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

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01715532

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular	Drug: Huachansu Other: TACE	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2016

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Huachansu + TACE 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.	Drug: Huachansu Other: TACE Other Names: transcatheter arterial chemoembolization
Active Comparator: TACE 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.	Other: TACE Other Names: transcatheter arterial chemoembolization

Arm

Intervention/Treatment

Experimental: Huachansu + TACE

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.

Drug: Huachansu

Other: TACE

Other Names:

transcatheter arterial chemoembolization

Active Comparator: TACE

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.

Other: TACE

Other Names:

transcatheter arterial chemoembolization

Outcome Measures

Primary Outcome Measures

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.]

Secondary Outcome Measures

Overall survival [From date of randomization until the date of death, assessed up to 100 months.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.