Role of Huachansu in Treating Hepatocellular Carcinoma and the Correlation With Na+/K+-ATPase
This study is ongoing, but not recruiting participants.
Sponsor:
Fudan University
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
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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 |
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 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 Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 22, 2013