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Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma

Primary Purpose

Hemangioma Liver

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Propranolol Hydrochloride

About this trial

This is an interventional treatment trial for Hemangioma Liver focused on measuring hepatic hemangioma, propranolol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The second affiliated hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

propranolol

Arm Description

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.

Outcomes

Primary Outcome Measures

Tumor size

Evaluating maximum diameter obtained by contrast-enhanced CT scanning

Secondary Outcome Measures

Objective response rate

Percentage of patients whose cancer shrinks or disappears after treatment

Full Information

NCT ID

NCT03633747

First Posted

August 14, 2018

Last Updated

August 20, 2018

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT03633747

Brief Title

Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma

Official Title

Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

August 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemangioma Liver

Keywords

hepatic hemangioma, propranolol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

propranolol

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Propranolol Hydrochloride

Intervention Description

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

Primary Outcome Measure Information:

Title

Tumor size

Description

Evaluating maximum diameter obtained by contrast-enhanced CT scanning

Time Frame

6 months after treatment

Secondary Outcome Measure Information:

Title

Objective response rate

Description

Percentage of patients whose cancer shrinks or disappears after treatment

Time Frame

6 months after treatment

Other Pre-specified Outcome Measures:

Title

Disease control rate

Description

Percentage of patients whose cancer doesn't progress after treatment

Time Frame

6 months after treatment

Title

Vascular endothelial growth factor

Description

Level of serum Vascular endothelial growth factor

Time Frame

6 months after treatment

Title

Common Toxicity Criteria for Adverse Effects

Description

According to Common Toxicity Criteria for Adverse Effects version 4

Time Frame

6 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tingbo Liang, MD PhD

Phone

8613666676128

liangtingbo@zju.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Qi Zhang, MD

Phone

8613819137113

zhangqi86@gmail.com

Facility Information:

Facility Name

The second affiliated hospital of Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qi Zhang, MD

Phone

8613819137113

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma

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