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Role of Huachansu in Treating Hepatocellular Carcinoma and the Correlation With Na+/K+-ATPase

Primary Purpose

Carcinoma, Hepatocellular

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Huachansu

TACE

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Huachansu, Na+/K+-ATPase α3, transcatheter arterial chemoembolization, randomized controlled trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subjects 18-75 years of age.
Diagnosis of hepatocellular carcinoma. Biopsy is the preferred method of diagnosis (option 1). As far as clinically possible, the results of a biopsy should be obtained to confirm the diagnosis prior to the initiation of investigational product administration.. Non-biopsy criteria are allowed in cases where a biopsy result is unavailable and a biopsy procedure is not clinically indicated (option 2). (Option 1: Biopsy-proven HCC (histology or cytology); Option 2 - patient must fulfill the following criteria: i. Radiological evidence of HCC showing lesion arterial hypervascularity and venous phase washout by either dynamic (triple-phase), contrast-enhanced computed tomography of the abdomen OR dynamic (triple-phase) contrast (gadolinium)-enhanced MRI, AND ii. Serology positive for hepatitis B or C, AND iii. Alpha fetoprotein > 400 μg/L at the time of diagnosis.)
No metastasis outside liver.
Unable or unwilling to receive radical surgery.
No prior transcatheter arterial chemoembolization.
No prior treatment of bufalins including Huachansu.
At least one measurable untreated lesion. All subjects must have at least one measurable lesion unidimensionally by CT or MRI scan, according to modified RECIST for HCC, that has not been previously treated with surgery, irradiation, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
Cirrhotic status of Child-Pugh Class A or B.
Adequate hematologic function with absolute neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 50 x 109/L, and hemoglobin ≥ 85 g/L.
Signed Written Informed Consent.
Subjects who have a life expectancy of at least 3 months.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study that the risk of pregnancy is minimized.

Exclusion Criteria:

Previously treated target lesion with irradiation, TACE, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
Cirrhotic status of Child-Pugh Class C.
Severe diseases of heart, liver, kidney, etc that may cause inadequate organ functions
History of other malignant tumor in 5 years.
Pregnant or lactating women.
Mentally disordered.
Participation of other clinical trials within a month.

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Huachansu + TACE

TACE

Arm Description

Patients in this arm will receive Huachansu tablets each 3 and 3 times a day orally, as well as transcatheter arterial chemoembolization every 4 weeks, until progression of disease or adverse effects leading to termination of treatment. Each 4-week period is one cycle of treatment.

Patients in this arm will receive transcatheter arterial chemoembolization every 4 weeks, until progression of disease or adverse effects leading to termination of treatment. Each 4-week period is one cycle of treatment.

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival

Full Information

NCT ID

NCT01715532

First Posted

August 17, 2012

Last Updated

December 16, 2015

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01715532

Brief Title

Role of Huachansu in Treating Hepatocellular Carcinoma and the Correlation With Na+/K+-ATPase

Official Title

Phase II Study of Huachansu for Treatment of Advanced Hepatocellular Carcinoma and the Correlation With Na+/K+-ATPase

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary Outcome Measures: - To compare the progression free survival(PFS) in patients with unresectable hepatocellular carcinoma(HCC) treated with transcatheter arterial chemoembolization(TACE) with or without Huachansu, and the correlation between PFS and expression of peripheral Na+/K+-ATPase α3 family. Secondary Outcome Measures: - To compare the overall survival(OS), objective response rate(ORR), and side effects of treating HCC with TACE plus Huachansu or TACE alone. Exploratory Outcome Measures: - To evaluate the correlation between prognosis and expression of peripheral Na+/K+-ATPase α3 family.

6. Conditions and Keywords

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

Carcinoma, Hepatocellular

Keywords

Huachansu, Na+/K+-ATPase α3, transcatheter arterial chemoembolization, randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Huachansu + TACE

Arm Type

Experimental

Arm Description

Arm Title

TACE

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Huachansu

Intervention Type

Other

Intervention Name(s)

TACE

Other Intervention Name(s)

transcatheter arterial chemoembolization

Primary Outcome Measure Information:

Title

Progression free survival

Time Frame

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

From date of randomization until the date of death, assessed up to 100 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects 18-75 years of age. Diagnosis of hepatocellular carcinoma. Biopsy is the preferred method of diagnosis (option 1). As far as clinically possible, the results of a biopsy should be obtained to confirm the diagnosis prior to the initiation of investigational product administration.. Non-biopsy criteria are allowed in cases where a biopsy result is unavailable and a biopsy procedure is not clinically indicated (option 2). (Option 1: Biopsy-proven HCC (histology or cytology); Option 2 - patient must fulfill the following criteria: i. Radiological evidence of HCC showing lesion arterial hypervascularity and venous phase washout by either dynamic (triple-phase), contrast-enhanced computed tomography of the abdomen OR dynamic (triple-phase) contrast (gadolinium)-enhanced MRI, AND ii. Serology positive for hepatitis B or C, AND iii. Alpha fetoprotein > 400 μg/L at the time of diagnosis.) No metastasis outside liver. Unable or unwilling to receive radical surgery. No prior transcatheter arterial chemoembolization. No prior treatment of bufalins including Huachansu. At least one measurable untreated lesion. All subjects must have at least one measurable lesion unidimensionally by CT or MRI scan, according to modified RECIST for HCC, that has not been previously treated with surgery, irradiation, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation. Cirrhotic status of Child-Pugh Class A or B. Adequate hematologic function with absolute neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 50 x 109/L, and hemoglobin ≥ 85 g/L. Signed Written Informed Consent. Subjects who have a life expectancy of at least 3 months. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study that the risk of pregnancy is minimized. Exclusion Criteria: Previously treated target lesion with irradiation, TACE, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation. Cirrhotic status of Child-Pugh Class C. Severe diseases of heart, liver, kidney, etc that may cause inadequate organ functions History of other malignant tumor in 5 years. Pregnant or lactating women. Mentally disordered. Participation of other clinical trials within a month.

Central Contact Person:

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

Yehua Shen, MD

Phone

86-21-64175590

Ext

83625

yehuash25@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hao Chen, MD, Ph D

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yehua Shen, MD

Phone

86-21-64175590

Ext

83625

yehuash25@163.com

First Name & Middle Initial & Last Name & Degree

Hao Chen, MD

12. IPD Sharing Statement

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Role of Huachansu in Treating Hepatocellular Carcinoma and the Correlation With Na+/K+-ATPase

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