[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-soft-tissue-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-soft-tissue-sarcoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,44,71,100,131,161,188,214,243,270,293,316,337],{"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":14,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100591531","phase-2-pegylated-liposomal-doxorubicin-pld-versus-active-surveillance-for-advanced-soft-tissue-sarcoma-patients-who-had-controlled-disease-after-standard-anthracycline-based-treatment-melody-100591531",false,"NCT06981637","Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)","Maintenance Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)","MELODY","Inclusion Criteria:\n\n1. A histologically confirmed advanced soft tissue sarcoma. Note that subtypes typically do not use chemotherapy as standard treatment are not allowed, such as alveolar soft part sarcoma, solitary fibrous tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma)\n2. Patients received first-line anthracycline-based treatment for a minimum of 4 cycles and a maximum of 8 cycles.\n3. The best response after first-line anthracycline-based treatment must be either a complete response, partial response, or stable disease as defined by RECIST 1.1.\n\n   The best response should be attributed solely to systemic treatment and not to local therapy. All the patients must have at least one measurable tumor based on RECIST 1.1 before initiating first-line anthracycline-based treatment.\n4. Patients must be randomized within 8 weeks of their last dose of anthracycline-based treatment\n5. Patients have a life expectancy ≥ 3 months\n6. Patients older than 18 years old.\n7. ECOG performance status of 0 to 1.\n8. Patients must have adequate organ function and marrow reserve measured within 7 days prior to randomization as defined below:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL;\n   2. Absolute neutrophil count ≥ 1,500\u002Fmm3;\n   3. Platelets ≥ 100,000\u002Fmm3;\n   4. Total bilirubin ≤ 1.5 x upper normal limit;\n   5. AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x upper normal limit; for patients with liver metastases AST(SGOT)\u002FALT(SGPT) ≤ 5 x upper normal limit is allowed;\n   6. Serum creatinine ≤ 1.5mg\u002FdL or creatinine clearance ≥50ml\u002Fmin;\n   7. All women of childbearing potential must have a negative pregnancy test obtained within 72 hours before starting therapy.\n9. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.\n10. Patients with reproductive potential must use effective contraception (hormone orbarrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the completion of therapy.\n11. Patients must be able to comply with study procedures and sign informed consent.\n\nExclusion Criteria:\n\n1. Known allergy history to PLD or other drugs of liposome-based formulation.\n2. LVEF \\\u003C 50% at screening as determined by UCG or MUGA.\n3. Serious non-healing wound, ulcer, or bone fracture not related to underlying sarcoma.\n4. Major surgical procedure, open biopsy, significant traumatic injury, or radiotherapy within 21 days prior to randomization.\n5. Severe, uncontrolled medical conditions including severe liver disease, heart disease, uncontrolled diabetes or hypertension, or pulmonary disease.\n6. Psychiatric illness or social situation that would preclude study compliance.\n7. Women with pregnant or breast feeding (a urine pregnancy test must be performed on all female patients who are of childbearing potential before entering the study, and the result must be negative.\n8. Another previous malignancy diagnosed within the past 3 years. Patients with carcinoma in situ and stage I malignancy under active surveillance (no medical treatment needed) are allowed for enrollment.\n9. Active CNS metastasis defined by clinical symptoms, cerebral edema, steroid or anti- convulsant requirement, or progressive growth. Patients with a history of CNS metastasis or cord compression are allowed in the study if they have been treated and are clinically stable.\n10. Patients with active hepatitis B. However, patients with controlled hepatitis B under anti-viral agent are allowed.","ALL","18 Years",{"count":20,"type":21},81,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2",[26],"Advanced Soft Tissue Sarcoma",[28,29,30],"advanced soft tissue sarcoma","pegylated liposomal doxorubicin","open label randomized","RECRUITING","2026-07-01",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2025-12-31",{"date":39,"type":21},"2029-07-31",{"name":41,"class":42},"National Health Research Institutes, Taiwan","OTHER",7,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":5},"100464881","phase-2-testing-atezolizumab-with-selinexor-in-people--12-years-old-with-alveolar-soft-part-sarcoma-the-axiom-trial-100464881","NCT05333458","Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial","A Phase 2 Study of Atezolizumab With Selinexor in Alveolar Soft Part Sarcoma (AXIOM)","Inclusion Criteria:\n\n* To be enrolled in the safety run-in, patients must have an advanced soft tissue sarcoma (not otherwise specified \\[NOS\\]). To be enrolled in the ASPS cohort, patients must have histologically or cytologically confirmed alveolar soft part sarcoma that is not curable by surgery\n\n  * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam.\n* Patients with unresectable, metastatic and measurable ASPS that is resistant\u002Frefractory to ICI treatment will be eligible for the ASPS cohort of this study if they show clinical and\u002For radiological evidence of disease progression after receiving prior ICI therapy (including history and increasing physical symptoms). On-study documentation will include a physician's rationale that supports evidence of clinical disease progression (i.e., increasing tumor pain)\n* Age \\>= 12 years. Because no dosing or adverse event data are currently available on the use of atezolizumab in combination with selinexor in patients ˂ 18 years of age, children \\\u003C 12 years of age are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 70%)\n* Absolute neutrophil count \\>= 1,000\u002FmcL\n* Platelets \\>= 100,000\u002FmcL\n* Hemoglobin \\>= 9 g\u002FdL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =\\\u003C 3 x ULN may be enrolled)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN or =\\\u003C 5 x ULN for patients with liver metastases\n* Serum creatinine =\\\u003C 1.5 x institutional ULN OR creatinine clearance \\>= 30 mL\u002Fmin\u002F1.73 m\\^2 by Cockcroft-Gault\n* Serum albumin \\>= 2.5 g\u002FdL\n* Baseline sodium (Na+) \\>= 130 mEq\u002FL\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 28 days are eligible for this trial\n* Administration of selinexor or atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Female patients of child-bearing potential and male patients must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, for 90 days after the last dose of selinexor, and for 150 days after the last dose of atezolizumab, whichever is longer. Breastfeeding is not allowed while on selinexor or for 90 days after the last dose of selinexor. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Ability to understand and the willingness to sign a written informed consent document\n* Willingness to provide biopsy samples for research purposes, except patients enrolled on the safety run-in. Patients that cannot be safely biopsied may be considered for the study upon discussion with principal investigator\n* Ability and willingness to swallow pills\n* Vaccines intended to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease 2019 (COVID-19) are allowed\n\nExclusion Criteria:\n\n* Malabsorption syndrome or other conditions that would interfere with intestinal absorption\n* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. However, the following therapies are allowed:\n\n  * Hormone-replacement therapy or oral contraceptives\n  * Herbal therapy \\> 1 week prior to cycle 1, day 1 (herbal therapy intended as anti-cancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\n  * Palliative radiotherapy for bone metastases \\> 2 weeks prior to cycle 1, day 1\n* Treatment with any other agent administered for the treatment of the patient's cancer, within five half-lives or 3 weeks prior to cycle 1, day 1, whichever is shorter\n* History of malignancy other than ASPS prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival \\[OS\\] rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[anti-TNF\\] agents) within 2 weeks prior to cycle 1, day 1 or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Patients who have received acute, low dose, systemic immunosuppressant medications or one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible after Principal Investigator confirmation has been obtained\n  * Patients who have received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenocortical insufficiency are eligible\n* Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed\n* Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:\n\n  * Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:\n\n    * Evaluable or measurable disease outside the CNS\n    * No metastases to brain stem, midbrain, pons, medulla, or cerebellum\n    * No history of intracranial hemorrhage or spinal cord hemorrhage\n    * No ongoing requirement for dexamethasone for CNS; patients on a stable dose of anticonvulsants are permitted.\n    * No neurosurgical resection or brain biopsy within 28 days prior to cycle 1, day 1\n  * Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:\n\n    * Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and radiographic screening for the current study\n    * No stereotactic radiation or whole-brain radiation within 28 days prior to cycle 1, day 1\n    * Screening CNS radiographic study \\>= 4 weeks from completion of radiotherapy and \\>= 2 weeks from discontinuation of corticosteroids\n* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric antibodies, fusion proteins, or Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to atezolizumab or selinexor\n* Patients with uncontrolled intercurrent illness, prior malignancy, any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n* Patients who are pregnant or breastfeeding, or are expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 5 months after the last dose of atezolizumab or 3 months after the last dose of selinexor, whichever is longer. A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test (e.g., within 8 days) prior to treatment will be excluded from the study. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Women of childbearing potential must have a negative urine pregnancy test result within 8 days prior to initiation of study treatment. Pregnant women are excluded from this study because atezolizumab is a monoclonal antibody agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding should be discontinued if the mother is treated with atezolizumab. These potential risks may also apply to selinexor. Due to the potential risks, WOCBPs and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 5 months after completion of atezolizumab administration or 3 months after completion of selinexor administration, whichever is longer. