicenter, international clinical trial.\n\nPatients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.",[27],"2025-06-24",{"date":370,"type":37},"2025-06-25",{"date":372,"type":37},"2023-09-28",{"date":374,"type":21},"2026-05-31",{"name":376,"class":44},"Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas",11,{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":392,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":45},"100507947","phase-2-brachytherapy-iodine-125-seeds-and-fluzoparib-combination-therapy-for-advanced-unresectable-soft-tissue-sarcoma-100507947","NCT05894018","Brachytherapy (Iodine-125 Seeds) and Fluzoparib Combination Therapy for Advanced Unresectable Soft Tissue Sarcoma","A Phase II Clinical Trial Evaluating the Safety and Efficacy of Radioactive Particle and Fluzoparib Combination Therapy in the Treatment of Advanced Unresectable Soft Tissue Sarcoma","RAFAS-001","Inclusion Criteria:\n\n1. Voluntarily agree to participate in this study and sign an informed consent form;\n2. Age ≥18 (calculated on the day of signing the informed consent), regardless of gender;\n3. Pathologically confirmed soft tissue sarcoma, with at least one measurable lesion according to RECIST 1.1 criteria on CT or MRI scan, within 28 days before the first study treatment (the longest diameter of the lesion ≥10 mm or the short diameter of swollen lymph node ≥15 mm);\n4. A single lesion ≤5cm and no more than 5 lesions;\n5. Received systemic therapy (such as standard treatment: doxorubicin plus ifosfamide) ± surgical resection as the first-line treatment;\n6. Able to swallow pills normally;\n7. ECOG performance status of 0-1;\n8. Expected survival period ≥12 weeks;\n9. Normal function of important organs, including:\n\nAbsolute neutrophil count ≥1.5×109\u002FL;Platelets ≥80×109\u002FL;Hemoglobin ≥90 g\u002FL;Serum albumin ≥28 g\u002FL;Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously, and if FT3 and FT4 levels are normal, patients can be included);Bilirubin ≤1.5×ULN (within 7 days before the first treatment);ALT and AST ≤3×ULN (within 7 days before the first treatment);Alkaline phosphatase (AKP) ≤2.5×ULN;Serum creatinine ≤1.5×ULN; Non-surgically sterilized or fertile female patients need to use a medically recognized contraceptive measure (such as an intrauterine device, birth control pills, or condoms) during the study treatment period and within 3 months after the end of the study treatment. Fertile female patients who are not surgically sterilized must have a negative serum or urine HCG test within 72 hours before study enrollment and must not be breastfeeding. Male patients with fertile female partners should also use effective contraception during the trial period and for 3 months after the last dose of the study treatment.\n\nExclusion Criteria:\n\n1. Clinical cardiac symptoms or disease that were not well controlled, such as: NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, QTc\\>450ms (men); QTc\\>470ms (women);\n2. Coagulation abnormal function (INR\\>2.0, PT\\>16s), bleeding tendency or on thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin, low-molecular heparin allowed;\n3. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as daily cough\u002Fhemoptysis of 2.5 ml or more, gastrointestinal bleeding, esophagogastric fundic varices with bleeding risk ;\n4. Arterial\u002Fvenous thrombotic events such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, and cerebrovascular disease) that occurred within 6 months prior to enrollment. ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;\n5. Known hereditary or acquired bleeding and thrombotic predisposition (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, etc.);\n6. Patients who have received prior chemotherapy, surgery, less than 4 weeks after completion of treatment (last dose) and prior to study dosing; or patients who have not recovered from adverse events (other than alopecia) caused by prior treatment to ≤ CTCAE grade 1;\n7. Patients with active infection, unexplained fever ≥38.5°C within 7 days prior to dosing, or white blood cell count \\>15×109\u002FL at baseline;\n8. Patients with other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) within the previous 3 years or concurrently;\n9. Patients with established bone metastases who have received, within 4 weeks prior to enrollment in the study;\n10. Prior external radiotherapy to the lesion;\n11. Pregnant or breastfeeding women, or women of childbearing age who do not wish to use contraception;\n12. Patients who, in the judgment of the investigator, have other factors that may affect the outcome of the study or force the termination of the study, such as alcoholism, substance abuse, other serious illnesses (including mental illness) requiring comorbid treatment, severe abnormal laboratory tests, accompanied by family or social factors that would affect the safety of the patient.",{"count":273,"type":21},[24],"To evaluate the effectiveness and safety of radioactive particles in combination with the PARP inhibitor fluzoparib in the treatment of advanced inoperable soft tissue sarcoma.",[27,390,391],"Brachytherapy","Poly(ADP-ribose) Polymerase Inhibitors",[393,394,395],"Fluzoparib","Radioactive