Bone and soft tissue sarcoma
Conditions
Interventions
none:none
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Age 8-50, gender unlimited. 2. Advanced bone and soft tissue sarcoma confirmed by histopathology.Local tumors and isolated lung lesions must be confirmed by pathological diagnosis, and multiple lung metastases do not need pathological examination. Advanced bone and soft tissue sarcoma Definition: (1) The primary tumor or locally recurrent tumor cannot be cured or the patient refuses amputation despite the possibility of amputation. (2) Bone and soft tissue sarcomas with distant metastases cannot be radically cured by surgery or other local treatments (e.g., stereotactic radiosurgery, argon-helium knife, ultrasound focusing knife, etc.). (3) Whether the tumor is primary or metastatic, the patient refuses or cannot tolerate surgery or other local treatment. (4) Multiple pulmonary metastases with measurable lesions, but not with the following conditions: a. Non-stable intracranial metastasis b. Multiple pelvic metastases c. Tumor thrombus formation of large vessels (femoral vessels, iliac vessels, abdominal vessels, axillary vessels, subclavian vessels) d. accompanied by body cavity effusion 3. First-line chemotherapy for bone and soft tissue sarcomas (anthracycline-containing regiments) was unsuccessful. 4. Patients with disease progression within 6 months after the end of first-line chemotherapy with neoadjuvant or adjuvant chemotherapy, and patients with disease progression over 6 months need to obtain consent from the subject himself or his legal representative. 5. Measurable lesions at baseline as per RECIST version 1.1. 6. The ECOG physical status score is 0-1, and the expected survival period is more than 3 months. 7. Recovery from previous treatment: According to NCI-CTC AE 4.0, all side effects (except hair loss) resolved to grade 1 or below. 8. The following peripheral blood imaging and blood biochemical indicators suggest appropriate organ function: Hemoglobin (Hb) = 90g/L, Neutrophil (ANC) =1.5×109/L, Platelet count (Plt) = 80×109/L, Serum creatinine (Cr) = 1.5× upper limit of normal (ULN), blood urea nitrogen (BUN) = 2.5× upper limit of normal (ULN); Total bilirubin (TB) = ULN; Alkaline phosphatase (ALP) = 2.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5×ULN; Albumin (ALB) = 25 g/L. 9. Pregnancy test (urine beta-HCG) negative (for women of childbearing age who have sex). 10. Sign informed consent forms (or signed by legal representatives) to demonstrate that they understand the purpose of the study and the procedures required by the study, and are willing to participate in the study.Subjects under the age of 18 should sign a minor informed consent form.
Exclusion criteria
Exclusion criteria: Potential participants who meet any of the following criteria must be excluded from the study: 1. Within 3 weeks after the last systemic cytotoxic drug therapy, radiation therapy or any experimental drug therapy. 2. 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 1 cervical cancer. 3. Active central nervous system metastasis. 4. Myocardial infarction, New York Heart Society Class II or above heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram evidence of acute ischemia or active conduction system abnormalities within the 6 months prior to enrollment. 5. Uncontrolled comorbidities, including but not limited to: poorly controlled hypertension or diabetes, persistent active infections, or mental illness or social conditions that may affect participants' compliance with the study. 6. Pregnancy or lactation. 7. Any condition which, in the opinion of the investigator, is likely to harm the subject or cause the subject to be unable to meet or perform the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate;Disease control rate;Duration of Response;progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactHaiyan Hu
Shanghai Sixth People's Hospital
Outcome results
None listed