Angiosarcoma
Conditions
Interventions
Intervention group:Nab-paclitaxel plus Gemcitabine and Anlotinib
Sponsors
Zhongshan Hospital,Fudan University
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Inclusion criteria
Inclusion criteria: Potential subjects must meet all of the following criteria to be enrolled in this study: 1. Age >=16 years and =3 months; 4. Histologically confirmed metastatic or locally advanced unresectable angiosarcoma; special vascular-related sarcoma subtypes such as Kaposi sarcoma and epithelioid hemangioendothelioma may be enrolled at the investigator's discretion; 5. Subjects must enter the study during first-line standard therapy and be assessed by the investigator as suitable for the current study regimen; failure of second-line or subsequent therapy is also acceptable for enrollment. Subjects must not have received prior anti-angiogenic targeted therapy during the palliative treatment phase (prior anti-angiogenic targeted therapy in the adjuvant setting is not an exclusion criterion; relapse occurring more than 6 months after completion of adjuvant therapy is acceptable), must not have received prior gemcitabine, and must not have received prior nab-paclitaxel (prior treatment with conventional paclitaxel is not an exclusion criterion). Disease progression occurring during or within 6 months after completion of neoadjuvant/adjuvant therapy is considered failure of first-line standard therapy; or intolerable toxicity from prior therapy; 6. At least one measurable lesion >=1 cm in diameter; 7. Adequate major organ function meeting the following criteria within 7 days prior to treatment: (1) Hematologic parameters (without transfusion of blood or blood products, and without use of G-CSF or other hematopoietic growth factors for correction within 14 days): a) Hemoglobin (Hb) >=90 g/L; b) Absolute neutrophil count (ANC) >=1.5×10^9/L; c) Platelet count (PLT) >=75×10^9/L; (2) Biochemical parameters: a) Total bilirubin (TBIL) =60 mL/min; (3) Urine protein =2+, 24-hour urine protein quantification must be = lower limit of normal (LLN); (6) Thyroid function: Thyroid-stimulating hormone (TSH) <= ULN; if abnormal, free triiodothyronine (T3) and free thyroxine (T4) levels should be considered, and subjects with normal T3 and T4 levels may be enrolled; 8. Women of childbearing potential must use a highly effective method of contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and must agree to use an appropriate method of contraception during the study and for 8 weeks after the last dose of study drug, or must be surgically sterile. For men, agreement to use an appropriate method of contraception during the study and for 8 weeks after the last dose of study drug, or surgical sterilization, is required; 9. Provision of signed informed consent by the subject with good compliance (for minors aged 16-18 years, signed informed consent must be obtained from parents or legally authorized representatives).
Exclusion criteria
Exclusion criteria: Potential subjects meeting any of the following criteria must be excluded from this study: 1. Receipt of antineoplastic therapy within 3 weeks prior to enrollment, including radiotherapy, surgery, palliative chemotherapy, or other molecular targeted therapy, or still within 5 half-lives of prior agents; 2. Prior exposure to anti-angiogenic agents as part of palliative treatment regimens, including but not limited to anlotinib, surufatinib, lenvatinib, sunitinib, sorafenib, regorafenib, bevacizumab, or apatinib; 3. Planned surgical intervention or radiotherapy during the study period; 4. Central nervous system (CNS) metastases with inadequate disease control as determined by imaging; well-controlled CNS metastases are permitted; 5. Use of immunosuppressive agents within 14 days prior to enrollment, including dexamethasone >10 mg/day; 6. History of any active autoimmune or immune-mediated disease, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Active or uncontrolled severe infection (>=CTCAE Grade 2) within 4 weeks prior to enrollment; 8. History of hypertension inadequately controlled despite antihypertensive therapy (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 9. Clinically significant hemorrhagic symptoms within 3 months prior to enrollment, or documented bleeding diathesis, or thromboembolic events within 12 months (including stroke and/or transient ischemic attack); 10. Persistent toxicity from prior antineoplastic therapy not resolved to CTCAE v5.0 Grade Grade I, arrhythmia (including QTc >=480 ms), or >=Grade 2 congestive heart failure (New York Heart Association [NYHA] functional classification) within 6 months prior to enrollment; 12. Diagnosis of other malignancies within 3 years prior to enrollment; 13. HIV positivity, cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral therapy; 14. Participation in other antineoplastic drug clinical trials within 3 weeks prior to enrollment; 15. History of psychoactive substance abuse with inability to abstain, or psychiatric disorders; 16. Any condition affecting drug absorption, or inability to take anlotinib orally; 17. Any concomitant disease or other condition that, in the investigator's opinion, would substantially compromise patient safety, confound study results, or interfere with study completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Countries
China
Contacts
Public ContactZhou.yuhong, Guo.xi
Fenglin Road 180#,Shanghai,China
Outcome results
None listed