Osteosarcoma and soft tissue sarcoma
Conditions
Interventions
Experimental group:surufatinib combined with standard chemotherapy
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Fully understand the study and voluntarily sign the informed consent form; 2.Aged >= 18 years and 1 year for osteosarcoma and >6 months for soft tissue sarcoma); 5.At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (lesion length >= 10 mm on CT or MRI scan, or lymph node short axis >= 15 mm); 6.>= 2 weeks between the end of palliative treatment (including radiotherapy) for local lesions (non-target lesions) and study enrollment; 7.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (or 2 for patients with limb tumors); 8.Expected survival >= 3 months; 9.Hematological tests (without transfusion or hematopoietic growth factor support within 14 days):Hemoglobin (Hb) >= 90.0 g/L; Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelet (PLT) count >= 100×10^9/L; White blood cell (WBC) count >= 3.0×10^9/L; 10.Blood biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 50 mL/min; 11.Urinalysis shows urine protein = 2+, a 24-hour urine collection must demonstrate 24-hour urine protein = 50%; 14.Women of childbearing potential must agree to use contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after study completion; serum pregnancy test must be negative within 7 days before enrollment, and the patient must be non-lactating. Male patients must agree to use contraception during the study and for 6 months after study completion.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity or allergy to the investigational drug, its analogs, or any of its excipients. 2.History or concurrent diagnosis of any other malignancy within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, melanoma in situ, or carcinoma in situ of the cervix. 3.Received any anticancer therapy within 4 weeks prior to the start of study treatment, including but not limited to chemotherapy, radical radiotherapy, targeted therapy, immunotherapy, traditional Chinese medicine with antitumor effects, transarterial chemoembolization (TACE), cryoablation, or radiofrequency ablation. 4.Received palliative radiotherapy for bone metastases within 2 weeks prior to the start of study treatment. 5.Use of St. John’s Wort within 3 weeks before the first dose of study treatment, or use of strong CYP3A4 inducers or inhibitors within 2 weeks before the first dose (see Appendix 4). 6.Any clinically significant active infection, including but not limited to human immunodeficiency virus (HIV) infection. 7.Concurrent participation in another interventional clinical trial, unless participating in an observational (non-interventional) study or in the follow-up phase of an interventional study. 8.Uncontrolled hypertension at screening, defined as systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; or a history of hypertensive crisis or hypertensive encephalopathy. 9.Major surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose. 10.Active gastric or duodenal ulcers, ulcerative colitis, intestinal obstruction, other gastrointestinal disorders, or unresected tumors with active bleeding, or any condition deemed by the investigator to increase the risk of gastrointestinal bleeding or perforation; or a history of intestinal perforation or fistula with incomplete surgical recovery. 11.History of significant bleeding (>30 mL within the past 3 months), hemoptysis (>5 mL within the past 4 weeks), or thromboembolic events (including transient ischemic attacks) within the past 12 months. 12.Severe cardiovascular or cerebrovascular disease history, including but not limited to: Myocardial infarction or cerebral hemorrhage; Arterial/venous thromboembolic events within the past 6 months without proper treatment (e.g., cerebrovascular accident [including transient ischemic attack], deep vein thrombosis, pulmonary embolism); Severe cardiovascular or cerebrovascular events within the past 6 months (e.g., acute coronary syndrome, congestive heart failure [NYHA Class II-IV], ischemic stroke [excluding lacunar infarction], aortic dissection); Clinically significant arrhythmias or ECG abnormalities (e.g., frequent ventricular premature contractions [=10% on 24-hour Holter], ventricular tachycardia, second- or third-degree atrioventricular block, sick sinus syndrome); Any factors that increase the risk of QTc prolongation or arrhythmia (e.g., heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative <40 years old, or concomitant use of QT-prolonging medications). 13.Adverse reactions from prior anticancer therapy have not recovered to = Grade 1 (except for toxicities such as alopecia, which the investigator deems non-hazardous). 14.Dysphagia or known malabsorption syndrome affecting drug absorption. 15.Known central nervous system (CNS) metastases or leptomeningeal meta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Adverse event;Disease Control Rate (DCR);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactFuxiang Zhou
Zhongnan Hospital of Wuhan University
Outcome results
None listed