A Study of Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Patients With Advanc… (NCT05625919) | Clinical Trial Compass
UnknownPhase 1/2
A Study of Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumor (PEComa)
China54 participantsStarted 2022-11-08
Plain-language summary
This is a phase â… b/â…¡ multi-center study of safety and efficacy of Sirolimus for Injection (Albumin-bound) in patients with advanced malignant perivascular epithelioid cell tumor (PEComa).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Aged 18 years or older, and Phase â… b: Patients with histologically confirmed diagnosis of advanced soft tissue sarcomas (including malignant PEComa, accounting for at least 1/2) have failed standard treatment (disease progression or relapse or intolerance to chemotherapy, radiotherapy, targeted therapy, etc.) or lack effective treatment; Phase â…¡: Patients must have a histologically confirmed diagnosis of malignant PEComa that is either metastatic or locally advanced and for which surgery is not a recommended option.
\[Malignant PEComas displaying 2 or more of the features of large size (\> 5 cm), infiltrative growth, high nuclear grade, cellular necrosis, mitoses ≥1/50 high power field (HPF), or vascular invasion\]
* At least 1 measurable lesion as defined by RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Life expectancy \>3 months.
* Patient must have the following biological parameters levels at screening (without blood transfusion, EPO, G-CSF and other medical support within14 days prior to screening tests):
Blood tests: Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L; Platelet count ≥100 × 10\^9/L; Hemoglobin ≥90 g/L; Renal function tests: serum creatinine ≤1.5 x upper limit of normal (ULN); Liver function tests: Total bilirubin ≤1.5 x ULN (Patients with liver metastases, bile duct obstruction, or confirmed Gilbert syndrome: ≤ 3×ULN); AST and ALT ≤2.5 x ULN (≤5 x ULN if attributable to liver metastases); Blood…