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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Carcinoma, Hepatocellular

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

Hao Chen, MD, Ph D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Study ID:

2012.01

NCT ID:

NCT01715532

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Carcinoma, Hepatocellular
  • Huachansu
  • Na+/K+-ATPase α3
  • transcatheter arterial chemoembolization
  • randomized controlled trial
  • Carcinoma
  • Carcinoma, Hepatocellular

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