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation\n* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\n\n  * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive anti-HBc \\[antibody to hepatitis B core antigen\\] antibody test) are eligible. For these patients, HBsAg and anti-HBc tests must be done within 28 days prior to enrollment\n  * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). For these patients, an HCV RNA test must be done within 28 days prior to enrollment\n* History or risk of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\n  * Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided all of the following conditions are met:\n\n    * Rash must cover less than 10% of body surface area (BSA)\n    * Disease is well controlled at baseline and only requiring low potency topical steroids\n    * No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \\[PUVA\\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) within the previous 12 months\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Patients with significant cardiovascular disease (such as New York Heart Association class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina are ineligible\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional classification. To be eligible for this trial, patients should be class IIB or better\n* Patients with active tuberculosis (TB) are excluded\n* Patients with mild or moderate signs or symptoms of infection within 2 weeks prior to cycle 1, day 1 (including, but not limited to, receiving oral or intravenous \\[IV\\] antibiotics) are excluded. Patients with severe infections within 4 weeks prior to cycle 1, day 1 (including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia) are excluded. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible\n* Major surgical procedure within 28 days prior to cycle 1, day 1\n* Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab\n\n  * Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study\n* History of leptomeningeal disease\n* Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry, with no changes to their pain regimen in the 4 weeks prior to enrollment\n* Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period\n* Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n* Patients with indwelling catheters (e.g., PleurX \\[registered trademark\\]) are allowed\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n* Current treatment with anti-viral therapy for HBV\n* Treatment with investigational therapy within five half-lives or 28 days prior to initiation of study treatment, whichever is shorter","12 Years",{"count":53,"type":21},27,[24],"This phase II trial tests whether atezolizumab in combination with selinexor works to shrink tumors in patients with alveolar soft part sarcoma and whether the study drugs are better than the usual approach in treating this type of cancer. The usual approach is defined as care most people get for alveolar soft part sarcoma if they are not part of a clinical study, which includes treatment with radiation, kinase inhibitor drugs, immunotherapy drugs, or chemotherapy drugs. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by blocking a protein called CRM1, which may help keep cancer cells from growing and may kill them. Giving atezolizumab in combination with selinexor may help shrink tumors and stabilize the cancer in patients with alveolar soft part sarcoma.",[57,26,58,59,60],"Advanced Alveolar Soft Part Sarcoma","Metastatic Alveolar Soft Part Sarcoma","Refractory Alveolar Soft Part Sarcoma","Unresectable Alveolar Soft Part Sarcoma","2026-06-19",{"date":63,"type":35},"2026-06-23",{"date":65,"type":35},"2022-08-29",{"date":67,"type":21},"2027-05-01",{"name":69,"class":70},"National Cancer Institute (NCI)","NIH",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100554404","phase-1-testing-the-addition-of-an-anti-cancer-drug-abemaciclib-to-the-usual-chemotherapy-treatment-gemcitabine-for-soft-tissue-sarcoma-100554404","NCT06498648","Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma","Phase I\u002FII Study to Evaluate the Feasibility and Efficacy of Sequential Abemaciclib and Gemcitabine Treatment in Patients With Retinoblastoma (Rb)+ Sarcomas","Inclusion Criteria:\n\n* Phase 1: Patients must have advanced\u002Fmetastatic histologically confirmed soft tissue sarcoma and have received at least one prior standard systemic therapy (prior gemcitabine is allowed)\n* Phase 2: Patients must have advanced\u002Fmetastatic pathologically confirmed leiomyosarcoma or dedifferentiated liposarcoma for which gemcitabine and docetaxel is considered standard-of-care, patients may be systemic-treatment naïve. Prior gemcitabine is not allowed\n* Patients must have presence of measurable\u002Fassessable tumor\n* Patients must have intact Rb gene expression in the baseline tumor biopsy or archived tumor sample, as assessed by immunohistochemistry (at MD Anderson: clone G3- 245, BD Pharmagen, RRID:AB\\_385259, Clinical Laboratory Improvement Act \\[CLIA\\] certified antibody)\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of abemaciclib in combination with gemcitabine in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count ˃ 1.2K\u002FµL\n* Hemoglobin ˃ 9.0 g\u002FdL\n* Platelets ˃ 100K\u002Fmm\\^3\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN), patient with Gilbert's syndrome ≤ 2.0 times ULN, or direct bilirubin within normal limits\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) ≤ 1.5 × institutional ULN\n* Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 1.5 × institutional ULN\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\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* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification. To be eligible for this trial, patients should be class congestive heart failure (CHF) II or better\n* Patients must have a life expectancy of greater than 6 months\n* Females of childbearing potential must have a negative serum pregnancy test within one week of trial enrollment and be willing to use an adequate method of contraception to avoid pregnancy throughout the trial and for up to 6 months after the last dose of drug therapy. The effects of abemaciclib on the developing human fetus are unknown. For this reason and because CDK 4\u002F6 inhibiting agents as well as gemcitabine are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of abemaciclib administration. Abstinence is considered an effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study ranging from three weeks prior to initiation of treatment and up to 6 months after the last dose of treatment\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Patient is capable of swallowing oral medications\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents. There must be no investigational drug use within 30 days or 5 half-lives of receiving the first dose of treatment on this treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to abemaciclib or gemcitabine\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because abemaciclib is a CDK4\u002F6 inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with abemaciclib or gemcitabine, breastfeeding should be discontinued if the mother is treated with abemaciclib or gemcitabine\n* Use of strong CYP34A inhibitors which cannot be discontinued by the patient prior to trial initiation. The washout period of these drugs should be 5 half-lives\n* Progression on prior CDK4 inhibitor therapy\n* Phase 2 only: Prior gemcitabine-based chemotherapy\n* Presence of significant cardiac disease. Significant cardiac disease includes personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* Patients with interstitial lung disease (ILD)\n* Patients with gastrointestinal conditions that may affect the absorption of oral medications\n* Patients must not have received or be scheduled to receive radiation therapy within 7 days or less from gemcitabine administration\n* Patients must not have had major surgery within 14 days prior to randomization",{"count":79,"type":21},74,[81,24],"PHASE1","This phase I\u002FII trial tests the side effects and best dose of abemaciclib when added to gemcitabine and compares the effectiveness of that treatment to the usual treatment of gemcitabine with docetaxel for the treatment of patients with soft tissue sarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) (phase 1) or patients with leiomyosarcoma or dedifferentiated liposarcoma (phase 2). Abemaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic soft tissue sarcoma or leiomyosarcoma or dedifferentiated liposarcoma.",[84,85,26,86,87,88,89,90],"Advanced Dedifferentiated Liposarcoma","Advanced Leiomyosarcoma","Metastatic Dedifferentiated Liposarcoma","Metastatic Leiomyosarcoma","Metastatic Soft Tissue Sarcoma","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","2026-06-16",{"date":93,"type":35},"2026-06-17",{"date":95,"type":35},"2026-03-18",{"date":97,"type":21},"2027-01-31",{"name":69,"class":70},1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":130},"100604980","phase-1-actinium-therapy-for-late-stage-aggressive-sarcomas-100604980","NCT07156565","Actinium Therapy for Late-stage Aggressive Sarcomas","A Seamless Phase 1\u002F2 Open-label Study to Evaluate the Safety, Determine the Maximum Tolerated Dose of Administered Activity, and Evaluate the Efficacy of the Therapeutic Radiopharmaceutical [Ac 225]-RTX-2358 in the Treatment of Relapsed or Refractory Sarcoma","ATLAS","Inclusion Criteria:\n\n* 18 years of age or older.\n* History of relapse and refractory soft tissue sarcoma.\n\n  1. Histological confirmation of sarcoma at any point since diagnosis\n  2. At least 1 prior treatment regimen\n* Measurable disease as per RECIST (v1.1) for soft tissue sarcoma that is also positive on FAPi PET\u002FCT or PET\u002FMRI scan.\n* ECOG performance status of 0 or 1.\n* Adequate Organ reserve and renal function as evidenced by:\n\n  1. Neutrophil count ≥ 1200 µL without granulocyte colony stimulating factor\n  2. Platelet count ≥ 100,000 µL\n  3. Hemoglobin ≥ 8 g\u002FdL\n  4. Total bilirubin level ≤ 1.5 × upper limit of normal (ULN).\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n  6. Calculated creatinine clearance ≥ 60 mL\u002Fmin. 6. Coagulation parameters (prothrombin time, international normalized ratio and activated partial thromboplastin time) ≤ 1.5 × ULN 7. All patients (males and females of childbearing potential) must agree to practice 2 forms of highly effective contraceptive precautions to prevent pregnancy from the time consent is signed and throughout the trial.\n\n     8\\. The patient or the patient's legal representative must be willing and able to provide written informed consent.\n\n     Exclusion Criteria:\n* History of whole pelvic irradiation.\n* History of radioligand therapy.\n* Treatment within 14 days prior to first administration with:\n\n  1. Palliative surgery or external beam radiation.\n  2. Approved anticancer therapy including chemotherapy or immunotherapy.\n  3. Any investigational therapy.\n  4. Any major surgery (e.g., requiring general anesthesia).\n* Patients who are scheduled for external beam radiation therapy or radioligand therapy during the study period.\n* Congestive heart failure \\> Class II New York Heart Association Functional Classification, current pericarditis, myocardial infarction within 6 months, or symptomatic coronary artery disease.\n* Patients with uncontrollable incontinence.\n* Unstable or clinically significant concurrent medical condition that would, in the opinion of the Investigator, jeopardize the safety of a patient and\u002For their compliance with the protocol.\n* Active infection requiring systemic antibacterial\u002Fantibiotic, antifungal, or antiviral therapy. Chronic antiviral therapy for stable viral disease can be included.