Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma

Last updated: May 19, 2025
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Terminated

Phase

1/2

Condition

Hemangioma

Treatment

Propranolol Hydrochloride

Clinical Study ID

NCT03633747
SAHZJU-Y2018-059
  • Ages 18-65
  • All Genders

Study Summary

Hepatic hemangioma is one of the most common benign tumor of the liver. Although the overall prognosis is good, active interventions are still needed in high-risk patients. Without specific drugs, the main treatment methods include surgical treatments, interventional therapies and radiotherapies. Effective medical treatments are needed urgently. Propranolol has achieved good results in infantile Facial/hepatic hemangioma, and shows some effectiveness in adult hemangioma. Here, investigators intend to evaluate the therapeutic effect of propranolol in adult hepatic hemangioma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 to 65 years of age.

  • Hemangioma with a diameter of 5-10 cm, no clinical symptoms, no obvious risk ofhemangioma rupture and bleeding, no obvious symptoms of tumor compression, andexcluding malignant diseases; or hemangioma without surgical indications but have astrong willingness to treat; compliance with treatment indications, but refusesurgical, interventional or radiotherapy radiative interventions.

  • No other beta receptor modulators (activation or blockade of beta receptorsignaling) were given during the previous six months.

  • Eastern Cooperative Oncology Group score 0-2 points.

Exclusion

Exclusion Criteria:

  • Liver lesions with other malignant tumors or hepatic hemangiomas are not clearlydiagnosed or have other undefined features.

  • Hepatic hemangioma requires surgical or radiological intervention within a limitedperiod of time, otherwise there may be a greater risk.

  • Beta receptor modulator therapy is required for cardiovascular and other diseaseswithin six months.

  • Previous cardiovascular or cerebrovascular events or with high risk ofcardiovascular and cerebrovascular events.

  • Suffering from severe liver diseases such as severe cirrhosis, hepatic adenoma,liver dysfunction and so on.

  • Post liver transplantation.

  • Heart rate < 60 beats/min, blood pressure < 100/60 mmHg, orthostatic hypotension,cardiac insufficiency or severe cardiovascular disease (moderate to severehypertension, coronary atherosclerotic heart disease, severe or acute heart failure,II-III atrioventricular block, ventricular tachycardia, cardiogenic shock, Raynaudsyndrome or other peripheral vascular diseases).

  • Severe pulmonary diseases (such as bronchial asthma, emphysema), severehematological diseases (such as agranulocytosis, thrombocytopenia), severe mentaldisorders (such as depression), severe thyroid diseases (hypothyroidism, hormonereplacement therapy after thyroidectomy), diabetes mellitus need to be controlled bydrugs. Severe kidney disease (such as nephrotic syndrome, glomerulonephritis, renalinsufficiency).

  • Others: history of drug allergy, pregnancy or breast-feeding, other malignant tumorsin the past five years.

Study Design

Total Participants: 8
Treatment Group(s): 1
Primary Treatment: Propranolol Hydrochloride
Phase: 1/2
Study Start date:
July 01, 2018
Estimated Completion Date:
December 31, 2021

Study Description

In view of the lack of medical treatment for hepatic hemangioma, investigators chose hemangioma patients with a diameter of 5-10 cm and no significant risk of rupture, or those with surgical indications but rejected of surgical, interventional/radiological interventions. After confirmation of no high risk for drugs, oral propranolol was given. The tumor size, objective remission rate, disease control rate, drugs related side effects and other endpoints events were recorded and analyzed, to assess the propranolol could or couldn't effectively control the progress of hepatic hemangioma.

Connect with a study center

  • The second affiliated hospital of Zhejiang University

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

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