Safety and Efficacy of Arsenic Trioxide Contained in TACE in the Treatment of HCC
Information source: First Hospital of China Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carcinoma, Hepatocellular
Intervention: TACE containing As2O3 (Drug); TACE containing placebo (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: First Hospital of China Medical University Official(s) and/or principal investigator(s): Haibo Shao, MD,PhD, Principal Investigator, Affiliation: First Hospital of China Medical University
Overall contact: Haibo Shao, MD,PHD, Phone: 862483282730, Email: haiboshao@aliyun.com
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.
Clinical Details
Official title: Clinical Application Study of Transarterial Chemoembolization Containing Arsenic Trioxide in the Treatment of Hepatocellular Carcinoma
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: time to progression
Secondary outcome: objective response rateprogression free survival overall survival Proportion of Participants with Adverse Events
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
β-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.
Locations and Contacts
Haibo Shao, MD,PHD, Phone: 862483282730, Email: haiboshao@aliyun.com
Zhongshan Hospital Fudan University, Shanghai, China; Not yet recruiting Jianhua Wang, MD,PHD, Principal Investigator
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; Not yet recruiting Peihong Wu, MD,PHD, Principal Investigator
Zhongda Hospital Southeast University, Nanjing, Jiangsu, China; Not yet recruiting Gaojun Teng, MD,PhD Gaojun Teng, MD,PhD, Principal Investigator
The First Hospital of China Medical University, Shenyang, Liaoning 110001, China; Not yet recruiting Haibo Shao, MD,PHD, Principal Investigator
Xijing Hospital,Fourth Military Medical University, Xi'an, Shaanxi, China; Not yet recruiting Guohong Han, MD,PhD, Principal Investigator
Additional Information
Chinese Clinical Trial Registry National Health and Family Planning Commission of the People's Republic of China
Starting date: January 2014
Last updated: May 25, 2014
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