[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620302":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":26,"locations":32,"responsibleParty":46,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ATRA+VAC","EXPERIMENTAL",null,[13],"Drug: ATRA+VAC",{"label":15,"type":10,"description":11,"interventionNames":16},"ATRA+VAC+Anlotinib",[17],"Drug: ATRA+VAC+Anlotinib",[19,23],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","Cohort 1: Intermediate-risk RMS: ATRA+VAC treatment\n\nThe specific medication is:\n\nVincristine (V), administered intravenously, at a dose of 1.5 mg\u002Fm2 (with a maximum of 2 mg), on days 1, 8, and 15, every three weeks.\n\nDactinomycin (A), intravenous infusion, 1.25mg\u002Fm2 (maximum not exceeding 2.5mg), D1, q3w.\n\nCyclophosphamide (C), intravenous infusion, 1200mg\u002Fm2, D1, q3w. All-trans-retinoic acid: provided free of charge by Shandong Liangfu Pharmaceutical Co., Ltd. Capsules, 10mg\u002Fcapsule, 20mg bid, orally, administered continuously every day, with 21 days constituting one course of treatment. If safety is confirmed, the dosage can be increased to 30mg bid.",[9],{"type":20,"name":15,"description":24,"armGroupLabels":25,"otherNames":11},"Cohort 2: High risk group RMS+: ATRA+VAC, ATRA+anlotinib maintenance therapy\n\nThe specific medication is:\n\nVincristine (V), static push, 1.5 mg\u002Fm2 (maximum not exceeding 2mg), D1, 8, 15, q3w.\n\nDactinomycin (A), intravenous drip, 1.25mg\u002Fm2 (maximum not exceeding 2.5mg), D1, q3w.\n\nCyclophosphamide (C), intravenous infusion, 1200mg\u002Fm2, D1, q3w. After chemotherapy, Anlotinib, 12mg, d1-d14, po, q3w+ATRA maintenance therapy. Both are maintained for a period of time until disease progression or toxicity is intolerable, or for at least 2 years.\n\nAll trans retinoic acid: provided free of charge by Shandong Liangfu Pharmaceutical Co., Ltd., capsule, 10mg\u002Fcapsule, 20mg bid orally, administered continuously daily for 21 days as a course of treatment. If safety is ensured, the dosage will be increased to 30mg bid.",[15],[27],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"xin Liu","CONTACT","021-64175590-88503","jeanettexin@hotmail.com",[33],{"facility":34,"status":11,"city":35,"state":11,"zip":11,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Fudan university cancer hospital","Shanghai","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},[45],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Zhiguo Luo, MD, PhD","Chief Physician","100620302","phase-2-a-clinical-study-on-the-efficacy-and-safety-of-all-trans-retinoic-acid-combined-with-vac-regimen-in-the-treatment-of-intermediate-to-high-risk-rhabdomyosarcoma-100620302",false,"NCT07355855","A Clinical Study on the Efficacy and Safety of All-trans Retinoic Acid Combined With VAC Regimen in the Treatment of Intermediate-to-high-risk Rhabdomyosarcoma","A Multicenter, Multi-cohort, Prospective Phase II Clinical Study on the Efficacy and Safety of All-trans Retinoic Acid Combined With VAC Regimen in the Treatment of Intermediate-to-high-risk Rhabdomyosarcoma","Inclusion Criteria:\n\n1. Age ≥ 14 years old and ≤ 60 years old;\n2. Histologically confirmed medium to high risk rhabdomyosarcoma (excluding pleomorphic rhabdomyosarcoma);\n3. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0-1;\n4. Have not received any anti-tumor drug treatment in the past;\n5. Expected survival time ≥ 3 months;\n6. Possess sufficient organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to enrollment (no blood components, cell growth factors, albumin, or other corrective treatment drugs are allowed within 14 days prior to obtaining laboratory tests), as follows Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelet count (PLT) ≥ 100 × 109\u002FL, hemoglobin (HGB) ≥ 100 g\u002FL (no transfusion or erythropoietin dependence within 14 days) Liver function: serum total bilirubin ≤ 1.25 times the upper limit of normal (ULN); ALT and AST ≤ 2.5 x ULN (≤ 5x ULN for patients with liver metastases); Serum albumin ≥ 30 g\u002FL; Alkaline phosphatase (ALP) ≤ 5 × ULN.\n\n   Renal function: Serum creatinine (Cr) ≤ 1.25 × ULN, or creatinine clearance rate ≥ 60 mL\u002Fmin (using the standard Cockcroft Gault formula): Urine routine results show urinary protein\\\u003C2+; For patients whose baseline urine routine test shows urinary protein ≥ 2+, 24-hour urine collection should be performed with a 24-hour urine protein quantification of\\\u003C1g.\n\n   Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the INR is within the intended range of use of the anticoagulant drug.\n7. For female subjects of childbearing age, a urine or serum pregnancy test should be conducted 3 days before receiving the first study drug and the result should be negative;\n8. Participants and their sexual partners are required to use a medically approved contraceptive measure (such as intrauterine devices, birth control pills, or condoms) during the study treatment period and within 6 months after the end of the study treatment period.\n\nExclusion Criteria:\n\n1. Previously received anti-tumor treatment other than surgery and radiation therapy for any malignant tumor;\n2. Subjects who cannot accept or tolerate this chemotherapy regimen for various reasons;\n3. Biopsy confirmed a patient with bone marrow infiltration;\n4. Patients who have undergone major surgical procedures unrelated to medium to high risk rhabdomyosarcoma within the 4 weeks prior to enrollment, or who have not fully recovered from such surgical procedures;\n5. Serious heart disease or discomfort, including but not limited to the following diseases:\n\n   * Diagnosed history of heart failure or systolic dysfunction (LVEF\\\u003C50%);\n   * High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate\\>100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block);\n   * Angina requiring treatment with anti angina drugs;\n   * Clinically significant heart valve disease;\n   * ECG shows transmural myocardial infarction;\n   * Poor control of hypertension (systolic blood pressure\\>180mmHg and\u002For diastolic blood pressure\\>100mmHg)\n6. Individuals with a known history of allergies to the components of this medication regimen;\n7. The researcher believes that the patient is not suitable to participate in any other circumstances of this study.","ALL","14 Years","60 Years",{"count":61,"type":62},106,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","This study is a prospective, multi-cohort, multi-center clinical trial targeting patients with intermediate-to-high-risk rhabdomyosarcoma who have not previously received systemic anti-tumor treatment. It aims to evaluate the efficacy and safety of all-trans retinoic acid combined with VAC chemotherapy.",[68],"Rhabdomyosarcoma","NOT_YET_RECRUITING","2026-01-13",{"date":72,"type":73},"2026-01-21","ACTUAL",{"date":75,"type":62},"2026-01",{"date":77,"type":62},"2029-01",{"name":5,"class":6},1]