[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"angiosarcoma-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:angiosarcoma-metastatic":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100567856","phase-2-pembrolizumab-plus-lenvatinib-in-unresectable-cutaneous-angiosarcoma-patients-100567856",false,"NCT06673628","Pembrolizumab Plus Lenvatinib in Unresectable Cutaneous Angiosarcoma Patients","The Phase II Study of Pembrolizumab Plus Lenvatinib in Patients With Unresectable Cutaneous Angiosarcoma","PLAS","Inclusion Criteria:\n\n1. Histologically diagnosed with cutaneous angiosarcoma.\n2. Unresectable primary or metastatic disease.\n3. No spinal metastases that require radiotherapy or surgical intervention.\n4. No pericardial effusion, pleural effusion, or ascites that require treatment.\n5. Age at enrollment: 18 years or older and 85 years or younger.\n6. The most recent performance status score (ECOG) within 14 days prior to enrollment is 0 or 1.\n7. A contrast-enhanced CT\u002FMRI (head, neck, chest, abdomen, pelvis: slice thickness 5 mm or less) performed within 14 days prior to enrollment or have at least one measurable lesion that can be confirmed to be present on the surface of the body by visual inspection (for patients with contrast allergy or renal function deterioration, plain CT is allowed).\n8. Cohort A (untreated patients): Cutaneous angiosarcoma without prior therapy. Cohort B (previously treated patients): Cutaneous angiosarcoma with prior therapy.\n9. Have adequately controlled BP with or without antihypertensive medications (of 2 or less counted by components), defined as BP \\\u003C=150\u002F90 mmHg with no change in antihypertensive medications within 7 days prior to enrollment.\n10. Wounds (e.g., those after a surgical procedure or trauma) have healed at enrollment.\n11. Did not have major surgery within 21 days prior to the first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.\n12. Laboratory tests performed within 14 days before the enrollment date meet the following criteria: (1) to (10). However, patients should not receive granulocyte colony-stimulating factor (G-CSF) or blood transfusions within 14 days before the day of blood collection.\n\n(1) Neutrophil count \\>=1,500\u002Fmm3 (2) Platelet count \\>=10×104\u002Fmm3 (3) Hemoglobin \\>=9.0 g\u002FdL (4) AST \\\u003C=100 U\u002FL (5) ALT\\\u003C=100 U\u002FL (6) Total bilirubin \\\u003C=1.5 mg\u002FdL (7) Serum creatinine \\\u003C=1.5 mg\u002FdL (8) Creatinine\u002Fclearance \\>=30 mL\u002Fmin (Cockcroft-Gault). (Even if the calculated value is less than 30 mL\u002Fmin, it can be registered if the value is more than 30 mL\u002Fmin by the 24-hour urine collection method).\n\n(9) Urine protein \\\u003C1 g\u002F24 hours. Note: Participants with proteinuria \\>=2+ on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n\n(10) PT-INR \\\u003C=1.5 13) Male patients agree to use highly effective contraception and not donate sperm during treatment and for at least 120 days after the last dose of the investigational drugs.\n\nFemale patients agree to use contraception methods, are not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n* Is not a woman of childbearing potential (WOCBP).\n* Is a WOCBP tested negative by pregnancy test within 14 days prior to enrollment, and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 120 days post pembrolizumab or 30 days post lenvatinib, whichever occurs last. A WOCBP must have a negative result of a highly sensitive pregnancy test within 24 hours before the first dose of study intervention.\n\n  14\\) Twenty-eight days have passed since the last day of prior chemotherapy if applicable, and the patient has recovered from all toxicities except alopecia and blood toxicity (below Grade 1 or to baseline).\n\n  15\\) Written informed consent for study participation has been obtained from the patient.\n\nExclusion Criteria:\n\n1. Persons previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or agents targeting other co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).\n2. Individuals previously treated with lenvatinib or another angiogenesis inhibitor, including treatment for other cancer types.\n3. Patients who are likely to be cured with chemoradiotherapy, at the discretion of the treating physician.\n4. Patients who received radiation therapy within 14 days prior to enrollment or patients with radiation therapy-related toxicities at enrollment.\n5. Patients positive for either HIV antibody, HBs antigen, or HCV antibody.\n6. Patients of HBs antigen-negative, HBs antibody, or HBc antibody-positive, and HBV-DNA assay-positive.\n7. Patients receiving live or live attenuated vaccines within 30 days of enrollment.\n8. Patients who received other investigational products or used investigational medical devices within 28 days prior to enrollment.\n9. Patients diagnosed as being in an immunocompromised state or patients treated with long-term systemic steroidal therapy or other immunosuppressive therapies in the 14 days prior to enrollment.\n10. Patients with other malignancies requiring progressive or aggressive treatment within the past 3 years.\n11. Patients with active CNS metastases or carcinomatous meningitis.\n12. Patients with severe (\\>= Grade 3) hypersensitivity to pembrolizumab or lenvatinib additives.\n13. Patients with active autoimmune disease requiring systemic treatment, excluding replacement therapy within the past 2 years.