Ewing's sarcoma
Conditions
Interventions
Group A:Irinotecan + Temozolomide (Irinotecan 50mg/m^2 d1-d5 IV infusion + Temozolomide 100mg/m^2 d1-d5 PO)
Group B:Liposomal Irinotecan + Paclitaxel Micelles (Liposomal Irinotecan 60 mg/m^x d1, d15 + Paclitaxel Micelles 150 mg/m^x d1, d15)
Group C:Liposomal Irinotecan + Paclitaxel Micelles + Dacomitinib (Liposomal Irinotecan 60 mg/m^x d1, d15 + Paclitaxel Micelles 150 mg/m^x d1, d15 + Dacomitinib 30 mg orally, daily)
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Ages 8–50, no gender restriction. 2. Progressive Ewing's sarcoma confirmed by histopathology. Local tumors and solitary lung lesions must be pathologically confirmed, while multiple lung metastases do not require pathological examination. 3. Definition of progressive Ewing's sarcoma: (1) Primary or locally recurrent tumors that cannot be cured, or patients refuse amputation even though cure could be achieved through it. (2) Bone and soft tissue sarcomas with distant metastases, where metastatic tumors cannot be cured by surgery or other local treatment methods (e.g., stereotactic radiosurgery, argon-helium knife, high-intensity focused ultrasound, etc.). (3) Whether primary or metastatic, the patient refuses or cannot tolerate surgery or other local treatments. (4) Multiple lung metastases with measurable lesions, excluding the following conditions: 1) Unstable intracranial metastases; 2) Multiple pelvic metastases; 3) Tumor thrombus in major blood vessels (femoral, iliac, abdominal, axillary, subclavian vessels); 4) Presence of body cavity effusion. 4. Patients who have failed first-line chemotherapy for Ewing's sarcoma (including anthracycline-based regimens). 5. Disease progression within 6 months after first-line neoadjuvant or adjuvant chemotherapy. For progression beyond 6 months, consent must be obtained from the subject or their legal guardian. 6. Measurable lesions must be present at baseline according to RECIST 1.1 criteria. 7. ECOG performance status of 0–1, with an expected survival of over 3 months. 8. Recovery from prior treatments: According to NCI-CTC AE version 4.0, all adverse events (except alopecia) must have resolved to grade 1 or lower. 9. Peripheral blood and biochemical indicators showing adequate organ function: Hemoglobin (Hb) >= 90 g/L, absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count (Plt) >= 80 x 10^9/L, serum creatinine (Cr) = 25 g/L. 10. Negative pregnancy test (urine ß-HCG) for women of childbearing age who are sexually active. 11. Signing of informed consent (or by legal guardian) to confirm that they understand the purpose of this study and the required procedures, and are willing to participate. Subjects under 18 must sign the informed consent form for minors.
Exclusion criteria
Exclusion criteria: Potential subjects meeting any of the following criteria must be excluded from the study: 1. Within 3 weeks after the last treatment with systemic cytotoxic drugs, radiotherapy, or any investigational drug. 2. History of other malignant tumors within the past 3 years. Exceptions: basal cell carcinoma of the skin or non-metastatic squamous cell carcinoma, carcinoma in situ of the cervix, or FIGO stage I cervical cancer. 3. Active central nervous system metastases. 4. Myocardial infarction, New York Heart Association class II or higher heart failure, uncontrolled angina, uncontrolled serious ventricular arrhythmias, clinically significant pericardial disease, or ECG indicating acute ischemia or active conduction system abnormalities within 6 months prior to enrollment. 5. Uncontrolled comorbidities, including but not limited to poorly controlled hypertension or diabetes, persistent active infection, or psychiatric or social conditions that may affect the subject’s compliance with the study. 6. Pregnancy or breastfeeding. 7. Any condition that the investigator believes may harm the subject or prevent the subject from fulfilling or complying with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mPFS, Median Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR,Objective Response Rate;DCR,Disease Control Rate;OS,Overall survival;Quality of Life Score; | — |
Countries
China
Contacts
Public ContactHu Haiyan
Shanghai Sixth People's Hospital
Outcome results
None listed