Epithelioid HemangioendotheliomaPhase 2NCT07684287
A Phase 2 Study of Sirolimus for Injection (Albumin-bound) in Patients With Progressive or Symptomatic Epithelioid Hemangioendothelioma
A Phase 2 study testing Sirolimus for injection (Albumin-bound) in people with Epithelioid Hemangioendothelioma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epithelioid Hemangioendothelioma
- What is being tested?
- Sirolimus for injection (Albumin-bound)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 30 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.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.
- [Referencing the 2021 ESMO Expert Consensus for investigator judgment: Patients with serous cavity effusion and/or obvious systemic symptoms shall initiate systemic therapy as early as possible. Patients with metastatic disease accompanied by documented disease progression, aggravated symptoms and/or organ dysfunction are eligible for systemic therapy.] 2.At least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- 3.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:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L.
- Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN).
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- Hepatic function:
- Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with liver metastasis, biliary obstruction or confirmed Gilbert's syndrome); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis).
- Coagulation function:
- International normalized ratio (INR) and prothrombin time (PT) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. 6.Fasting serum triglycerides < 300 mg/dL (3.42 mmol/L); fasting serum cholesterol < 350 mg/dL (9.07 mmol/L).
- 7.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.
- 9.Participants must be fully informed of the study prior to trial participation and voluntarily sign the written informed consent form (ICF).
Who cannot join
- 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:
- 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.
- 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.
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- 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.
- Have a history of severe cardiovascular diseases, including severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block); myocardial infarction, unstable angina, heart failure, NYHA Class II or higher heart failure, or a history of coronary artery bypass grafting within 6 months prior to the first dose; left ventricular ejection fraction (LVEF) < 50% at screening; QTcF > 450 msec in male participants or QTcF > 470 msec in female participants.
- Adverse events from prior anti-tumor therapies have not recovered to Grade ≤ 1 per CTCAE Version 6.0 (alopecia and other toxicities judged by the investigator to pose no safety risk are excluded).
- Have clinically symptomatic central nervous system (CNS) metastases or leptomeningeal metastases, or have evidence of uncontrolled CNS/leptomeningeal metastases, and are deemed ineligible for enrollment by the investigator.
- Have uncontrolled serous cavity effusions (e.g., pleural effusion, ascites, pericardial effusion) requiring frequent drainage or medical intervention within 14 days prior to the first dose. Additional intervention needed within 2 weeks after prior management is not allowed (excluding cytological examination of effusion samples).
- Currently have interstitial lung disease / non-infectious pneumonia requiring intervention, or interstitial lung disease cannot be ruled out by imaging examinations at screening.
- Have known hypersensitivity or intolerance to any component of the study drug or its excipients.
- Have a history of autoimmune diseases (excluding tuberous sclerosis), immunodeficiency diseases including positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
- Have active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection or active syphilis infection.
- Active HBV infection: Hepatitis B surface antigen (HBsAg) positive with HBV-DNA titer ≥ 1 × 10³ IU/mL. Participants with positive HBsAg and peripheral blood HBV-DNA < 1 × 10³ IU/mL may be enrolled if the investigator confirms chronic hepatitis B is stable and will not increase participant risks.
- Active HCV infection: Anti-HCV positive and HCV RNA positive.
- Active syphilis infection: Positive syphilis serology (RPR or TRUST) or syphilis infection requiring systemic treatment.
- Have concomitant diseases that may seriously compromise participant safety or interfere with study completion (e.g., uncontrolled hypertension and/or hyperglycemia, active gastrointestinal bleeding), or are otherwise considered ineligible for this trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Liqun Jia, PhD, +86-010-84206086, liqun-jia@hotmail.com
About this study
Official title: A Single-Arm, Non-Randomized, Open-Label Phase 2 Study of Nab-Sirolimus in Patients With Progressive or Symptomatic Epithelioid Hemangioendothelioma
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.
Read the detailed description
This is a non-randomized, open label, single arm Phase 2 trial with histologically-confirmed progressive and/or symptomatic epithelioid hemangioendothelioma requiring systemic treatment. Nab-sirolimus 100 mg/m2 will be administered as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle. The primary objective is to determine ORR evaluated by investigator based on RECIST V1.1 of nab-sirolimus in patients with EHE who require systemic treatment.
- Conditions
- Epithelioid Hemangioendothelioma
- Being tested
- Sirolimus for injection (Albumin-bound)
- Medical subject headings
- Hemangioendothelioma, Epithelioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus for injection (Albumin-bound)Drug
Sirolimus for injection (Albumin-bound) will be administered intravenously on day 1and day 8 every 21 days (a cycle).
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Sirolimus for injection (Albumin-bound) will be administered intravenously on day 1and day 8 every 21 days (a cycle). Receives: Drug: Sirolimus for injection (Albumin-bound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The percentage of patients who achieved a confirmed overall response of PR or CR assessed by RECIST V1.1.
Measured: 2 years
Secondary outcomes (4)
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
Measured: 2 years
Duration of Response (DOR)
The time from the start of CR or PR to the first date of documented PD or death
Measured: 2years
Progression-free Survival (PFS)
The time from the first dose to the first documented disease progression or death from any cause, which occurs first.
Measured: 2years
Overall survival (OS)
The time from the first dose to death from any cause.
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelioid HemangioendotheliomaStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684287
- Sponsor's protocol ID
- HB1901-014
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Non-Randomized, Open-Label Phase 2 Study of Nab-Sirolimus in Patients With Progressive or Symptomatic Epithelioid Hemangioendothelioma
- ClinicalTrials.gov ID
- NCT07684287
- Acronym / sponsor ID
- HB1901-014
- Conditions
- Epithelioid Hemangioendothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a non-randomized, open label, single arm Phase 2 trial with histologically-confirmed progressive and/or symptomatic epithelioid hemangioendothelioma requiring systemic treatment. Nab-sirolimus 100 mg/m2 will be administered as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle. The primary objective is to determine ORR evaluated by investigator based on RECIST V1.1 of nab-sirolimus in patients with EHE who require systemic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Sirolimus for injection (Albumin-bound)Sirolimus for injection (Albumin-bound) will be administered intravenously on day 1and day 8 every 21 days (a cycle). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1.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.
- [Referencing the 2021 ESMO Expert Consensus for investigator judgment: Patients with serous cavity effusion and/or obvious systemic symptoms shall initiate systemic therapy as early as possible. Patients with metastatic disease accompanied by documented disease progression, aggravated symptoms and/or organ dysfunction are eligible for systemic therapy.] 2.At least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- 3.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:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L.
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirolimus for injection (Albumin-bound)Sirolimus for injection (Albumin-bound) will be administered intravenously on day 1and day 8 every 21 days (a cycle). | Drug | single arm |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years
The percentage of patients who achieved a confirmed overall response of PR or CR assessed by RECIST V1.1.
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: 2 years
Duration of Response (DOR)
Time frame: 2years
Progression-free Survival (PFS)
Time frame: 2years
Overall survival (OS)
Time frame: 2years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sirolimus for injection (Albumin-bound) in people with Epithelioid Hemangioendothelioma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Information Team Officer (+86-311 6908 5587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.