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

NCT ID: NCT01715532

Last Updated: 2015-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-06-30

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Huachansu; Na+/K+-ATPase α3; transcatheter arterial chemoembolization; randomized controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Huachansu

Intervention Type: DRUG

TACE

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

TACE

Intervention Type: OTHER

Interventions

Huachansu

Intervention Type: DRUG

TACE

Intervention Type: OTHER

Other Intervention Names

transcatheter arterial chemoembolization

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Hao Chen

Associated Professor, MD, Ph D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hao Chen, MD, Ph D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yehua Shen, MD

Role: CONTACT

Phone: 86-21-64175590

Email: yehuash25@163.com

Facility Contacts

Yehua Shen, MD

Role: primary

References

Gao H, He J, Cheng CS, Zhuang L, Chen H, Meng Z. Unresectable hepatocellular carcinoma: transarterial chemoembolisation plus Huachansu - a single-center randomised controlled trial. BMJ Support Palliat Care. 2023 Jul 3;14(e2):e003870. doi: 10.1136/spcare-2022-003870. Online ahead of print.

Reference Type: DERIVED

PMID: 37400162 (View on PubMed)

Other Identifiers

HCS-2012

Identifier Type: -

Identifier Source: org_study_id