Hemangioma Liver
Conditions
Keywords
hepatic hemangioma, propranolol
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.
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.
Interventions
DRUGPropranolol Hydrochloride
Oral propranolol hydrochloride tablets are administration for 6 months at dose of 1.5 mg/kg or the maximum dose tolerable.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor size | 6 months after treatment | Evaluating maximum diameter obtained by contrast-enhanced CT scanning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 6 months after treatment | Percentage of patients whose cancer shrinks or disappears after treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | 6 months after treatment | Percentage of patients whose cancer doesn't progress after treatment |
| Vascular endothelial growth factor | 6 months after treatment | Level of serum Vascular endothelial growth factor |
| Common Toxicity Criteria for Adverse Effects | 6 months after treatment | According to Common Toxicity Criteria for Adverse Effects version 4 |
Countries
China
Outcome results
None listed