A Phase 2 Study of Sirolimus for Injection (Albumin-bound) in Patients With Progressive or Sympto… (NCT07684287) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase 2 Study of Sirolimus for Injection (Albumin-bound) in Patients With Progressive or Symptomatic Epithelioid Hemangioendothelioma
China40 participantsStarted 2026-08-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.Aged ≥ 18 years old; Histologically confirmed progressive or symptomatic epithelioid hemangioendothelioma (EHE) unsuitable for curative surgery, and deemed by the investigator to require systemic therapy.
.Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2. 4.Estimated survival time \> 3 months. 5.Adequate major organ function prior to treatment (no blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or similar agents administered within 14 days before screening tests), meeting the following criteria:
. Hematology:
. Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN).
. Hepatic function:
. Coagulation function:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
.Glycated hemoglobin (HbA1c) \< 8%. 8.Participants of childbearing potential (female or male partners with female partners of childbearing potential) and participants with non-surgical sterilization must use effective contraception \[e.g., intrauterine device (IUD), oral contraceptives, condoms\] throughout the study treatment period and for 6 months after the end of study treatment. Females of childbearing potential without surgical sterilization must have a negative serum pregnancy test within 7 days prior to enrollment and shall not be breastfeeding.
.Participants must be fully informed of the study prior to trial participation and voluntarily sign the written informed consent form (ICF).
Exclusion criteria
. Received any anti-tumor therapies including mTOR inhibitors (e.g., sirolimus, everolimus), chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy and immunotherapy within 4 weeks prior to the first dose of study drug, except for the following:
. Received any other unapproved investigational product within 4 weeks prior to the first dose of study drug.
. Underwent major surgical procedures within 4 weeks prior to the first dose of study drug, or have not fully recovered from any previous invasive procedures.
. Received systemic glucocorticoids (prednisone \> 10 mg/day or equivalent dose of similar agents) or other immunosuppressants within 2 weeks prior to the first dose of study drug. Exceptions: topical, ophthalmic, intra-articular, intranasal and inhaled glucocorticoids; short-term glucocorticoid use for prophylaxis (e.g., prevention of contrast medium allergy).
. Had an infection requiring systemic (oral or intravenous) anti-infective therapy within 2 weeks prior to enrollment (uncomplicated urinary tract infection or upper respiratory tract infection is excluded).
. Received live vaccines, live attenuated vaccines or COVID-19 vaccines within 4 weeks prior to the first dose of study drug.
. Used strong inhibitors or inducers of hepatic metabolic enzyme CYP3A4 within 2 weeks prior to the first dose of study drug, or continued to take such agents.
. Have a history of other malignant tumors within 5 years prior to enrollment, except for: cured basal cell carcinoma, squamous cell skin carcinoma, superficial bladder cancer, in situ prostate cancer, cervical carcinoma in situ, breast carcinoma in situ, or other locally curable cancers with continuous disease-free survival for 5 years.