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Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma

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ClinicalTrials.gov Identifier: NCT03633747
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Hemangioma Liver Drug: Propranolol Hydrochloride Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks

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




Primary Outcome Measures :
  1. Tumor size [ Time Frame: 6 months after treatment ]
    Evaluating maximum diameter obtained by contrast-enhanced CT scanning


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 6 months after treatment ]
    Percentage of patients whose cancer shrinks or disappears after treatment


Other Outcome Measures:
  1. Disease control rate [ Time Frame: 6 months after treatment ]
    Percentage of patients whose cancer doesn't progress after treatment

  2. Vascular endothelial growth factor [ Time Frame: 6 months after treatment ]
    Level of serum Vascular endothelial growth factor

  3. Common Toxicity Criteria for Adverse Effects [ Time Frame: 6 months after treatment ]
    According to Common Toxicity Criteria for Adverse Effects version 4



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633747


Contacts
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Contact: Tingbo Liang, MD PhD 8613666676128 liangtingbo@zju.edu.cn
Contact: Qi Zhang, MD 8613819137113 zhangqi86@gmail.com

Locations
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China, Zhejiang
The second affiliated hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Qi Zhang, MD    8613819137113      
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03633747     History of Changes
Other Study ID Numbers: SAHZJU-Y2018-059
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
hepatic hemangioma
propranolol

Additional relevant MeSH terms:
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Propranolol
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents