Clinical trial NCT03633747: Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma
Official title: Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hemangioma Liver
Keywords: hepatic hemangioma
propranolol
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tumor size
timeFrame: 6 months after treatment
Secondary outcomes:
measure: Objective response rate
timeFrame: 6 months after treatment
Other outcomes:
measure: Disease control rate
timeFrame: 6 months after treatment
measure: Vascular endothelial growth factor
timeFrame: 6 months after treatment
measure: Common Toxicity Criteria for Adverse Effects
timeFrame: 6 months after treatment
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
References: