Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma

Hemangioma Liver Clinical Trial

Official title:

Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03633747
• Other study ID #: SAHZJU-Y2018-059
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2018
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Tingbo Liang, MD PhD
• Phone: 8613666676128
• Email: liangtingbo[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma Liver

Intervention

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

Locations

Country	Name	City	State
China	The second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease control rate	Percentage of patients whose cancer doesn't progress after treatment	6 months after treatment
Other	Vascular endothelial growth factor	Level of serum Vascular endothelial growth factor	6 months after treatment
Other	Common Toxicity Criteria for Adverse Effects	According to Common Toxicity Criteria for Adverse Effects version 4	6 months after treatment
Primary	Tumor size	Evaluating maximum diameter obtained by contrast-enhanced CT scanning	6 months after treatment
Secondary	Objective response rate	Percentage of patients whose cancer shrinks or disappears after treatment	6 months after treatment