particles","Iodine-125 seed","2025-05-12",{"date":398,"type":37},"2025-05-13",{"date":400,"type":37},"2023-06-29",{"date":402,"type":21},"2028-12-31",{"name":404,"class":44},"Fujun Zhang",{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":434},"100553000","phase-3-high-versus-lower-intensity-surveillance-following-resection-of-retroperitoneal-sarcoma-100553000","NCT06480396","High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma","An International, Partially-randomised, Patient-preference Trial Within a Registry of High Versus Lower Intensity Radiological Surveillance Following Primary Resection of Retroperitoneal, Abdominal and Pelvic Soft Tissue Sarcoma","SARveillance","Inclusion Criteria:\n\n* Adult patients (greater than 18 years)\n* Primary resection\n* Histologically confirmed retroperitoneal, abdominal or pelvic soft tissue sarcoma\n* R0\u002FR1 resection\n* Eligible whether or not the participant undergoes neoadjuvant treatment\n\nExclusion Criteria:\n\n* Metastatic disease at time of randomisation\n* Recurrent, metastatic or residual disease identified on baseline CT imaging (3-4 months post primary resection)\n* Reoperation for recurrent soft tissue sarcoma\n* Re-resection following previous inadequate surgery\n* R2 resection\n* Patients receiving adjuvant therapy that will delay, interrupt or render radiological surveillance unpredictable\n* Uterine sarcomas, gastrointestinal stromal tumour (GIST), fibromatosis, epithelial tumours, multifocal disease, sarcomas of bony origin\n* Patient declined to consent to data sharing with RESAR (unless in a centre contributing via pre-planned IPDMA)",{"count":414,"type":21},584,[416],"PHASE3","The SARveillance trial is an efficient, pragmatic, multi-centre, international, stratified, partially-randomised, patient-preference trial within a registry of high versus lower intensity radiological surveillance following primary resection of retroperitoneal, abdominal and pelvic soft tissue sarcoma. The trial design is stratified by sarcoma tumour grade (high\u002Fintermediate grade and low grade).",[27,419],"Sarcoma Retroperitoneal",[421,422,423,424,425],"Surveillance","Radiology","Surgery","Quality of life","Cost-effectiveness","2024-10-14",{"date":428,"type":37},"2024-10-16",{"date":430,"type":21},"2024-11",{"date":432,"type":21},"2033-12",{"name":131,"class":44},2,{"id":436,"slug":437,"hasResults":11,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":45},"100565040","phase-2-phase-ii-clinical-trial-of-chidamide-combined-with-ak112-for-second-line-and-advanced-bone-and-soft-tissue-sarcoma-100565040","NCT06637007","Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma","Single Arm, Open Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma","Inclusion Criteria:\n\n* The patient voluntarily participated in this study and signed an informed consent form；\n* All advanced bone and soft tissue sarcomas diagnosed by pathology have at least one measurable lesion according to RECIST 1.1 criteria, mainly including synovial sarcoma, smooth muscle sarcoma, vascular sarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, protuberant skin fibrosarcoma, Ewing's sarcoma\u002Fprimary neuroectodermal tumor, connective tissue proliferative small round cell tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroadenoma, chondrosarcoma, osteosarcoma. Except for the following types: malignant mesothelioma, acinar soft tissue sarcoma, gastrointestinal stromal tumor, and extra bone mucinous chondrosarcoma;\n* Patients with advanced bone and soft tissue sarcoma who experience disease progression or failure after first-line standard treatment;\n* 18\\~75 years old; ECOG PS score: 0-1 points; Expected survival period exceeding 3 months;\n* Adequate organ and bone marrow function, no severe hematopoietic dysfunction, heart, lung, liver, kidney, thyroid dysfunction, or immunodeficiency (no blood transfusion, granulocyte colony-stimulating factor, or other related medical support received within 14 days prior to the use of the study drug)；\n* The main organ function meets the following criteria within 7 days before treatment:\n\n  1. Blood routine examination standard (without blood transfusion within 14 days)：\n\n     * hemoglobin（HB）≥90g\u002FL；\n\n       * Absolute Neutrophil Count（ANC）≥1.5×109\u002FL；\n\n         * platelet（PLT）≥80×109\u002FL。\n  2. Biochemical tests must meet the following standards：\n\n     * total bilirubin（TBIL）≤1.5 upper limit of normal (ULN) ；\n\n       * Alanineaminotransferase（ALT）and Aspartic transaminaseAST≤2.5 ULN，If accompanied by liver metastasis, ALT and AST≤5 ULN；\n\n         * Serum creatinine（SCr）≤1.5 ULN or Creatinine clearance rate(CCr)≥60ml\u002Fmin；\n  3. Doppler ultrasound evaluation：Left ventricular ejection fraction (LVEF) ≥ Low limit of normal (50%)。\n* Thyroid Stimulating Hormone（TSH）or Free Thyroxine（FT4）or Free triiodothyronine（FT3）all within the normal range of ± 10%.\n* Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study period and within 6 months after the end of the study; Serum or urine pregnancy test negative within 7 days prior to enrollment in the study, and must be non lactating.