\n* History of active fibrotic condition.\n* Any active malignancy other than sarcoma that requires treatment.\n* Stable brain metastasis is allowed but documented untreated metastases to brain or meninges are excluded.\n* Currently pregnant or lactating.\n* Known allergy to any of the study drugs or their excipients.\n* Inability or unwillingness to comply with any of the required imaging studies or study assessments.",{"count":109,"type":21},30,[81],"The goal of this clinical trial is to learn about the safety of drug \\[Ac225\\]RTX-2358 and the diagnostic imaging agent \\[Cu64\\]LNTH-1363S. Additionally Ratio Therapeutics will learn if \\[Ac225\\]RTX-2358 drug is effective in treating advanced sarcoma.\n\nThe main questions the study aims to answer in Phase\u002FPart 1 of the trial are:\n\n* Is \\[Ac225\\]RTX-2358 tolerable or does it cause toxicities (medical problems) in patients.\n* What is the most tolerable dose of \\[Ac225\\]RTX-2358\n* Does the treatment show effectiveness on advanced sarcoma\n\nParticipants will:\n\n* Take drug \\[Ac225\\]RTX-2358 once every 8 weeks (4 cycle target; 6 cycle maximum) over a period of 12 months\n* Visit the clinic three times for the first week of cycle one, then once a week for the remaining 7 weeks of cycle 1 for check-ups and tests.\n* For cycles 2-6: patient will visit the clinic once every 2 weeks for checkups and tests\n* Remain in long term follow-up for a period of four additional years",[26],[114,115,116,117,118,119,28],"Radioligand Therapy","Sarcoma","Relapsed or refractory sarcoma","Soft tissue sarcoma","Radiopharmaceuticals","Theranostics","2026-03-13",{"date":122,"type":35},"2026-03-17",{"date":124,"type":35},"2025-11-12",{"date":126,"type":21},"2032-01",{"name":128,"class":129},"Ratio Therapeutics, Inc.","INDUSTRY",6,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":148,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100453255","phase-2-combination-of-pembrolizumab-and-cabozantinib-in-patients-with-advanced-sarcomas-100453255","NCT05182164","Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas","PEMBROCABOSARC","Inclusion Criteria:\n\n1. Histology: undifferentiated pleomorphic sarcoma (stratum 1), bone osteosarcoma (stratum 2), bone or extraskeletal or Ewing sarcoma (stratum 3),\n2. Advanced non resectable \u002F metastatic disease,\n3. Recurrent disease or progression after standard therapy,\n4. Documented progression according to RECIST criteria.\n5. Have provided tissue of a tumor lesion from \\\u003C 3 months old archival tissue sample obtained on locally advanced disease, or metastatis with no subsequent treatment since or from a newly obtained core or excisional biopsy,\n6. No more of three previous lines of systemic therapy for advanced disease,\n7. Age ≥ 18 years,\n8. Eastern Cooperative Oncology Group ≤ 1,\n9. Measurable disease according to RECIST v1.1 outside any previously irradiated field. At least one site of disease must be uni-dimensionally ≥ 10 mm,\n10. Life expectancy \\> 3 months,\n11. Participant must have advanced disease and must not be a candidate for other approved therapeutic regimen known to provide significant clinical benefit based on investigator judgement,\n12. No symptomatic central nervous system disease,\n13. No chronic use of glucocorticoids.\n14. Adequate hematological, renal, metabolic and hepatic function,\n15. No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,\n16. At least three weeks since last chemotherapy, immunotherapy and two weeks for any other pharmacological treatment and\u002For radiotherapy,\n17. Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment (excluding alopecia of any grade, non-painful peripheral neuropathy grade ≤ 2 and endocrine-related grade ≤ 2 requiring treatment or hormone replacement) (according to NCI-CTCAE, version 5.0). For patients previously treated by radiotherapy, they must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis,\n18. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication. Both women and men must agree to use 2 medically acceptable methods of contraception throughout the treatment period and for 6 months after discontinuation of treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥ 1 year,\n19. Voluntary signed and dated written informed consents prior to any specific study procedure,\n20. Patients with a social security in compliance with the French Law.\n\nExclusion Criteria:\n\n1. Previous treatment with Pembrolizumab or Cabozantinib,\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumabor any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways),\n3. Evidence of progressive or symptomatic central nervous system or leptomeningeal metastases,\n4. Men or women of childbearing potential who are not using an effective method of contraception; women who are pregnant or breast feeding, men or women who are planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment,\n5. Participation to a study involving a medical or therapeutic intervention in the last 21 days,\n6. Previous enrolment in the present study,\n7. Patient unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons,\n8. Patient unable to swallow,\n9. Known hypersensitivity to any involved study drug or of its formulation components,\n10. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy is not considered a form of systemic treatment and is allowed.\n11. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment,\n12. History of idiopathic pulmonary fibrosis, history of non-infectious pneumonitis that required steroids, current pneumonitis\u002Finterstitial lung disease, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted,\n13. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n14. Has a known history of HIV infection and\u002For of active TB (Bacillus Tuberculosis),\n15. Treatment with anticoagulants such as anti-Vitamin K, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel),\n16. Previous allogenic bone marrow transplant or solid organ transplantation,\n17. Has an active infection requiring systemic treatment at study entry,\n18. The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms within 28 days before treatment. Note: if initial QTcF is found to be \\> 500 ms, two additional ECGs separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is ≤ 500 ms, the subject meets eligibility in this regard,\n19. The subject requires chronic concomitant treatment of strong CYP3A4 inducers\n20. The subject has experienced any of the following: Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment, Hemoptysis of ≥ 2.5 mL of red blood within 3 months before the first dose of study treatment, Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment, The subject has radiographic evidence of cavitating pulmonary lesion(s), The subject has tumor in contact with, invading or encasing any major blood vessels, or The subject has evidence of tumor invading the GI tract, or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib.\n21. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions which are fully described in the study protocol: Cardiovascular disorders, Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation, Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy,\n22. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Note: 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.\n23. Has an history or current evidence of any condition, therapy, or laboratory abnormality that might counfound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n24. The subject is planning to have oral surgery\u002Finvasive dental procedure within the projected duration of the study, starting with the screening visit through 3 months after the last dose of study treatment or had such a procedure within 3 months of first dose of study treatment.",{"count":139,"type":21},119,[24],"Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.",[143,144,145,146,147],"Soft Tissue Sarcoma Adult","Advanced Soft-tissue Sarcoma","Ewing Sarcoma","Osteosarcoma","Undifferentiated Pleomorphic Sarcoma",[149,150],"soft-tissue sarcoma","immune checkpoint inhibitor","2025-10-01",{"date":153,"type":35},"2025-10-07",{"date":155,"type":35},"2022-04-25",{"date":157,"type":21},"2027-12",{"name":159,"class":42},"Institut Bergonié",10,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},"100429610","phase-2-bintrafusp-alfa-and-doxorubicin-hydrochloride-in-treating-patients-with-advanced-sarcoma-100429610","NCT04874311","Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma","Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST Study","TRUST","Inclusion Criteria:\n\n1. Histologically confirmed soft-tissue sarcoma with unknown translocation (including the following histologies but not limited to undifferentiated pleomorphic sarcomas, dedifferentiated liposaromas or leiomyosarcomas). Diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de référence en pathologie des sarcomes et des viscères) as recommended by the French NCI (Institut National du Cancer, Inca).\n2. Metastatic or unresectable locally advanced disease,\n3. No previous systemic treatment for advanced\u002Fmetastatic disease,\n4. For TLS status: available archived FFPE (Formalin-Fixed Paraffin-Embedded) tumor tissue sample or tumor material newly obtained by biopsy. Except if TLS analysis have been already performed by Biopathological platform at Bergonié Institute, presence or absence of TLS should be confirmed by central review based on FFPE tumor tissue sample (archived or newly obtained by biopsy for research purpose),\n5. Age ≥ 18 years,\n6. ECOG ≤ 1,\n7. Life expectancy \\> 3 months,\n8. Patients must have measurable disease defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension as \\> 10 mm with spiral CT scan.,\n9. Patient must comply with the collection of tumor biopsies and biomarkers study. Tumors must be accessible for biopsy,\n10. Adequate hematological, renal, metabolic and hepatic function\n11. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization. Serum or urine pregnancy test must be repeated within 72 hours prior to receiving the first dose of study medication,\n12. Both women and men must agree to use a highly effective method of contraception throughout the treatment period and for at least two months after discontinuation of treatment for women and four months for men.\n13. No prior or concurrent malignant disease diagnosed or treated in the last 3 years except for superficial\u002Fnon-invasive bladder cancer, or basal or squamous cell carcinoma in situ treated with curative intent; b. endoscopically resected GI cancers limited to the mucosal layer without recurrence in \\> 1 year,\n14. Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia and vitiligo of any grade and non-painful peripheral neuropathy grade ≤ 2) according to to NCI-CTCAE, version 5.0,\n15. Voluntarily signed and dated written informed consent prior to any study specific procedure,\n16. Patients with a social security in compliance with the French law.\n\nExclusion Criteria:\n\n1. Previous treatment with doxorubicin, daunorubicin, epirubicin, idarubicin and\u002For any other anthracyclines or anthracediones at the maximum cumulative dose or any approved or investigational treatment targeting PD1, PD-L1 or TGFB1,\n2. Known central nervous system malignancy (CNS),\n3. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding,\n4. Participation to a study involving a medical or therapeutic intervention in the last 30 days,\n5. Previous enrolment in the present study,\n6. