Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma

NCT03633747 | Terminated Phase 1

• 1 other identifier: SAHZJU-Y2018-059
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemangioma Liver

Keywords

hepatic hemangioma; propranolol

Outcome Measures

Primary Outcomes (1)

• Tumor size

  Evaluating maximum diameter obtained by contrast-enhanced CT scanning

  6 months after treatment

Secondary Outcomes (1)

• Objective response rate

  6 months after treatment

Other Outcomes (3)

• Disease control rate

  6 months after treatment

• Vascular endothelial growth factor

  6 months after treatment

• Common Toxicity Criteria for Adverse Effects

  6 months after treatment

Study Arms (1)

propranolol

EXPERIMENTAL

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

Interventions

Propranolol Hydrochloride DRUG

Oral propranolol hydrochloride tablets are administration for 6 months at dose of 1.5 mg/kg or the maximum dose tolerable.

propranolol

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Interventions

Propranolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 16, 2018
• Study Start: July 1, 2018
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2021
• Last Updated: May 22, 2025

Record last verified: 2018-08

Locations

CN (1)