A Phase 2 Study of Sirolimus for Injection (Albumin-bound) in Patients With Progressive or Symptomatic Epithelioid Hemangioendothelioma

NCT07684287 | Not Yet Recruiting Phase 2

• 1 other identifier: HB1901-014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epithelioid Hemangioendothelioma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The percentage of patients who achieved a confirmed overall response of PR or CR assessed by RECIST V1.1.

  2 years

Secondary Outcomes (4)

• Disease Control Rate (DCR)

  2 years

• Duration of Response (DOR)

  2years

• Progression-free Survival (PFS)

  2years

• Overall survival (OS)

  2years

Study Arms (1)

single arm

EXPERIMENTAL

Sirolimus for injection (Albumin-bound) will be administered intravenously on day 1and day 8 every 21 days (a cycle).

Drug: Sirolimus for injection (Albumin-bound)

Interventions

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).

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).
• 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).
• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Hemangioendothelioma, Epithelioid

Interventions

Sirolimus; Injections

Condition Hierarchy (Ancestors)

Hemangioendothelioma; Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Clinical Trial Information Team Officer

CONTACT

+86-311 6908 5587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

CN (1)