\n* patient; Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.\n\nExclusion criteria: Patients with any of the following conditions will not be included in this study\n\n* Patients who have previously used sildenafil or other histone deacetylase inhibitors;\n* Previously received treatment with immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.);\n* Other malignant tumors that have occurred or are currently present within the past 5 years, except for cured cervical carcinoma in situ, non melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\\];\n* Received systemic anti-tumor therapy, including chemotherapy, immunotherapy, and biological therapy (such as tumor vaccines, cytokines, or growth factors that control cancer), within 28 days before starting the research treatment;\n* Have received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 7 days before starting the research treatment;\n* Planned systemic anti-tumor therapy within 4 weeks prior to enrollment or during the study medication period, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use of mitomycin C within 6 weeks prior to receiving experimental drug treatment). Expanded field radiation therapy (EF-RT) was performed within 4 weeks prior to enrollment, or limited field radiation therapy was performed within 2 weeks prior to grouping to assess tumor lesions;\n* Accompanied by pleural effusion or ascites, causing respiratory syndrome (≥ CTC AE grade 2 respiratory distress \\[grade 2 respiratory distress refers to shortness of breath during light activity; affects instrumental daily activities\\]);\n* Unrelieved toxic reactions above CTC AE (4.01) grade 1 caused by any previous treatment, excluding hair loss;\n* Patients with brain metastases accompanied by symptoms or symptom control time less than 2 months;\n* Patients with any severe and\u002For uncontrolled illnesses, including:\n\n  1. Patients with poor blood pressure control (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);\n  2. Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTC ≥ 480ms), and grade ≥ 2 congestive heart failure (NYHA classification);\n  3. Active or uncontrolled severe infections (≥ CTC AE level 2 infection);\n  4. Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy;\n  5. Renal failure requires hemodialysis or peritoneal dialysis;\n  6. Individuals with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n  7. Poor control of diabetes (FBG\\>10mmol\u002FL);\n  8. Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\\>1.0 g;\n  9. Patients with epileptic seizures who require treatment;\n* Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to enrollment;\n* Patients with any signs or medical history of bleeding, regardless of the severity; Patients who have experienced any bleeding or bleeding events ≥ CTCAE grade 3 within the first 4 weeks of enrollment, with unhealed wounds, ulcers, or fractures;\n* Individuals who have experienced arterial\u002Fvenous thrombotic events within the past 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism;\n* Patients with active ulcers, intestinal perforation, and intestinal obstruction;\n* Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;\n* Participated in clinical trials of other anti-tumor drugs within 28 days prior to enrollment;\n* According to the researchers' judgment, there are accompanying diseases that seriously endanger patient safety or affect the completion of the study.","75 Years",{"count":20,"type":21},[24],"Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above.",[27,83,196],"2024-10-10",{"date":449,"type":37},"2024-10-15",{"date":451,"type":37},"2024-08-01",{"date":453,"type":21},"2024-12-31",{"name":455,"class":44},"Shanxi Province Cancer Hospital",{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":17,"minAge":193,"maxAge":293,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":45},"100521830","phase-2-parp-inhibition-stereotactic-body-radiotherapy-and-immunotherapy-for-metastatic-or-advanced-sarcoma-prima-100521830","NCT06074692","PARP Inhibition, Stereotactic Body Radiotherapy and Immunotherapy for Metastatic or Advanced Sarcoma (PRIMA)","A Prospective Phase II Study of PARP Inhibition and Check Point-inhibition Immunotherapy With Concurrent Stereotactic Body Radiotherapy (SBRT) in Patients With Metastatic or Advanced Sarcoma","PRIMA","Inclusion Criteria:\n\n1. Written informed consent signed before any trial-related procedures are carried out\n2. Histologically confirmed high-grade sarcoma of bone or soft tissue; the lesion has distant metastasis or is locally advanced and cannot be completely resected at the time of enrollment, or the patient cannot tolerate or refuses surgical resection;\n3. Have received at least one systemic treatment regimen(s) at the time of enrollment, and have not received prior PARP inhibitor treatment.\n4. With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST1.1);\n5. Aged no less than 10 years old and no more than 70 years old;\n6. For patients ≥16 years old, ECOG score is between 0 and 2 (for patients with amputations, if they can basically take care of themselves and can move freely for more than 50% of their waking hours with the assistance of stretchers, walkers, wheelchairs, etc.) still included);\n7. For patients under 16 years old, Lansky score is at least 70 or above (for patients with amputations who are unable to participate in active recreational activities due to amputation), if they can participate in most active recreational activities with the assistance of walkers, wheelchairs, etc., they are still eligible included).