Sarcoma
Conditions
Interventions
Treatment group:Anlotinib+Temozolomide+Irinotecan Liposome
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Written informed consent must be signed prior to any trial-related procedures; 2.Age >=12 years, regardless of gender; 3.Histopathologically confirmed diagnosis of Ewing sarcoma, embryonal rhabdomyosarcoma, or alveolar rhabdomyosarcoma; 4.Patients with locally advanced or metastatic disease who failed standard first-line chemotherapy and are unable to undergo local therapy (surgery or radiotherapy); 5.Washout period from prior therapy: >=3 weeks for systemic therapy; >=2 weeks for radiotherapy or surgery; 6.At least one radiologically measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1); 7.ECOG performance status of 0-1; 8.Life expectancy >3 months; 9.Adequate organ function, meeting the following laboratory criteria: a) Absolute neutrophil count (ANC) >=1.5×10^9/L without granulocyte colony-stimulating factor support within 14 days; b) Platelets >=100×10^9/L without transfusion within 14 days; c) Hemoglobin >9 g/dL without transfusion or erythropoietin use within 14 days; d) Total bilirubin =60 mL/min; g) Normal coagulation: International normalized ratio (INR) or prothrombin time (PT) =1 year post-menopause, surgical sterilization, or hysterectomy; 11.All subjects (male or female) with reproductive risk must use contraception with an annual failure rate <1% during treatment and for 120 days after the last dose.
Exclusion criteria
Exclusion criteria: 1.Coagulation disorders; 2.Administration of live vaccines within 4 weeks prior to study drug initiation or anticipated during the study; 3.Current participation in another interventional clinical trial, or receipt of other investigational drugs/devices within 4 weeks prior to the first dose; 4.Major surgical procedures (e.g., craniotomy, thoracotomy, laparotomy) within 4 weeks prior to enrollment or anticipated need for major surgery during the study; 5.History of allogeneic organ transplantation (except corneal transplants) or hematopoietic stem cell transplantation; 6.Failure to recover from prior therapy-related toxicities/complications (i.e., CTCAE grade =grade II heart block, ventricular arrhythmias, atrial fibrillation); b. Unstable angina, congestive heart failure (CHF), or chronic heart failure with NYHA class >=2; c. Arterial thromboembolic events (e.g., myocardial infarction, unstable angina, stroke, transient ischemic attack) within 6 months prior to enrollment; d. History of non-infectious pneumonitis requiring glucocorticoids within 1 year, or active interstitial lung disease; e. Active tuberculosis; f. Active infection requiring systemic therapy; g. Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; h. Liver diseases (e.g., cirrhosis, decompensated liver disease, acute/chronic active hepatitis); i. Poorly controlled diabetes (fasting blood glucose >10 mmol/L); j. Psychiatric disorders impairing compliance; k. Symptomatic central nervous system metastases and/or carcinomatous meningitis; 9.Any condition (e.g., medical history, abnormal lab values, concurrent treatments) that may interfere with study results, compromise protocol adherence, or pose additional risks as judged by the investigator. 10.Patients with: a. Uncontrolled hypertension; b. Central nervous system metastases; c. Persistent clinically significant toxicities from prior cancer therapy; d. Active hepatitis B/C or HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;Progression Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed