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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hao Chen, Fudan University
ClinicalTrials.gov Identifier:
NCT01715532
First received: August 17, 2012
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Carcinoma, Hepatocellular
Drug: Huachansu
Other: TACE
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Progression free survival [ 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From date of randomization until the date of death, assessed up to 100 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: transcatheter arterial chemoembolization

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715532

Locations
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Hao Chen, MD, Ph D Fudan University
  More Information

No publications provided

Responsible Party: Hao Chen, Associated Professor, MD, Ph D, Fudan University
ClinicalTrials.gov Identifier: NCT01715532     History of Changes
Other Study ID Numbers: 2012.01
Study First Received: August 17, 2012
Last Updated: October 24, 2012
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by Fudan University:
Huachansu
Na+/K+-ATPase α3
transcatheter arterial chemoembolization
randomized controlled trial

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 30, 2014