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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Huachansu; Other: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT01715532

HCS-2012

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Huachansu + TACE

Experimental group

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.

Treatment:

Drug: Huachansu

Other: TACE

TACE

Active Comparator group

Description:

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.

Treatment:

Other: TACE