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

NCT01715532 | Unknown Phase 2 DMC

• 1 other identifier: HCS-2012
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  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 (1)

• Overall survival

  From date of randomization until the date of death, assessed up to 100 months.

Study Arms (2)

Huachansu + TACE

EXPERIMENTAL

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

TACE

ACTIVE COMPARATOR

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

Interventions

Huachansu DRUG

Huachansu + TACE

TACE OTHER

Also known as: transcatheter arterial chemoembolization

Huachansu + TACE; TACE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37400162 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

huachansu

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Hao Chen, MD, Ph D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yehua Shen, MD

CONTACT

86-21-64175590; yehuash25@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor, MD, Ph D

Study Record Dates

• First Submitted: August 17, 2012
• First Posted: October 29, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

CN (1)