sarcoma
Conditions
Interventions
Sponsors
The Children’s Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
2 Years to 12 Years
Inclusion criteria
Inclusion criteria: Potential participants must meet all of the criteria listed below to be selected for this study. If there are multiple clinical laboratory results during the screening period, the test results closest to the date of administration must be used to demonstrate the subject's eligibility for inclusion in this study. 1. Age 24 months-12 years old (including boundary value), male or female; 2. Lansky score >= 50 (Annex 7); 3. Confirmed by histopathology as pediatric sarcoma; 4. Patients with progression, relapse or refractory (failing to obtain complete or partial remission after recent treatment) after first-line treatment; 5. Have at least 1 measurable lesion according to RECIST1.1 criteria; 6. Expected survival>= 3 months; 7. Major organ function is normal and meets the following criteria within 7 days prior to treatment: (1) The criteria for routine blood examination shall meet: 1) absolute neutrophil count (ANC) >=1,000/uL (not receiving short-acting GSCF within 7 days or not receiving long-acting GCSF within 14 days); 2) platelet count (PLT) >=75,000/UL (not dependent on blood transfusion, defined as not receiving platelet transfusion within 7 days prior to enrollment); 3) hemoglobin (HB) >= 7.50 g/dL (RBC transfusion can be received); (2) Biochemical examination should meet the following standards: 1) Total bilirubin (TBiL) = lower limit of normal value (50%) (6) Thyroid function: TSH <= upper limit of normal value (ULN); T3 and T4 levels should be considered if abnormal, and normal T3 and T4 levels can be enrolled; 8. Be able to adhere to outpatient treatment, laboratory monitoring, and necessary clinical visits during the study.
Exclusion criteria
Exclusion criteria: Potential participants who meet any of the following criteria must be excluded from the study: 1. Have received myelosuppressive chemotherapy within 2 weeks prior to enrollment (or 6 weeks if nitrosourea was previously used); 2. Have received any type of immunotherapy (except steroids) within 6 weeks prior to enrollment, such as anti-PD-1/PD-L1/CTLA-4 antibodies, tumor vaccines; 3. Received local palliative radiotherapy (XRT) (small mouth) within 2 weeks prior to enrollment, or received massive bone marrow irradiation within 6 weeks prior to enrollment, or received stem cell transplantation or injection without total body irradiation (TBI) within 12 weeks prior to enrollment, or received total body irradiation (TBI) within 24 weeks prior to enrollment; 4. Have participated in or are in other clinical trials of antineoplastic drugs within 4 weeks prior to enrollment; 5. Plan systemic antitumor therapy or external beam or other interventional treatments, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, during the use of this study; 6. Have previously received anlotinib hydrochloride or other small molecule antiangiogenic TKI drugs (such as sunitinib, sorafenib, imatinib, famitinib, apatinib, etc.), or anti-angiogenic monoclonal antibody drugs (such as valizumab); 7. Have not recovered to NCI-CTCAE (5.0) grade 10mmol/L); 3) Significant cardiovascular damage including but not limited to: unstable angina; myocardial ischemia or myocardial infarction; >= grade 2 congestive heart failure (NYHA score of New York Heart Association level); Arteriovenous thrombotic events within 6 months, such as cerebrovascular accident (including transient ischaemic attack), deep vein thrombosis, and pulmonary embolism; 4) Sinus bradycardia above grade I; or second-degree atrioventricular block, or sinus arrest (except with pacemakers); arrhythmias (including QTc >=480ms); It needs to be taken at the same time with drugs that can prolong the QTc interval; 5) Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; 6) Renal failure requires hemodialysis or peritoneal dialysis; 7) Have a history of immunodeficiency, including HIV-positive or other active or congenital immunodeficiency diseases, a history of organ transplantation, a history of hematopoietic stem cell transplantation, or 2 weeks before enrollment being receiving systemic corticosteroids or any other form of immunosuppressive therapy; Note: In the absence of active autoimmune diseases, inhaled or topical steroids and doses > 10 mg/day of prednisone equivalent doses of adrenal corticosteroids are allowed, Adrenocorticoid replacement therapy at a response dose of 10 mg/day of prednisone is permitted, glucocorticoids to be used as prophylaxis for hypersensitivity reactions is consented (e.g., docetaxel pre-drug prophylaxis); 8) active or uncontrolled severe infection (>= CTC AE grade 2 infection) within 4 weeks prior to enrollment; 9) The presence of active brain metastases (stable and asymptomatic brain metastases within 2 weeks prior to enrollment) was judged by imagingcan be enr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose-limiting toxicity;maximum tolerated dose;Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS (Progress Free Survival);OS (Overall Survival);ORR (Objective Response Rate);DCR (Disease Control Rate); | — |
Countries
China
Contacts
Public ContactJinhu Wang
The Children’s Hospital, Zhejiang University School of Medicine
Outcome results
None listed