About this trial
A Single-Arm, Non-Randomized, Open-Label Phase 2 Study of Nab-Sirolimus in Patients with Progressive or Symptomatic Epithelioid Hemangioendothelioma.
Detailed Description: Avoid duplicating information that will be entered or uploaded elsewhere in the record.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN).
Disqualifiers
Nitrosoureas (e.g., carmustine, lomustine) or mitomycin C: within 6 weeks prior to the first dose of study drug;
Oral fluoropyrimidines and small-molecule targeted agents: within 2 weeks prior to the first dose of study drug or within 5 known half-lives of the drug, whichever is longer;
Traditional Chinese medicines with anti-tumor indications: within 2 weeks prior to the first dose of study drug.
Received any other unapproved investigational product within 4 weeks prior to the first dose of study drug.
Trial design
Single group
Treatments tested in this trial
Sirolimus for injection (Albumin-bound)
DrugSirolimus for injection (Albumin-bound) will be administered intravenously on day 1and day 8 every 21 days (a cycle).
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate (ORR)
The percentage of patients who achieved a confirmed overall response of PR or CR assessed by RECIST V1.1.
Secondary outcomes
Disease Control Rate (DCR)
The percentage of patients with confirmed complete response (CR), partial response (PR), or stable disease (SD) lasting ≥ 4 weeks from baseline
Duration of Response (DOR)
The time from the start of CR or PR to the first date of documented PD or death
Progression-free Survival (PFS)
The time from the first dose to the first documented disease progression or death from any cause, which occurs first.
Overall survival (OS)
The time from the first dose to death from any cause.
Sponsors and contacts
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