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,\n7. Known hypersensitivity to any involved study drug or any of its formulation components,\n8. Any history of anaphylaxis, or recent, within 5 months, history of uncontrollable asthma,\n9. Individuals deprived of liberty or placed under legal guardianship,\n10. Any of the following cardiac criteria:\n\n    1. Mean resting corrected QT interval (QTcF) ≥ 470 msec, obtained from three consecutive ECGs,\n    2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG,\n    3. LVEF ≤ 50% per CTCAE v5 by MUGA or echocardiogram\n    4. Any factors increasing the risk of QTc prolongation or arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years old or any concomitant medication known to prolong the QT interval,\n    5. Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris, uncontrolled hypertension, congestive heart failure NYHA Grade ≥2, ventricular arrhythmias requiring continuous therapy, supraventricular arrhythmias including atrial fibrillation, which are uncontrolled, haemorrhagic or thrombotic stroke, including transient ischaemic attacks, cerebral vascular accident\u002Fstroke or any other central nervous system bleeding\n11. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:\n12. History of bleeding diathesis or recent major bleeding event ,\n13. Prior organ transplantation including allogenic stem-cell transplantation, except transplants that do not require immunosuppression,\n14. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection requiring systemic therapy, drug-induced interstitial lung disease or subject has had a history of drug-induced pneumonitis that has required oral or IV steroids, and\u002For other diseases, which in the opinion of the investigator might impair the subject's tolerance for the study or ability to consistently participate in study procedures,\n15. Active infection including tuberculosis ,\n16. Has known active hepatitis B or hepatitis C,\n17. Has a known history of Human Immunodeficiency Virus infection,\n18. Receipt of live attenuated vaccine within 30 days prior to the first dose of treatment. Note: Patients, if enrolled, should not receive live vaccine within 30 days prior to the first dose of treatment, whilst receiving study treatments and up to 30 days after the last dose. Seasonal flu vaccines that do not contain a live virus are permitted,\n19. Patients with current or history of deep vein thrombosis within 6 months prior to randomization,\n20. Any contraindication to biopsy for the research,\n21. Any other contraindication to Doxorubicin administration,.\n22. Patients with oral anticoagulation therapy based on Vitamin K antagonist.\n23. Prior mediastinal radiation.",{"count":170,"type":21},80,[24],"This study encompasses two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin",[144,174],"Metastatic Soft-tissue Sarcoma",[176,149,177,178],"tertiary lymphoid structure","advanced\u002Fmetastatic","immunotherapy","2025-08-11",{"date":181,"type":35},"2025-08-13",{"date":183,"type":35},"2022-03-01",{"date":185,"type":21},"2027-07",{"name":159,"class":42},8,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":99},"100544299","phase-2-a-trial-of-cadonilimab-with-adriamycin-in-patients-with-advanced-soft-tissue-sarcoma-100544299","NCT06367075","A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma","The Efficacy and Safety of Cadonilimab(AK104) With Adriamycin for First-line Treatment of Advanced Soft Tissue Sarcoma: a Multicenter, Single-arm, Phase II Clinical Trial","Inclusion Criteria:\n\n* Patients who were pathologically confirmed soft tissue sarcoma (soft tissue sarcomas other than alveolar\u002Fembryonal rhabdomyosarcoma, clear cell sarcoma, extraosseous Ewing sarcoma, alveolar soft tissue sarcoma, well differentiated liposarcoma, extraosseous myxoid chondrosarcoma, etc.)\n* The patient was diagnosed as progressive and the investigators determined that the lesion was not suitable for surgical treatment\n* The patients had not received systemic therapy (including chemotherapy, targeted therapy and bioimmunotherapy) for advanced soft tissue sarcoma. More than 6 months have passed since the end of neoadjuvant\u002Fadjuvant therapy (including chemotherapy, targeted therapy, bioimmunotherapy, etc.), and the cumulative dose of adriamycin used in the past was ≤100 mg\u002Fm2\n* In patients with measurable disease, lesions are defined and monitored by RECIST v1.1\n* Aged ≥ 18 years old, \\\u003C 60 years old\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, amputees can be 0-2\n* Expected survival \\> 3 months\n* Adequate organ and bone marrow function, defined as follows: ① Blood routine (14 days before screening without blood transfusion, without G-CSF, without drug correction): neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; platelet count (PLT) ≥ 100 × 10\\^9\u002FL; hemoglobin (Hb) ≥ 100 g\u002FL; ② Blood biochemistry: serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60ml\u002Fmin; total bilirubin (TBIL) ≤ 1.5 × ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 × ULN, The subjects with liver metastasis should be ≤ 5 × ULN; ③ Coagulation function: international normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; ④ Urinalysis: urine protein \\\u003C 2 +; if urine protein ≥ 2 +, the 24-hour urine protein quantification must be ≤ 1g; ⑤ thyroid stimulating hormone (TSH) ≤ ULN and ≥ LLN; if abnormal, T3 and T4 levels should be investigated, normal T3 and T4 levels can be included\n* Cardiac function:1) 12-lead electrocardiogram showed no severe arrhythmias, QTcF ≤ 480 ms; 2) No signs of myocardial ischemia; 3) LVEF ≥55% by cardiac ultrasound (measured by the biplane Simpson method); 4) NT-proBNP \\\u003C age cutoff value; 5) Troponin within normal values.\n* Agree and have signed informed consent, willing and able to comply with scheduled visits, study treatment, laboratory tests and other test procedures\n* Women of childbearing potential should have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study treatment; and should be willing to use one acceptable contraception (i.e., oral contraceptives, condoms, intrauterine devices \\[IUDs\\]) throughout the period of taking study treatment and for at least 3 months after the last dose of study drug(s). For men, surgical sterilization or consent to appropriate contraception during observation and up to 90 days after the last treatment should be used\n\nExclusion Criteria:\n\n* known allergy to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components\n* Known allergy to recombinant humanized anti-CTLA-4 monoclonal antibody drug and its components\n* known allergy to any component of the cadonilimab formulation\n* Patients with cardiac disease class II or higher as determined by the New York Heart Association (NYHA) score\n* Palliative radiotherapy within 2 weeks prior to the first dose\n* Other active malignancy within 5 years prior to enrollment. Except for locally curable malignancies (manifested as cured) such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, endometrial carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ\n* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study\n* Active autoimmune disease requiring systemic therapy within 2 years prior to the start of study treatment, or autoimmune disease that, in the judgment of the Investigator, is likely to recur or for which treatment is planned; except for the following: skin diseases not requiring systemic therapy (e.g., vitiligo, alopecia areata, psoriasis, or eczema); hypothyroidism due to autoimmune thyroiditis requiring only a stable dose of hormone replacement therapy; well-controlled type I diabetes mellitus; childhood well-controlled type I diabetes mellitus; subjects whose childhood asthma has completely resolved and does not require any intervention in adulthood; and subjects who, in the judgment of the investigator, have a disease that will not recur in the absence of external triggers\n* Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea) that is active or requires clinical management\n* Subjects will require systemic therapy with corticosteroids (\\>10 mg\u002Fday of prednisone equivalents) or other immunosuppressive medications within 14 days of administration of study drug. Inhaled or topical topical steroids and adrenal replacement doses \\>10 mg\u002Fday of prednisone equivalent are allowed in the absence of active autoimmune disease. Topical, ocular, intra-articular, intranasal and inhaled corticosteroids (with minimal systemic absorption) are permitted in subjects. Physiologic replacement doses of systemic corticosteroids are permitted, even if \\>10 mg\u002Fday of prednisone equivalent. Short-term use of corticosteroids is permitted for prophylaxis (e.g., contrast allergy) or for treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reactions due to contact allergens)\n* Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome\n* History of known allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n* Known presence or history of interstitial lung disease\n* Received a live vaccine within 30 days prior to the first dose of cadonilimab or plan to receive a live vaccine during the study period\n* Subjects with necrotic lesions detected on examination within 4 weeks prior to enrollment that, in the judgment of the investigator, pose a risk of major bleeding\n* Serious infection, including but not limited to concomitant complications requiring hospitalization, sepsis, or severe pneumonia, within 4 weeks prior to first dose\n* Known active tuberculosis (TB). Subjects suspected of having active TB will be examined by chest X-ray, sputum, and exclusion by clinical signs and symptoms\n* Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA \\>1000 IU\u002FmL, and patients with active hepatitis C should be excluded. Inactive hepatitis B surface antigen (HbsAg) carriers, treated and stabilized hepatitis B patients (HBV DNA \\\u003C1000 IU\u002FmL), and cured hepatitis C patients may be enrolled. For HCV Ab-positive subjects, participation in the study is eligible only if the HCV RNA test result is negative\n* Major surgical procedure within 30 days prior to the first dose of cadonilimab or have not fully recovered from a prior procedure. Localized surgical procedures (e.g., systemic port placement, core needle biopsy, and prostate biopsy) are permitted provided that the procedure is completed at least 24 hours prior to the time of the first dose of study treatment medication\n* Presence of known meningeal metastases, spinal cord compression, molluscum contagiosum disease, or active brain metastases. However, enrollment is allowed for subjects who meet the following requirements and have a measurable lesion outside the CNS: 1) previously untreated and currently asymptomatic (e.g., no neurologic deficits, seizures, or other signs and symptoms typical of CNS metastases; glucocorticoid therapy is not required); 2) asymptomatic after treatment has been imaging stable for at least 4 weeks prior to the initiation of study treatment (e.g., no new or enlarging brain metastatic lesion ) and have discontinued systemic glucocorticoid and anticonvulsant medication for at least 2 weeks\n* Subjects with pleural effusions, pericardial effusions, or ascites that, in the judgment of the Investigator, remain unstably controlled using repeated drainage or other methods\n* Uncontrolled co-morbidities, including