Safety and Efficacy of Arsenic Trioxide Contained in TACE in the Treatment of HCC

Carcinoma, Hepatocellular Clinical Trial

— SEATH  

Official title:

Clinical Application Study of Transarterial Chemoembolization Containing Arsenic Trioxide in the Treatment of Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02018757
• Other study ID #: 2012AA022701
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 9, 2013
• Last updated: May 25, 2014
• Start date: January 2014

Study information

• Verified date: May 2014
• Source: First Hospital of China Medical University
• Contact: Haibo Shao, MD,PHD
• Phone: 862483282730
• Email: haiboshao[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether transarterial chemoembolization containing arsenic trioxide is safe and effective in the treatment of intermediate-stage hepatocellular carcinoma.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• accordance with primary hepatocellular carcinoma diagnosis standard:cytohistology standard or non-invasive standard.1)+2)a or 1)+2)b+3)of the following are the non-invasive diagnosis criteria:(1)patients with HBV or HCV related liver cirrhosis.(2)radiological lesion(s) in liver with arterial hypervascularity and venous or delayed phase washout: a.one kind of imaging technology diagnosis for those with lesions>2cm;b.two kinds of imaging technology obtains the consistent conclusion for lesions with diameter of 1-2 cm.(3)serum AFP level =400 ug/L lasting for more than 1 month or =200 ug/L lasting for more than 2 months, other diseases that may cause the AFP level increase can be excluded,such as pregnancy, genital or embryonic tumors and active hepatitis.

• age of 18 to 75 year,male or female

• life expectancy of 12 weeks

• Barcelona Clinic Liver Cancer (BCLC)stage B

• laboratory tests:(1)leukocyte>3*19^9/L;(2)hemoglobin=8.5g/dl;(3)platelet count =50*10^9/L,(4)ALT and AST were less than three times the normal limit;(5)albumin = 3.0 g/dl;(6)total bilirubin acuities 3 mg/dl;(7)prothrombin time international standardization ratio (PT - INR) < = 2.3 or prothrombin time (PT)more than normal compared 3 seconds;(8)serum creatinine is less than 1.5 times the normal of the upper limit

• patients with signed informed consent

Exclusion Criteria:

• concomitant malignancies distinct from HCC currently or previously

• allergic to subject agent(such as arsenic) or other agent related to the trial

• BCLC stage 0,A,C or D

• HCC accounting for the 70% of the liver size or more

• liver function Child-Pugh score of C

• ECOG score of 1 or higher

• severe heart diseases,such as congestive heart failure with cardiac function of New York Heart Association(NYHA)functional class II or severe, active coronary disease(except for who with myocardial infarction for more than 6 months) and cardiac arrhythmia needing medical management(except for that controllable by ß-blockers?calcium channel blockers and digoxin )

• uncontrollable hypertension(diastolic blood pressure cannot be controlled below 90 mmHg even after antihypertension treatment by antihypertensive drugs).

• active severe infection(grade 2 or higher according to NCI-CTCAE version 4.0)

• active tuberculosis or pulmonary tuberculosis cannot be excluded

• CNS malignancies, including intracranial metastases

• gastrointestinal bleeding with clinical findings in the previous 30 days

• chronic renal failure

• pregnancy or breastfeeding

• any other unstable conditions or circumstances possibly to jeopardise the safety or compliance of the subjects.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• TACE containing As2O3
transarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol
• TACE containing placebo
transarterial chemoembolization containing a mixture of 20mg of placebo, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Zhongshan Hospital Fudan University	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Xijing Hospital,Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (5)

Lead Sponsor	Collaborator
First Hospital of China Medical University	Fudan University, Sun Yat-sen University, Xijing Hospital, Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to progression		From date of randomization until the date of first documented progression, up to 24 months	No
Secondary	objective response rate	patients proportion of CR and PR according to mRECIST	every 3 months from randomization until the date of first documented progression, up to 24 months	No
Secondary	progression free survival	survival from randomization to the date of first documented progression according to the mRECIST criterion	From date of randomization until the date of first documented progression, up to 24 months	No
Secondary	overall survival		From date of randomization until the date of death from any cause, up to 60 months	No
Secondary	Proportion of Participants with Adverse Events		every 3 months from randomization until the date of first documented progression, up to 24 months	Yes

External Links

•   National Health and Family Planning Commission of the People's Republic of China