Phase II Study of Huachansu for Treatment of Advanced Hepatocellular Carcinoma and the Correlation With Na+/K+-ATPase
- 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
- 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
- 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
- History of other malignant tumor in 5 years.
- Pregnant or lactating women.
- Mentally disordered.
- Participation of other clinical trials within a month.