symptomatic congestive heart failure (grade 3 or 4 as determined by the New York Heart Association functional classification), uncontrolled hypertension, unstable angina, poorly controlled cardiac arrhythmias, acute or evidence of ongoing myocardial ischemia, severe active peptic ulcer disease or gastritis, or mental illness\u002Fsocial disease that would limit the subject's ability to comply with the study requirements or interfere with the subject's ability to provide written mental illness\u002Fsocial condition that would limit the subject's ability to provide informed consent. Any arterial thromboembolic event, including myocardial infarction, cerebrovascular accident, or transient ischemic attack, history of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism within 6 months prior to enrollment\n* Unreversed toxicity from prior antineoplastic therapy, defined as toxicity that has not returned to NCI CTCAE version 5.0 grade 0 or 1, or to a level specified in the inclusion\u002Fexclusion criteria (except alopecia areata). Subjects who experience irreversible toxicity that is not expected to worsen with administration of study drug (e.g., hearing loss) may be included in the study after consultation with the Medical Ombudsman. Subjects with radiotherapy-induced long-term toxicity that, in the judgment of the Investigator, is not reversible may be included in the study after consultation with the Medical Ombudsman\n* Females who are pregnant or breastfeeding\n* Any condition that, in the opinion of the Investigator, may render treatment with the study drug risky or will interfere with the evaluation of the study drug or the safety of the subject or the resolution of the study results","75 Years",{"count":197,"type":21},53,[24],"This is a single-arm, multicenter trial of cadonilimab (AK104) with adriamycin in patients with first-line advanced soft tissue sarcoma. the primary objective is to evaluate objective response rate of cadonilimab with adriamycin.",[144],[144,202,203,204],"cadonilimab","chemotherapy","Anti-PD-1\u002FCTLA4 bispecific antibody","2025-07-14",{"date":207,"type":35},"2025-07-18",{"date":209,"type":35},"2024-10-09",{"date":211,"type":21},"2029-03-31",{"name":213,"class":42},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":17,"minAge":222,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":99},"100420636","phase-3-comparison-of-oral-cyclophosphamide-vs-doxorubicin-in-65-years-old-advanced-or-metastatic-soft-tissue-sarcoma-patients-100420636","NCT04757337","Comparison of Oral Cyclophosphamide vs Doxorubicin in ≥65 Years Old Advanced or Metastatic Soft Tissue Sarcoma Patients","Randomized Phase III Study of Oral Cyclophosphamide vs Doxorubicin in 65 Years or Older Patients With Advanced or Metastatic Soft Tissue Sarcoma: a UNICANCER\u002FGERICO Multicenter Program","GERICO14","Inclusion criteria:\n\n1. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trust person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent\n2. Age ≥65 years (inclusions will be managed to ensure that at least 50% of the randomized patients are ≥75 years old)\n3. Diagnosis of soft-tissue sarcoma histologically confirmed by Réseau de Référence en Pathologie des Sarcomes et des Viscères (RRePS)\n4. Metastatic or locally advanced disease not amenable to surgery, radiation, or combined modality treatment with curative intent. Palliative radiation therapy is permitted only if direct on nontarget lesion\n5. Documentation of disease progression within the last 6 months before randomization\n6. Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT-scan as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)\n7. Life expectancy of at least 6 months\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n9. G8 score \\>14\n10. Left ventricular ejection fraction (LVEF) value by echocardiogram or Multiple gated acquisition scanning (MUGA) ≥55%\n11. Adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:\n\n    1. Absolute neutrophil count (ANC) ≥1,500\u002Fmm³\n    2. Platelets ≥100,000\u002Fmm³\n    3. Hemoglobin ≥9.0 g\u002FdL\n    4. Serum creatinine ≤2 x upper limit of normal (ULN)\n    5. Glomerular filtration rate (GFR) ≥50 ml\u002Fmin\u002F1.73m² (calculated with MDRD)\n    6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5.0 × ULN for patients with liver involvement of their cancer )\n    7. Total bilirubin ≤1.5 X ULN\n    8. Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN with liver involvement of their cancer)\n    9. serum albumin \\>25 g\u002FL\n    10. Prothrombin time (PT)\u002FInternational normalized ratio (INR) ≤1.5 x ULN Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until PT\u002FINR is stable based on a measurement that is pre-dose as defined by the local standard of care\n12. Male patients must agree to use adequate contraception for the duration of trial participation and up to 6 months after completing treatment\u002Ftherapy. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care\n13. Patients must be affiliated to a Social Security System (or equivalent)\n14. Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures including follow-up\n\nExclusion Criteria:\n\n1. Previous systemic treatment for advance or metastatic sarcoma\n2. Previous neoadjuvant or adjuvant anthracycline treatment for localized sarcoma\n3. Soft-tissue sarcoma with the following histological subtypes: dermatofibrosarcoma protuberans, desmoid tumor, alveolar or embryonal rhabdomyosarcoma, Desmoplastic small round cell tumor, Kaposi Sarcoma, Gastro-Intestinal stromal tumor, Peripheral neuroectodermal tumors\n4. Primary bone sarcoma (including osteosarcoma, Ewing tumor, chondrosarcoma, and chordoma)\n5. Symptomatic or known central nervous system (CNS) metastases\n6. Known history of or concomitant malignancy likely to affect life expectancy in the judgment of the investigator and history of radiotherapy mediastinal in the last five years\n7. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before Day 1 of treatment\n8. Active cardio vascular disease including any of the following: Congestive heart failure (New York Heart Association (NYHA) ≥Class 2), unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), acute inflammatory cardiopathy, severe arrythmia, high risk of bleeding, cerebrovascular accident within the last 6 months\n9. Uncontrolled grade \\>2 hypertension. (Systolic blood pressure ≥160 mmHg or diastolic pressure ≥100 mmHg despite optimal medical management)\n10. Ongoing infection ≥Grade 2 according to NCI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)\n11. Known history of human immunodeficiency virus (HIV) infection\n12. Known history of chronic hepatitis B or C\n13. History of organ allograft\n14. Pre-existing acute hemorrhagic cystitis, urinary tract obstruction, acute urinary tract infection\n15. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study\n16. Substance abuse, medical condition, that may interfere with the patient's participation in the study or evaluation of the study results\n17. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation\n18. Inability to swallow oral medications, any malabsorption condition.\n19. Persons deprived of their liberty or under protective custody or guardianship\n20. Participation in another therapeutic trial within the 30 days prior to randomization and during the study\n21. Patients having received live attenuated vaccine therapy used for prevention of diseases as influenza, chickenpox, zoster, measles, mumps, rubella, tuberculosis, rotavirus or yellow fever within 4 weeks of the first dose of study drug. These vaccinations are not permitted during the study up to 6 months after the last treatment\n22. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons","65 Years",{"count":224,"type":21},214,[226],"PHASE3","Most advanced or metastatic soft tissue sarcoma (STS) are unfortunately incurable, making the preservation of the patient's quality of life a major goal, along with prolonging survival.\n\nAge is not a criterion for not providing effective treatment, but the goals of treatment change with age and must be integrated into the treatment decision. Elderly patients prioritise a life free of dependency, preservation of their cognitive functions and quality of life related to their state of health. They are therefore reluctant to receive a treatment that does little to improve life expectancy at the cost of significant functional losses.\n\nPatients aged 65 years and older account for one third of all patients with STS. In the absence of dedicated recommendations, these elderly patients are currently receiving doxorubicin-based chemotherapy as first-line treatment (as recommended for younger patients), with a substantial risk of toxicity (especially cardiac). In this specific population, previous studies have shown that oral cyclophosphamide seems to have a promising activity, but also a very acceptable toxicity.\n\nThus, the GERICO study aims to compare standard doxorubicin chemotherapy with oral cyclophosphamide for the treatment of elderly patients with STS.",[144,174],[230,231,232,233],"Elderly","older patients","oral cyclophosphamide","doxorubicin","2025-03-24",{"date":236,"type":35},"2025-03-25",{"date":238,"type":35},"2021-06-18",{"date":240,"type":21},"2026-04",{"name":242,"class":42},"UNICANCER",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":269},"100450511","phase-1-multicohort-trial-of-different-schemes-of-pm14-in-monotherapy-and-in-combination-with-radiotherapy-in-soft-tissue-sarcomas-and-other-solid-tumor-100450511","NCT05146440","Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination with Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumor","Phase Ib\u002FII Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination with Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumors","PRIME","Inclusion Criteria:\n\nCohorts A, B, E, and F\n\n1. The patient must voluntarily sign the informed consent before any study test is conducted that is not part of routine patient care.\n2. Age: 18-75 years.\n3. Patients must have a diagnosis of soft tissue sarcoma with metastasis, and not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy. A centralized diagnosis confirmation will be performed and the tumor sample must be available and sent prior to inclusion to this end.\n4. A centralized diagnosis of DD liposarcoma or mixoid\u002Fhypercellular liposarcoma or leiomyosarcoma must be confirmed for patients in cohort E.\n5. A centralized diagnosis of other sarcomas includes: undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumors, sarcoma NOS, fibrosarcoma, pleomorphic rhabdomyosarcoma, pleomorphic liposarcoma, epithelioid sarcoma, clear cell sarcoma, dedifferentiated or aggressive features in solitary fibrous tumor, extraskeletal myxoid chondrosarcoma, angiosarcoma, epithelioid hemangioendothelioma,\n6. Patients must have received a previous chemotherapy line in advanced disease unless contraindicated or not indicated.\n7. Radiological disease progression must be documented within 6 months prior to study entry.\n8. The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced\u002Fmetastatic disease are allowed.\n9. Measurable disease according to RECIST v1.1 criteria.\n10. Performance status ≤1 (ECOG).\n11. Adequate bone marrow function (hemoglobin \\>10 g\u002FdL, neutrophils ≥ 1,500\u002Fmm3, platelets ≥ 100,000\u002Fmm3). Patients with creatinine clearance ≥ 30 mL\u002Fmin (Cockcroft and Gault's formula), transaminases ≤ 3.0 times the ULN, total bilirubin ≤ ULN, are acceptable.