Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma (NCT03633747) | Clinical Trial Compass
TerminatedPhase 1/2
Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma
Stopped: Limited efficacy
China8 participantsStarted 2018-07-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 acut…
What they're measuring
1
Tumor size
Timeframe: 6 months after treatment
Trial details
NCT IDNCT03633747
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University