\n14. Patients with a history of interstitial lung disease\u002Fpneumonitis complicated by interstitial lung disease\u002Fpneumonitis or interstitial lung disease\u002Fpneumonitis requiring steroid administration (non-infectious).\n15. Patients with active infections requiring systemic treatment at enrollment.\n16. Patients with preexisting \\>=Grade 3 gastrointestinal or non-gastrointestinal fistula at enrollment.\n17. Patients with gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n18. Patients with a history of acute coronary syndrome, coronary angioplasty, or stenting within 6 months prior to enrollment.\n19. Patients with clinically significant cardiovascular diseases within the 12 months prior to enrollment.\n20. Patients having left ventricular ejection fraction (LVEF) below 50% within 14 days before the date of enrollment.\n21. Patients with complications requiring hospitalization.\n22. Patients with radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n23. Patients with QTcF spacing prolongation beyond 480 msec within 14 days prior to enrollment.\n24. Patients with active hemoptysis in the 21 days prior to enrollment.\n25. Patients who have comorbid psychotic or psychiatric symptoms or substance use disorders that interfere with daily life.\n26. Patients with a history of allogeneic transplantation.","ALL","18 Years","85 Years",{"count":21,"type":22},38,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Cutaneous angiosarcoma is a rare cancer for which effective treatment has not been developed sufficiently. Still, because it often occurs in elderly people, the number of patients is increasing due to the aging population. Cutaneous angiosarcoma is difficult to completely remove by surgery, and recurrence and metastasis after surgery are not uncommon. Therefore, chemotherapy, radiation therapy, and a combination of these are currently widely used as treatments. Traditionally, the anticancer drug used for cutaneous angiosarcoma was mainly doxorubicin. In recent years, it has been reported that cancer shrank in 18% of patients after two months of paclitaxel administration in a clinical trial. Therefore, paclitaxel has become more commonly used for cutaneous angiosarcoma. Other options include anthracycline anticancer drugs and gemcitabine. However, even with these anticancer drugs (and radiation therapy), cutaneous angiosarcoma progresses quickly, and some reports have said that the 5-year survival rate is 9%. This study is planned to develop a safer and more effective treatment for cutaneous angiosarcoma and will include 38 participants. In this study, eligible participants will receive combination chemotherapy with 200 mg of pembrolizumab (injection liquid, once every 3 weeks) and 20 mg of lenvatinib (capsule, once daily) for up to approximately two years as protocol treatment unless the criteria for termination meet. Before, during, and after the protocol treatment, participants will undergo many examinations and evaluations, including blood tests, urine tests, and imaging tests (e.g., x-ray, CT scan, or MRI) to assess the safety and efficacy of the protocol treatment.",[28,29],"Angiosarcoma of Skin","Angiosarcoma Metastatic",[31,32],"pembrolizumab","lenvatinib","RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2024-12-01",{"date":41,"type":22},"2029-11-30",{"name":43,"class":44},"National Cancer Center, Japan","OTHER_GOV",6,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100428470","phase-2-albumin-bound-paclitaxel-combined-with-liposomal-doxorubicin-in-the-treatment-of-advanced-or-unresectable-angiosarcoma-100428470","NCT04859465","Albumin-bound Paclitaxel Combined With Liposomal Doxorubicin in the Treatment of Advanced or Unresectable Angiosarcoma","Albumin-bound Paclitaxel Combined With Liposomal Doxorubicin in the Treatment of Advanced or Unresectable Angiosarcoma--an Open, Single Arm, Multicenter Phase II Study","Inclusion Criteria:\n\n1. The patients voluntarily participated in the study and signed the informed consent; In all advanced angiogenic sarcomas confirmed by pathology, the standard treatment failed or there was no standard treatment or the standard treatment could not be tolerated. There is at least one measurable lesion according to RECIST 1.1, mainly including angiosarcoma, epithelioid hemangioendothelioma, epitheliosarcoma hemangioendothelioma, pseudomyogenic hemangioendothelioma, Kaposi sarcoma, malignant solitary fibroma \u002F hemangiopericytoma, malignant glomus tumor, etc.\n2. Patients in advanced stage with unresectable lesions or lymph node or distant metastasis by imaging evaluation;\n3. In the past three months, there was at least one target lesion that could be measured according to RECIST version 1.1 standard, and it could be accurately measured in at least one direction (the maximum diameter needs to be recorded) by MRI or CT, including conventional CT ≥ 20 mm or spiral CT ≥ 10 mm.\n4. 18-70 years old; ECOG PS score: 0-1; the expected survival time was more than 3 months;\n5. The main organ function met the following criteria within 7 days before treatment (1) Blood routine examination standard (without blood transfusion within 14 days)\n\n   * Hemoglobin (HB) ≥ 90g \u002F L; ② Absolute neutrophil count (ANC) ≥ 1.5 × 109 \u002F L;\n\n     ③ Platelet count (PLT) ≥ 80 × 109 \u002F L.\n\n     (2) Biochemical tests should meet the following standards:\n   * Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); ② Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 × ULN ALT and AST ≤ 5 ×ULN in patients with liver metastasis; ③ Serum creatinine (CR) ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60ml \u002F min;\n\n     (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value (50%).\n6. Women of childbearing age should agree to use contraceptive measures (such as intrauterine device, contraceptive or condom) during the study period and within 6 months after the end of the study; women with negative serum or urine pregnancy test within 7 days before the study and must be non lactation patients; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.\n\nExclusion Criteria:\n\n1\\) Patients who have previously received abraxane treatment.\n\n2\\) There were other malignant tumors in the past 5 years or at the same time, except for the cured cervical carcinoma in situ, skin cancer without melanoma and superficial bladder tumor (TA (non invasive tumor), tis (in situ cancer) and T1 (tumor infiltrating basement membrane);\n\n3\\) Systemic anti-tumor treatment, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C use within 6 weeks prior to the treatment of the trial drug), is planned within 4 weeks before the group is given or during the study medication. The radiotherapy was performed within 4 weeks before the group or the limited field radiotherapy was performed within 2 weeks before the group;\n\n4\\) With pleural effusion or ascites, respiratory syndrome (≥ CTC AE class 2 dyspnea (dyspnea 2 refers to shortness of breath when a small amount of activity is used; It can affect instrumental daily life activities);\n\n5\\) No remission of toxic reactions caused by any previous treatment was higher than that of CTC AE (4.01), excluding hair loss and lymphocyte reduction;\n\n6\\) Patients with any serious and \u002F or uncontrollable diseases, including:\n\n1. The patients with poor blood pressure control (systolic pressure ≥ 150 mmHg and diastolic pressure ≥ 100 mmHg) were found;\n2. Patients with myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480ms) and ≥ 2 congestive heart failure (NYHA classification);\n3. Active or uncontrollable severe infection (≥ CTC AE Level 2 infection);\n4. Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need to be treated with antiviral treatment;\n5. Renal failure requires hemodialysis or peritoneal dialysis;\n6. The control of diabetes mellitus was not good (FBG) was more than 10mmol\u002Fl;\n7. The routine urine suggested that the urine protein was ≥ + +, and the 24-hour urine protein was more than 1.0 G;\n8. Patients with epilepsy and need treatment;\n\n7\\) The patients were treated with major surgery, incision biopsy or obvious traumatic injury within 28 days before entering the group;\n\n8\\) Patients with any signs of bleeding constitution or history, regardless of severity; In the 4 weeks before entering the group, there were unconnected wounds, ulcers or fractures in patients with bleeding or bleeding events ≥ CTCAE Level 3;\n\n9\\) The patients with arteriovenous thrombosis occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;\n\n10\\) The patients with active ulcer, perforation and obstruction of intestine;\n\n11\\) The patients had clinical symptoms of central nervous system metastasis (such as brain edema, hormone intervention, or brain metastasis progress); Patients who have received brain or meningeal metastasis treatment before, such as clinical stability (MRI) have been maintained for at least 2 months, and patients who have stopped systemic hormone therapy (dose \\> 10mg \u002F day prednisone or other therapeutic hormone) for more than 2 weeks can be included;\n\n12\\) The subjects were using immunosuppressant, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose \\> 10mg \u002F day prednisone or other therapeutic hormone), and were still in use within 2 weeks before entering the group;\n\n13\\) The subjects had any active autoimmune disease or had a history of autoimmune disease (such as, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; If the subjects had vitiligo or had been completely relieved in childhood asthma, no intervention was needed in adult; Asthma in which the subjects needed bronchodilators to intervene in medicine could not be included;\n\n14\\) Subjects had active tuberculosis and immunodeficiency history including human immunodeficiency virus (HIV) or other acquired or congenital immunodeficiency disease or active hepatitis (transaminase does not conform to inclusion, hepatitis B virus (HBV) DNA ≥ 104\u002F ml or hepatitis C virus seropositive (HCV) RNA ≥ 103\u002Fml or higher); Chronic hepatitis B virus carriers with HBV DNA \\\u003C 2000 iu\u002Fml (\\\u003C 104 \u002F ml) must be treated with antiviral therapy throughout the study.\n\n15\\) According to the researchers' judgment, the subjects are not suitable for entering the group or other factors may lead to the termination in the middle of the course. For example, other serious diseases (including mental diseases) need to be treated together, there are serious laboratory abnormalities, and family or social factors, which will affect the safety of the subjects, or the collection of test data and samples;\n\n16\\) The clinical trials of other anti-tumor drugs were conducted 28 days before entering the group.","70 Years",{"count":55,"type":22},69,[25],"The purpose is to explore the efficacy and safety of the combination of albumin-bound paclitaxel and liposomal doxorubicin in the treatment of advanced or unresectable angiosarcoma.",[29],"2026-06-10",{"date":61,"type":37},"2026-06-12",{"date":63,"type":37},"2021-05-21",{"date":65,"type":22},"2027-11-20",{"name":67,"class":68},"Sun Yat-sen University","OTHER",1]