\n12. Men or women of childbearing potential must be using an effective method of contraception before entry into the study and throughout the same and for 3 months (men) and 6 months (women) after ending study treatment. Women of childbearing potential must have a negative serum or urine pregnancy test before study entry.\n13. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n14. HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).\n15. Patient must have a central venous catheter for PM14 treatment.\n\nCohort C\n\n1. The patient must voluntarily sign the informed consent before any study test is conducted that is not part of routine patient care.\n2. Age: 18-75 years.\n3. Patients must have a diagnosis of advanced soft tissue sarcoma, or recurrent head \\& neck suitable for reirradiation or other advanced or metastatic solid tumor not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy. A centralized diagnosis will be performed and the tumor sample must be available and sent prior to inclusion to this end. For phase II part, onlysoft tissue sarcomas will be enrolled.\n4. Patients must have received a previous chemotherapy line in advanced disease.\n5. Disease distribution must allow meeting with normal tissue constrains of radiation therapy. Radiation oncologist must confirm this point at local sites.\n6. Metastatic spread could be present in several organs (i.e. lungs and pelvic fossa) however, not all the locations have to be irradiated.\n7. Those lesions considered for radiation therapy have to be related to symptoms (for phase II).\n8. It is allowed that not all the lesions will be under radiation fields. As a general rule, the priority is to select, as target-irradiating lesions, those with greater increase in size and those largest lesions if related with symptoms. Irradiating pulmonary lesions with infiltration of pleural serosa is discouraged.\n9. Radiological disease progression must be documented within 6 months prior to study entry.\n10. The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced\u002Fmetastatic disease are allowed.\n11. The following histological subtypes can be included for the phase II part (central pathology review is mandatory before accrual): undifferentiated pleomorphic sarcoma (UPS), leiomyosarcoma, angiosarcoma, epithelial hemangioendothelioma, liposarcoma and its variants (well differentiated, dedifferentiated, myxoid\u002Fround cell, pleomorphic), synovial sarcoma, fibrosarcoma and its variants (epithelial fibrosarcoma\u002Flow grade fibromyxoid sarcoma), solitary fibrous tumor, malignant peripheral nerve sheath tumor (MPNST), myxofibrosarcoma, epithelioid sarcoma and (NOS) unclassified sarcoma.\n12. Measurable disease according to RECIST v1.1 criteria.\n13. Performance status ≤1 (ECOG).\n14. Adequate respiratory functions: FEV1 \\> 1L; DLco \\> 40% (patients with pulmonary target lesions).\n15. Adequate bone marrow function (hemoglobin \\> 10 g\u002FdL, neutrophils ≥ 1,500\u002Fmm3, platelets ≥ 100,000\u002Fmm3). Patients withcreatinine clearance ≥ 30 mL\u002Fmin (Cockcroft and Gault's formula), transaminases ≤ 2.5 times the ULN, total bilirubin ≤ ULN are acceptable.\n16. Men or women of childbearing potential must be using an effective method of contraception before entry into the study and throughout the same and for 3 months (men) and 6 months (women) after ending study treatment. Women of childbearing potential must have a negative serum or urine pregnancy test before study entry.\n17. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n18. HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).\n19. Patient must have a central venous catheter for PM14 treatment.\n\nCohort D\n\n1. The patient must voluntarily sign the informed consent before any study test is conducted that is not part of routine patient care.\n2. Age: 18-75 years.\n3. Patients must have a diagnosis of localized soft tissue sarcoma that lacks one or more of the following risk criteria: G3, deep and \\> 5 cm. At least G2 is required (i.e. G3, superficial and \\> 5 cm; or G3 \\\u003C 5 cm deep; or G2, deep and \\> 5 cm, etc.).\n4. Patients must be diagnosed by core-biopsy and the elapsed time between biopsy and enrollment must be shorter than 6 weeks.\n5. Patients must be diagnosed by central pathology review with one of the following subtypes: leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma, synovial sarcoma, sarcoma NOS, fibrosarcoma, myxoid liposarcoma,dedifferentiated liposarcoma, solitary fibrous tumor (the formerly malignant subtype).\n6. Only those sarcomas of limbs or trunk wall will be eligible for this cohort.\n7. Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point at local sites.\n8. Patients must have resectable primary tumor while it is allowed to enroll patients with metastatic spread that could be potentially resectable.\n9. Patients must have criteria of operability for the primary tumor.\n10. The patient must have been considered eligible for systemic chemotherapy.\n11. Measurable disease according to RECIST v1.1 criteria.\n12. Patients have to be candidates for MRI test.\n13. Performance status ≤ 1 (ECOG).\n14. Adequate bone marrow function (hemoglobin \\> 10 g\u002FdL, neutrophils ≥ 1,500\u002Fmm3, platelets ≥ 100,000\u002Fmm3). Patients withcreatinine clearance ≥ 30 mL\u002Fmin (Cockcroft and Gault's formula), transaminases ≤ 2.5 times the ULN, total bilirubin ≤ ULN are acceptable.\n15. Men or women of childbearing potential must be using an effective method of contraception before entry into the study and throughout the same and for 3 months (men) and 6 months (women) after ending study treatment. Women of childbearing potential must have a negative serum or urine pregnancy test before study entry.\n16. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n17. It should be performed HBV and HCV serologies prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).\n18. Patient must have a central venous catheter for treatment with PM14.\n\nExclusion Criteria:\n\nCohorts A, B, E, and F\n\n1. Performance status ≥ 2 (ECOG).\n2. Plasma bilirubin \\> ULN.\n3. Creatinine \\> 1.6 mg\u002FdL.\n4. History of other cancer with less than 5 years free of disease with the exception of adequately treated basal cell carcinoma or in situ cervical cancer.\n5. Patients who do not provide consent for mandatory biological samples (including those required for the translational study) cannot participate in the study.\n6. Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA).\n7. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v5.0 scale, that limit patient availability, or according to investigator judgment may significantly contribute to treatment toxicity.\n8. Uncontrolled bacterial, mycotic or viral infections.\n9. Women who are pregnant or breastfeeding.\n10. Psychological, family, social or geographic circumstances that limit the patients' ability to comply with the protocol or informed consent.\n11. Patients participating in another clinical trial or receiving any other investigational product.\n12. Patients who had participated in another clinical trial and\u002For had received any other investigational product in the last 30 days prior to inclusion.\n13. Histologies other than those described in the inclusion criteria.\n\nCohort C\n\n1. Previous treatment with radiotherapy (except if previous radiotherapy treatment plus planned study radiotherapy treatment allow tissue constrains).\n2. Performance status ≥ 2 (ECOG).\n3. Plasma bilirubin \\> ULN.\n4. Creatinine \\> 1.6 mg\u002FdL.\n5. History of other cancer with less than 5 years free of disease with the exception ofadequately treated basal cell carcinoma or in situ cervical cancer.\n6. Severe COPD or other severe pulmonary diseases.\n7. Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA).\n8. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v5.0 scale, that limit patient availability, or according to investigator judgment may significantly contribute to treatment toxicity.\n9. Patients who do not provide consent for mandatory biological samples (including those required for the translational study) cannot participate in the study.\n10. Uncontrolled bacterial, mycotic or viral infections.\n11. Women who are pregnant or breastfeeding.\n12. Psychological, family, social or geographic circumstances that limit the patients' ability to comply with the protocol or informed consent.\n13. Patients participating in another clinical trial or receiving any other investigational product.\n14. Patients who had participated in another clinical trial and\u002For had received any other investigational product in the last 30 days prior to inclusion.\n15. Histologies other than those described in inclusion criteria.\n\nCohort D\n\n1. High-risk localized patients are not allowed to be enrolled (those G3, deep, and larger than 5 cm or those with risk of death at least 40% by sarculator nomogram).\n2. Previous treatment with radiotherapy.\n3. Primary tumor location other than those indicated in the inclusion criteria.\n4. Histological subtypes other than those indicated in the inclusion criteria.\n5. Unresectable or inoperable primary tumor.\n6. Patients who do not provide consent for mandatory biological samples (including those required for the translational study) cannot participate in the study.\n7. Performance status ≥ 2 (ECOG).\n8. Plasma bilirubin \\> ULN.\n9. Creatinine \\> 1.6 mg\u002FdL.\n10. History of other cancer with less than 5 years free of disease with the exception of adequately treated basal cell carcinoma or in situ cervical cancer.\n11. Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA).\n12. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v5.0 scale, that limit patient availability, or according to investigator judgment may significantly contribute to treatment toxicity.\n13. Uncontrolled bacterial, mycotic or viral infections.\n14. Women who are pregnant or breastfeeding.\n15. Psychological, family, social or geographic circumstances that limit the patients' ability to comply with the protocol or informed consent.\n16. Patients participating in another clinical trial or receiving any other investigational product.\n17. Patients who had participated in another clinical trial and\u002For had received any other investigational product in the last 30 days prior to inclusion.",{"count":252,"type":21},195,[81,24],"Phase Ib\u002FII, multicohort, single arm, open-label, multicenter, international clinical trial, with 6 cohorts (advanced STS, advanced L-sarcomas, other advanced sarcomas, advanced solid tumors, and localized STS) with 4 sites in Spain for phase I.\n\nThe aim of this study is to explore different infusions of PM14 (longer or repeated) in order to obtain a potentially better efficacy and similar toxicity profile in advanced soft tissue sarcoma patients as monotherapy and also in other solid tumors as concomitant treatment with radiation therapy.\n\nTreatment\n\nCohort A\n\nA phase I dose-finding stage for PM14 is planned with an estimated number of 20-25 patients. PM14 will be tested at different dose levels in 24-h IV infusion on day 1 of 21-day cycles, up to progression or unacceptable toxicity. Premedication with dexamethasone is recommended on the day before treatment initiation.\n\nCohort B\n\nA phase I dose-finding stage for PM14 is planned with an estimated number of 20-25 patients. PM14 will be tested at different dose levels in 3-h IV infusion during 3 consecutive days (days 1-3) of 21-day cycles, up to progression or unacceptable toxicity. Premedication with dexamethasone is recommended on the day before treatment initiation.