\n8. The expected survival time is greater than 24 weeks;\n9. The majority of the recurrent lesions with an established radiological diagnosis could receive SBRT;\n10. Major organ functions meet basic safety standards within 7-14 days before treatment.\n11. Women of childbearing age should agree that they must use contraceptive measures (such as intrauterine devices, birth control pills or condoms) during the study and within 6 months after the end of the study; if in doubt, serum or urine tests within 7 days before study enrollment The pregnancy test is negative and the patient must be non-lactating; the male should agree that contraceptive measures must be used during the study period and within 6 months after the end of the study period;\n12. If there are recurrent lesions previously treated by surgery, radiofrequency ablation or radiotherapy:\n\n    1. If the image of the metastatic lesion is stable, enrollment is allowed and SBRT is not required for that lesion;\n    2. If the metastatic lesion has image progression, if it was previously treated with surgery and SBRT can be performed, enrollment is allowed; if it was previously treated with radiofrequency ablation or radiotherapy, if repeat SBRT can be considered, enrollment is allowed.\n\nExclusion Criteria:\n\n1. Diagnosed with malignant diseases other than tumors within 5 years before the first dose;\n2. Currently participating in interventional clinical research treatment, or have received other research drugs or used research equipment within 4 weeks before the first dose;\n3. Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs targeting another stimulating or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137) drug and secondary resistance to the drug (i.e., the best efficacy evaluation is CR, PR or SD lasting more than 4 months, but secondary tumor resistance develops after treatment).\n4. Received systemic systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except local use to control pleural effusion) within 2 weeks before the first dose;\n5. Active autoimmune disease requiring systemic treatment (such as use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;\n6. Are receiving systemic glucocorticoid treatment (excluding nasal spray, inhaled or other route of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study;\n7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n8. Known to be allergic to any components of monoclonal antibody preparations (have experienced grade 3 or above allergic reactions);\n9. Have not fully recovered from toxicity and\u002For complications caused by any intervention before initiating treatment (i.e., ≤Grade 1 or reaching baseline, excluding fatigue or alopecia);\n10. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV1\u002F2 antibody positive);\n11. Get live vaccine within 30 days before the first dose (cycle 1, day 1);\n12. Pregnant or lactating women;\n13. Any serious or uncontrollable systemic disease",{"count":465,"type":21},86,[24],"The aim of this study is to evaluate the efficacy and safety of PARP Inhibition and programmed cell death protein-1 (PD-1) blockade immunotherapy with concurrent stereotactic body radiotherapy (SBRT) for metastatic or advanced bone and soft tissue sarcoma.",[83,27,196],[90,470,471,472,473],"bone and soft tissue sarcoma","PARP inhibitor","SBRT","checkpoint inhibitor","2023-10-29",{"date":476,"type":37},"2023-10-31",{"date":478,"type":37},"2023-06-01",{"date":480,"type":21},"2026-12-30",{"name":482,"class":44},"Ruijin Hospital",{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":490,"phases":4,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":494,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":498,"locationsCount":4},"100486293","catequentinib-in-patients-who-have-completed-an-advenchen-study-a-compassionate-use-trial-100486293","NCT05612191","Catequentinib in Patients Who Have Completed an Advenchen Study (A Compassionate Use Trial)","An Open Label Post-Trial Access (PTA) of Catequentinib (AL3818, Anlotinib) Hydrochloride Mono or in Combination Therapies in Patients Who Have Completed an Advenchen Sponsored Oncology Study With AL3818 (A Compassionate Use Trial)","Inclusion Criteria:\n\n* Patients must be currently receiving treatment with AL3818 on a previously approved parent protocol, including drug crossover patients.\n* Patients must have achieved stable disease, partial response or complete response based on the most recent tumor assessment. If progressive disease on the most recent tumor assessment, the Investigator believes the patient can clinically benefit from continuing to receive AL3818.\n* Female patients of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception throughout the study period and for 4 months after the last dose of either study drug.