Clinical trial NCT01715532: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
Keywords: Huachansu
Na+/K+-ATPase α3
transcatheter arterial chemoembolization
randomized controlled trial
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression free survival
timeFrame: 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 outcomes:
measure: Overall survival
timeFrame: From date of randomization until the date of death, assessed up to 100 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Hao Chen, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
References: