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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01715532
• Other study ID #: HCS-2012
• Status: Recruiting
• Phase: Phase 2
• First received: August 17, 2012
• Last updated: December 16, 2015
• Start date: July 2012
• Est. completion date: June 2016

Study information

• Verified date: December 2015
• Source: Fudan University
• Contact: Yehua Shen, MD
• Phone: 86-21-64175590
• Email: yehuash25[@]163.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Huachansu

Other:
• TACE

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		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.	No
Secondary	Overall survival		From date of randomization until the date of death, assessed up to 100 months.	No