\n* Patient is willing and able to sign a new informed consent.\n* Patients for whom the Investigator believes can benefit from continuing to receive AL3818\n\nExclusion Criteria:\n\n* Patient has been discontinued from their previous AL3818 trial treatment greater than 3 weeks (one cycle) prior to entering the compassionate use trial.\n* Patient progressed while receiving therapy with AL3818 during their participation in their immediate previous trial unless the Investigator believes the patient can clinically benefit from continuing to receive AL3818.","EXPANDED_ACCESS","Catequentinib (AL3818, Anlotinib) has been developed in a variety of clinical studies as single agents or in combination with others. This trial is designed to offer patients who completed an Advenchen sponsored AL3818 related study without progression the opportunity to continue to receive this investigational product in this Post-Trial Access study (a compassionate use trial), if the Investigator believes the patients can benefit from such a treatment and the patients have signed the Informed Consent Form.",[27,493],"Gynecologic Cancer","AVAILABLE","2022-11-22",{"date":497,"type":37},"2022-11-28",{"name":499,"class":500},"Advenchen Laboratories, LLC","INDUSTRY",{"id":502,"slug":503,"hasResults":11,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":508,"targetDuration":510,"studyType":113,"phases":4,"briefSummary":511,"conditions":512,"keywords":515,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":45},"100486461","endoscopic-surgery-in-the-treatment-of-soft-tissue-sarcoma-in-nasal-and-paranasal-sinus-100486461","NCT05614375","Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus","Prospective Observational Single Arm Study of Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus","Inclusion Criteria:\n\n1. Sign the informed consent form;\n2. STS of nasal cavity and paranasal sinuses diagnosed pathologically;\n3. General physical condition can tolerate endoscopic sinus surgery;\n4. There is no distant transfer;\n5. The research team must believe that the patient can be completely removed by surgery;\n6. Good organ function;\n\nExclusion Criteria:\n\n1. The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction;\n2. Suffer from uncontrolled concurrent diseases;\n3. There is a serious neurological or mental illness, including dementia and epileptic seizures;\n4. Uncontrolled active infection;\n5. There are any other circumstances that may hinder the compliance of the research;\n6. Women who are pregnant or breastfeeding.",{"count":509,"type":21},40,"5 Years","Soft tissue sarcoma (STS) refers to a group of malignant tumors derived from non-epithelial extraosseous tissues, mainly from the mesoderm, partly from the neuroectoderm, including muscle, fat, fibrous tissue, blood vessels and peripheral nerves . STS is divided into 12 major categories based on tissue origin. According to different morphologies and biological behaviors, there are more than 50 subtypes. The most common subtypes include: undifferentiated pleomorphic sarcoma (UPS), liposarcoma (LPS), leiomyosarcoma (LMS), synovial sarcoma ( SS). The most common soft tissue sarcoma in children and adolescents is rhabdomyosarcoma (RMS). Soft tissue sarcoma is a group of highly heterogeneous tumors, which are characterized by local invasiveness, invasive or destructive growth, local recurrence and distant metastasis.\n\nThe pathological features of STS that occur in the nasal cavity and sinuses are similar to other parts of the body. However, because it can affect important structures such as the orbit, optic nerve, skull base bone, dura mater, cranial nerve and even brain tissue, the diseased site is deep, the anatomical structure is complex, the treatment is difficult, the range of surgical resection is limited, and the surgical margin Negative is difficult to guarantee, and related treatments may have obvious complications, which affect the survival and prognosis of patients.\n\nSurgical treatment is the most important and most likely effective treatment for STS. With the development of endoscopic skull base anatomy and surgical techniques, the safety and effectiveness of endoscopic sinus surgery for the treatment of nasal cavity and sinus tumors have been fully confirmed, and it has become the main surgical method for nasal cavity and sinus STS. This is also the theoretical and practical basis for the feasibility of this research.\n\nThe study intends to conduct a single-arm, prospective, observational study of endoscopic sinus surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses to explore the therapeutic effect and complications of endoscopic surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses, and explore its relationship with chemotherapy and radiotherapy. The model of comprehensive treatment between.",[27,513,514,423],"Nasal Cavity Cancer","Paranasal Sinus Cancer",[86,516,517,518,519,520,521],"nasal cavity and paranasal sinus","endoscopic surgery","prognose","overall survival rate","outcome","quality of life","2022-11-07",{"date":524,"type":37},"2022-11-14",{"date":526,"type":37},"2021-06-12",{"date":528,"type":21},"2026-06-12",{"name":530,"class":44},"Eye & ENT Hospital of Fudan University"]