Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma

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.

Study Overview

• Status: Recruiting
• Conditions: Hemangioma Liver
• Intervention / Treatment: Drug: Propranolol Hydrochloride

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 to 65 years of age.
• Hemangioma with a diameter of 5-10 cm, no clinical symptoms, no obvious risk of hemangioma rupture and bleeding, no obvious symptoms of tumor compression, and excluding malignant diseases; or hemangioma without surgical indications but have a strong willingness to treat; compliance with treatment indications, but refuse surgical, interventional or radiotherapy radiative interventions.
• No other beta receptor modulators (activation or blockade of beta receptor signaling) were given during the previous six months.
• Eastern Cooperative Oncology Group score 0-2 points.

Exclusion Criteria:

• Liver lesions with other malignant tumors or hepatic hemangiomas are not clearly diagnosed or have other undefined features.
• Hepatic hemangioma requires surgical or radiological intervention within a limited period of time, otherwise there may be a greater risk.
• Beta receptor modulator therapy is required for cardiovascular and other diseases within six months.
• Previous cardiovascular or cerebrovascular events or with high risk of cardiovascular 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 severe hypertension, coronary atherosclerotic heart disease, severe or acute heart failure, II-III atrioventricular block, ventricular tachycardia, cardiogenic shock, Raynaud syndrome or other peripheral vascular diseases).
• Severe pulmonary diseases (such as bronchial asthma, emphysema), severe hematological diseases (such as agranulocytosis, thrombocytopenia), severe mental disorders (such as depression), severe thyroid diseases (hypothyroidism, hormone replacement therapy after thyroidectomy), diabetes mellitus need to be controlled by drugs. Severe kidney disease (such as nephrotic syndrome, glomerulonephritis, renal insufficiency).
• Others: history of drug allergy, pregnancy or breast-feeding, other malignant tumors in the past five years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: propranolol; Propranolol hydrochloride tablets were taken orally three times a day at an initial dose of 30 mg/day, doubled one week later until the daily dose was 1.5 mg/kg. If the dose was unable to increase due to side effects, the maximum dose tolerable was maintained for 6 months.	Drug: Propranolol Hydrochloride; Oral propranolol hydrochloride tablets are administration for 6 months at dose of 1.5 mg/kg or the maximum dose tolerable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor size	Evaluating maximum diameter obtained by contrast-enhanced CT scanning	6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	Percentage of patients whose cancer shrinks or disappears after treatment	6 months after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate	Percentage of patients whose cancer doesn't progress after treatment	6 months after treatment
Vascular endothelial growth factor	Level of serum Vascular endothelial growth factor	6 months after treatment
Common Toxicity Criteria for Adverse Effects	According to Common Toxicity Criteria for Adverse Effects version 4	6 months after treatment

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: propranolol; hepatic hemangioma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Hemangioma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: SAHZJU-Y2018-059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No