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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Hospital of China Medical University
• Collaborators: Fudan University; Sun Yat-sen University; Xijing Hospital; Zhongda Hospital
• Treatments: Arsenic Trioxide; Chlorotrianisene

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.