\n\nCohort E\n\nPM14 will be administered at the recommended phase II dose (RP2D) according to the most convenient scheme. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Cycles will be repeated every 21 days up to progression or unacceptable toxicity.\n\nCohort F\n\nPM14 will be administered at the RP2D according to the most convenient scheme. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Cycles will be repeated every 21 days up to progression or unacceptable toxicity.\n\nCohort C\n\nPhase I: PM14 will be administered at the RP2D according to the most convenient scheme in 21-day cycles, at at different dose levels in combination with radiotherapy, up to progression or unacceptable toxicity. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation and during 2 additional days (in the 24-hour infusion) and during 3 additional days (in the 3-hour infusion). Radiation therapy will start within 1 hour of PM14 infuser disconnection and will be administered with 3 Gy per fraction for 10 days (30 Gy in total).\n\nPhase II: PM14 will be administered at RP2D concomitant with radiation therapy.\n\nCohort D\n\nPhase I: PM14 will be administered at the RP2D according to the most convenient scheme, in up to 3 x 21-day cycles in neoadjuvant setting, at different dose levels in combination with radiotherapy. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Radiation therapy will start within 1 hour of PM14 infuser disconnection and will be administered with 1.8 Gy per fraction for 25 days (45 Gy in total).\n\nPhase II: PM14 will be administered at RP2D concomitant with radiation therapy.",[144,256,257,258,259],"Advanced L-sarcomas","Other Advanced Sarcomas","Advanced Solid Tumor","Localized Soft-tissue Sarcoma","2025-03-18",{"date":262,"type":35},"2025-03-21",{"date":264,"type":35},"2021-11-23",{"date":266,"type":21},"2026-05-31",{"name":268,"class":42},"Grupo Espanol de Investigacion en Sarcomas",4,{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":99},"100296375","phase-1-sainttrabectedin-ipilimumab-and-nivolumab-for-previously-treated-advanced-soft-tissue-sarcoma-100296375","NCT03138161","SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma","SAINT: A Phase 1\u002F2 Study of Safe Amounts of IPLIMUMAB, NIVOLUMAB and TRABECTEDIN for Previously Treated Advanced Soft Tissue Sarcoma (STS)","Inclusion Criteria:\n\n* Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:\n\n  * Male or Female ≥ 18 years of age\n  * Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma\n  * For the Phase 1 Part of Study, previously treated patients will be enrolled. For the Phase 2 Part of Study, previously treated patients will be enrolled.\n  * Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the investigator's IRB\u002FEthics Committee\n  * Willingness to comply with all study procedures and availability for the duration of the study.\n  * Measurable disease by RECIST v1.1\n  * ECOG performance status ≤1\n  * Life expectancy of at least 3 months\n  * Acceptable liver function: Bilirubin ≤ 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level ≤ 3.0 ULN);AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 3 x ULN (≤ 5 x ULN if liver metastases)\n  * Acceptable renal function: Creatinine ≤1.5 times ULN or ≥ 60 mL\u002Fmin (using the Cockcroft Gault formula)\n  * Acceptable hematologic status (without hematologic support): WBC ≥2000\u002FµL; ANC ≥ 1500 cells\u002FμL; Platelet count ≥ 100,000\u002FμL; Hemoglobin ≥ 9.0 g\u002FdL; Normal PT, PTT, INR\n  * All women of childbearing potential must have a negative pregnancy test and all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.\n\nExclusion Criteria:\n\n* All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation, as follows:\n\n  * Subjects with untreated CNS metastases. Subjects are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to treatment initiation. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment initiation.\n  * Subjects with carcinomatous meningitis\n  * Anticancer treatment with radiation therapy, chemotherapy, targeted therapy or other antitumor treatment within 2 weeks prior to study entry\n  * Subjects who participated in an investigational drug or device study within 14 days prior to study entry\n  * Females who are pregnant or breast-feeding\n  * Unwillingness or inability to comply with the study protocol for any reason\n  * Non-oncology vaccine therapy used for prevention of infectious disease within 4 weeks of trial enrollment\n  * • History of or known or suspected autoimmune disease (exception(s): patients with vitiligo, Type I diabetes, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at Screening are allowed). Other exceptions may be allowed following discussion with the Sponsor Medical Monitor for patients who have not received treatment for their autoimmune disorder in the past 3 years.\n  * Systemic immunosuppression, including HIV positive status with or without AIDS\n  * Skin rash (psoriasis, eczema) affecting ≥ 25% body surface area\n  * Inflammatory bowel disease (Crohn's or ulcerative colitis)\n  * Ongoing or uncontrolled diarrhea within 4 weeks of trial enrollment\n  * Recent history of acute diverticulitis, intraabdominal abscess or gastrointestinal obstruction within 6 months of trial enrollment, which are known risk factors for bowel perforation\n  * Patients with congestive heart failure or recent cardiac event\n  * Evidence of severe or uncontrolled systemic disease or any other concurrent condition, including psychiatric, which in the principal investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial\n  * Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection\n  * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n  * Inadequate hematologic, renal or hepatic function defined by any of the following screening laboratory values: WBC ≤2000\u002FµL; Neutrophils ≤1500\u002FµL; Platelets ≤ 100,000\u002FµL; hemoglobin ≤9.0 g\u002FdL; Serum creatinine ≥1.5 x ULN or creatinine clearance ≤ 60 mL\u002Fmin (using the Cockcroft Gault formula); AST\u002FALT ≥3 x ULN (≥ 5 x ULN if liver metastases); Total Bilirubin ≥1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level ≥ 3.0 ULN)\n  * Current, active or previous history of heavy alcohol abuse\n  * Pituitary endocrinopathy\n  * Adrenal insufficiency or excess",{"count":278,"type":21},250,[81,24],"This is an open label, dose-seeking phase 1\u002F2 study using escalating doses of TRABECTEDIN given intravenously with defined doses of IPILIMUMAB and NIVOLUMAB based on preliminary results of the Checkmate 012 trial for NSCLC (Hellman et al., 2016). For the Phase 1 Part of Study, only previously treated patients will be enrolled. For the Phase 2 Part of Study, previously treated patients will be enrolled.",[26,88],[283],"cancer immunotherapy, combination chemo-\u002Fimmunotherapy","2025-02-21",{"date":286,"type":35},"2025-02-24",{"date":288,"type":35},"2017-04-13",{"date":290,"type":21},"2031-07-31",{"name":292,"class":42},"Sarcoma Oncology Research Center, LLC",{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":99},"100506617","phase-1-linnovate-lurbinectedin-ipilimumab-and-nivolumab-for-soft-tissue-sarcoma-100506617","NCT05876715","LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma","LINNOVATE: A Phase 1\u002F2 Study of Safety\u002FEfficacy Using LURBINECTEDIN, Combined With IPILIMUMAB, and NIVOLUMAB for Advanced Soft Tissue Sarcomas","LINNOVATE","Inclusion Criteria:\n\nIndividuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:\n\n1. Male or Female ≥ 18 years of age\n2. Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma\n3. For the Phase 1 Part of Study, only previously treated participants will be enrolled. For the Phase 2 Part of Study, previously untreated participants will be enrolled.\n4. Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the principal investigator's IRB\u002FEthics Committee\n5. Willingness to comply with all study procedures and availability for the duration of the study.\n6. Measurable disease by RECIST v1.1\n7. ECOG performance status ≤ 1\n8. Life expectancy of at least 3 months\n\n   1. Acceptable liver function: Bilirubin \\\u003C 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \\\u003C 3.0 ULN);\n   2. AST (SGOT), ALT (SGPT) and alkaline phosphatase \\\u003C 3 x ULN (\\\u003C 5 x ULN if liver metastases)\n   3. Acceptable renal function: Creatinine \\\u003C 1.5 times ULN or \\> 60 mL\u002Fmin (using the Cockcroft Gault formula)\n9. Acceptable hematologic status (without hematologic support e.g. growth factors or transfusion within 21 days of first dose of study agents): ANC \\>= 1500 cells\u002FμL; Platelet count \\>= 100,000\u002FμL; Hemoglobin \\>= 9.0 g\u002FdL; Normal PT, PTT, INR\n10. All women of childbearing potential must have a negative pregnancy test and all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.\n\nExclusion Criteria:\n\nAll individuals meeting any of the exclusion criteria at baseline will be excluded from study participation, as follows:\n\n1. Subjects with untreated CNS metastases. Subjects are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to treatment initiation. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of \\\u003C10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment initiation.\n2. Subjects with carcinomatous meningitis\n3. Anticancer treatment with radiation therapy, targeted therapy or other antitumor treatment within 2 weeks prior to study entry. Anticancer treatment with chemotherapy within 21 days prior to study entry.\n4. Subjects who participated in an investigational drug or device study within 14 days prior to study entry\n5. Females who are pregnant or breast-feeding\n6. Unwillingness or inability to comply with the study protocol for any reason\n7. Concurrent or prior immunotherapy with anti-CTLA4 or anti-PD-1 inhibitors\n8. Non-oncology vaccine therapy used for prevention of infectious disease within 4 weeks of trial enrollment\n9. Autoimmune disease including rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis and motor neuropathy considered to be of autoimmune origin (e.g. Guillain-Barre Syndrome)\n10. Systemic immunosuppression, including HIV positive status with or without AIDS\n11. Skin rash (psoriasis, eczema) affecting \\> 25% body surface area\n12. Inflammatory bowel disease (Crohn's or ulcerative colitis)\n13. Ongoing or uncontrolled diarrhea within 4 weeks of trial enrollment\n14. Recent history of acute diverticulitis, intraabdominal abscess or gastrointestinal obstruction within 6 months of trial enrollment, which are known risk factors for bowel perforation\n15. Participants with congestive heart failure or recent cardiac event\n16. Evidence of severe or uncontrolled systemic disease or any other concurrent condition, including psychiatric, which in the principal investigator or sub-investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the trial\n17. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection\n18. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n19. Current, active, or previous history of heavy alcohol abuse\n20. Pituitary endocrinopathy\n21. Adrenal insufficiency or excess","90 Years",{"count":303,"type":21},40,[81,24],"This is an open label, dose-seeking phase 1\u002F2 study using escalating doses of LURBINECTEDIN administered intravenously with fixed doses of IPILIMUMAB and NIVOLUMAB administered intravenously.",[144],"2024-07-02",{"date":309,"type":35},"2024-07-05",{"date":311,"type":35},"2023-06-07",{"date":313,"type":21},"2026-09-30",{"name":315,"class":42},"ERLINDA M GORDON",{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":323,"targetDuration":4,"studyType":325,"phases":4,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":99},"100520927","geno-radiomics-based-model-for-evaluation-of-immunotherapy-and-targeted-therapy-for-advanced-soft-tissue-sarcoma-100520927","NCT06062927","Geno-radiomics Based Model for Evaluation of Immunotherapy and Targeted Therapy for Advanced Soft Tissue Sarcoma","Geno-radiomics Based Model for Response and Prognostic Evaluation of Immunotherapy and Targeted Therapy for Advanced Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Male or female subjects aged from 18 to 75 years old;\n* Subjects with histologically confirmed unresectable locally advanced or metastatic soft tissue sarcoma, which includes synoviosarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, fibrosarcoma, epithelioid sarcoma, angiosarcoma, alveolar soft-part sarcoma, etc. Chondrosarcoma, osteosarcoma, dermatofibrosarcoma protuberans, gastrointestinal stromal tumor and malignant mesothelioma are excluded;\n* Patients who agree to receive small molecule multi-target TKI and anti-PD-1 or anti-PD-L1 monoclonal antibody therapy, without contraindications in the use of related drugs;\n* Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Previously irradiated focus can be considered as measurable only if there is definite progress after radiotherapy;\n* Newly obtained or archived tumor tissue samples can be provided;\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at trial entry;\n* Estimated life expectancy of more than 12 weeks;\n* Adequate organ functions defined by the protocol;\n* Negative blood pregnancy test at Screening for women of childbearing potential within 1 week before the first medication; Highly effective contraception for both male and female subjects if the risk of conception exists; Able to comply with the research protocol and follow-up process for treatment and follow-up;\n* Already signed an informed consent form.\n\nExclusion Criteria:\n\n* Patients whose tumors are judged by the investigators to be at high risk of invading vital blood vessels and causing fatal hemorrhage during the study.\n* Occurrence of arterial\u002Fvenous thrombotic events within 6 months before treatment, such as cerebrovascular accident (including transient ischemic attack, hematencephalon and cerebral infarction), deep vein thrombosis , pulmonary embolism, etc.\n* Occurrence of clinically significant hemoptysis(\\>5ml fresh blood in 4 weeks), hemorrhagic tendency(bleeding\\>30ml within 3 months), such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood test(FOBT) ++ in the baseline period , or vasculitis, etc;\n* Hypertension that cannot be controlled stably by drugs, which is defined as: systolic blood pressure\\>140mmHg or diastolic blood pressure\\>90mmHg;\n* With clinically significant cardiovascular diseases, including but not limited to: acute myocardial infarction, severe\u002Funstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; congestive heart failure with New York Heart Association (NYHA) grade≥2; cardiac revascularization, hemodynamic unstable arrhythmia; Left ventricular ejection fraction(LVEF) \\\u003C50%;\n* QTc interval ≥ 480 milliseconds (ms) on electrocardiogram (ECG);\n* 24-h urinary protein level \\>1.0g\u002Fday;\n* Serum potassium, calcium (after correction for ionic or albumin-bound type) or magnesium are beyond the normal range and have clinical significance.\n* Abnormal coagulation function (INR\\>1.5 or PT\\>ULN+4s or APTT \\>1.5 ULN), hemorrhagic tendency or being treated with thrombolysis or anticoagulation therapy. Notes: on the premise of INR ≤ 1.5, it is allowed to use low-dose heparin (daily dosage of adults is 6000-12000U) or low-dose aspirin (daily dosage ≤ 100mg) for preventive purposes;\n* With factors affecting oral drug administration: dysphagia, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc\n* Presence of known active central nervous system metastasis and\u002For cancerous meningitis;\n* With any active, known or suspected autoimmune disease (subjects who are in stable status and do not need systemic immunosuppressant are allowed to be enrolled, such as subjects with type 1 diabetes, hypothyroidism requiring hormone replacement therapy only, skin diseases (leucoderma, psoriasis or alopecia) without the need for systemic treatment or subjects whose situation is not expected to reappear without extrinsic incentive);\n* Patients who are receiving systemic steroid treatment within 3 days before the first dose of trial drugs or any other form of immunosuppressive drugs. Notes: a. Corticosteroids can be used to deal with adverse reactions (AEs) and serious adverse reactions (SAEs) after period 1, and can also be used as a pre-medication for the control chemotherapy group, as a preventive drug for the allergy\u002Freaction of intravenous contrast enhanced radiography, or if it is considered necessary for the subject to use. b. Except for the subjects who are receiving steroid replacement therapy every day. A daily dose of 5-7.5 mg of prednisone is an alternative treatment. c. Equivalent dose of hydrocortisone treatment can also be allowed to enter the trial if it is an alternative treatment.\n* With any clinically significant active infection, including but not limited to: active tuberculosis, infection of Human immunodeficiency virus (HIV);\n* HBV DNA of patients with chronic hepatitis B virus (HBV) infection must be \\\u003C100 IU\u002FmL, and antiviral treatment should be carried out at the same time;\n* Previous malignant disease within the last 5 years with the exception of post radical resection of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ;\n* Anticancer treatment within 4 weeks before the research, including but not limited to: chemotherapy, radical radiotherapy, targeted therapy, immunotherapy, antitumor traditional Chinese medicine\u002F Chinese patent medicine, transcatheter arterial chemoembolization, Cryoablation or radiofrequency ablation of liver metastases;\n* History of receiving anti-angiogenic drugs such as surufatinib, bevacizumab, ramucirumab, aflibercept, anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, fruquintinib, endostatin, etc.\n* History of receiving anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs directly acting on another stimulatory or co-inhibitory T cell receptor (such as CTLA-4, OX-40, CD137, LAG3);\n* History of allergy to any component of surufatinib and envafolimab;\n* Accination with live or live\u002Fattenuated viruses within 4 weeks of the first dose of surufatinib\u002F envafolimab and while on trial is prohibited;\n* Have major surgery, severe traumatic injuries, fracture or ulcer within 4 weeks before treatment;\n* Pregnant or lactating women;\n* Participate in other clinical trials at present or within four weeks before enrollment;\n* According to the judgment of the researchers, the subject has other factors that may lead to the forced termination of the study, such as other severe diseases (including mental diseases) which need to be treated together, severe laboratory abnormalities , family or social factors.",{"count":324,"type":21},60,"OBSERVATIONAL","In this study, a new post-processing image technology - radiomics is used to screen out parameters of CT and MRI images, which could effectively evaluate the efficacy and prognosis of immunotherapy plus targeted therapy for soft tissue sarcoma (STS). A reliable and effective model for predicting the prognosis of STS will be established based on the radiomic parameters combined with traditional imaging, histophiological, whole exome sequencing (WES) results, inflammatory indicators and changes in the number and function of lymphocyte subsets before and after medication. Patients with advanced STS who may benefit from the combination therapy can be found out by this model.",[26],"2023-09-25",{"date":330,"type":35},"2023-10-02",{"date":332,"type":35},"2023-02-02",{"date":334,"type":21},"2027-02-02",{"name":336,"class":42},"Peking Union Medical College Hospital",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":344,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":99},"100486947","study-of-ny-eso-1-tcr-t-in-advanced-soft-tissue-sarcoma-100486947","NCT05620693","Study of NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma","Study NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Aged 18-70 (≥ 18, ≤ 70), regardless of gender;\n2. Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form;\n3. Late recurrent or metastatic soft tissue sarcoma confirmed by histopathology; Progress after receiving first-line treatment;\n4. According to RECIST 1.1 standard, there are clear assessable lesions;\n5. The expression of NY-ESO-1 in tumor tissue was confirmed by immunohistochemical staining; HLA-A configuration is 02\u002F01;\n6. Within 2 weeks before cell therapy, no antibody drugs were used;\n7. ECOG score is 0-2;\n8. The subject has no contraindication for peripheral blood collection;\n9. The expected survival period is more than 3 months.\n\nExclusion Criteria:\n\n1. People who have a history of allergy to any component in cell products;\n2. The following conditions occur in blood routine examination: WBC ≤ 1 × 109\u002FL, absolute value of neutrophil ANC ≤ 0.5 × 109\u002FL, absolute value of lymphocyte ALC ≤ 0.5 × 109\u002FL , PLT≦25 × 109\u002FL ；\n3. The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg\u002Fdl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg\u002Fdl;\n4. According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)\\\u003C50% by echocardiography;\n5. Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%;\n6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment;\n7. Grade 3 hypertension and poor blood pressure control after drug treatment;\n8. Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past;\n9. Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment;\n10. There is uncontrolled active infection;\n11. Have used any cell therapy products in recent 3 months;\n12. Live vaccine inoculation within 4 weeks before enrollment;\n13. HIV, HBV, HCV and TPPA\u002FRPR positive persons, and HBV carriers;\n14. Subjects have a history of alcohol abuse, drug abuse or mental illness;\n15. Subjects have participated in any other clinical research within 3 months before joining this clinical research;\n16. Female subjects have any of the following conditions: a) are in pregnancy\u002Flactation; Or b) having a pregnancy plan during the trial; Or c) is fertile and unable to take effective contraceptive measures;\n17. The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study.","70 Years",{"count":346,"type":21},20,[348],"NA","Soft tissue sarcoma (STS) is a kind of solid tumor with high heterogeneity. There is no standard second-line treatment plan for patients who have failed first-line treatment. NY-ESO-1, a cancer testis antigen, is highly expressed in soft tissue tumors and is an ideal therapeutic target.\n\nInvestigators aim to testify the safety and efficacy of NY-ESO-1 TCR-T cell in advanced soft tissue sarcoma.",[144],"2022-11-17",{"date":353,"type":35},"2022-11-22",{"date":355,"type":35},"2022-11-11",{"date":357,"type":21},"2028-12-01",{"name":359,"class":42},"Shenzhen University General Hospital"]