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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 rate

progression 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

Page last updated: August 23, 2015

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