Arsenic Trioxide TACE and Intravenous Administration in Unresectable Hepatocellular Carcinoma

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether compared with arsenic trioxide TACE alone, arsenic trioxide TACE and intravenous administration could further prolong the overall survival.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong General Hospital; Guangdong Provincial People's Hospital
• Treatments: Arsenic Trioxide; Chlorotrianisene; Ethiodized Oil; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Having signed informed consent;

• Histological or clinical diagnosis of hepatocellular carcinoma（HCC）;

• The target lesion should had at least one diameter line available for measurement, with the maximum diameter ≥5cm and ≤10cm；

• Barcelona Clinic Liver Cancer staging B or C;

• Child-Pugh liver function class: score≤7；

• Eastern Cooperative Oncology Group performance 0 or 1;

• At least 12 weeks life expectancy;

• Never received systemic treatment, such as oral molecularly targeted drugs and systemic chemotherapy;

• Be able to abide by the treatment and follow-up plan；

• Adequate results for laboratory tests, including:

1. Neutrophil count≥1.5×109/L, platelet count≥60×109 /L; hemoglobin≥85g/L;

2. Total bilirubin≤51.3 μmol/L, albumin≥28 g/L,and alanine aminotransferase and aspartate aminotransferase≤5 times the upper limit of the normal range;

3. Amylase and lipase≤1.5 times the upper limit of the normal range

4. Serum creatinine≤20 g/L

5. Prothrombin time international normalized ratio ≤1.7; or prothrombin time≤4seconds above control;

6. Left ventricular ejection fraction≥50% according to two-dimensional echocardiography;

• Contraception: during the trail and 12 weeks after the withdrawal, female of childbearing age (WOCBP), WOCBP whose male partners receive study drug or male must use appropriate contraceptive to avoid pregnancy;

Exclusion Criteria:

• Disease should be excluded:

1. CT / MRI showed diffuse lesions;

2. Extrahepatic metastasis (metastasis in lungs not included);

3. Invasion in the main portal vein / vena cava or other major vascular;

4. Previous shunt surgery;

5. PreviousTACE or transarterial embolization for HCC, unless there is a untreated lesion;

6. Hepatic encephalopathy in the past or present;

7. Current ascites requiring treatment;

• Medical history and concomitant diseases:

1. Previous or current cancer other than HCC, unless it is cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1). Cancer having received curative treatment 5 years ago will not be excluded;

2. Disease history in the cardiovascular system as the following:

(a)Uncontrolled hypertension；(b)Congestive heart failure in New York Heart Association grade 3 or 4; (c)Active coronary artery disease within 12 months, unstable angina or newly diagnosed angina/myocardial infarction;(d)Arrhythmia requiring drugs other than β-blockers and digoxin;(e)Valvular heart disease ≥ CTCAE grade 2； c) Corrected QT interval (Fridericia)> 450 ms confirmed by 2 ECGs in a row d) Thrombotic or embolic events within 6 months, e) Gastrointestinal bleeding within 6 months; f) Unstable and / or active stomach ulcer within 6 months, unless gastroscopy showed it to be fully recovered; g) Variceal bleeding within 6 months; h) Unhealed wound or ulcer, fracture within 3 months; i) Major surgery, open biopsy, or severe trauma within 3 weeks; j) History of organ transplant or subjects in the transplant waiting list; k) Uncontrolled abnormal thyroid function; l) HIV infection; m) Active or untreated hepatitis B;

• laboratory tests unsuitable for the enrollment：

1. Hyponatremia, serum sodium <130 mmol / L；

2. Hypokalemia, serum potassium <3.5 mmol / L；

• Allergic reactions to arsenic trioxide and any other drugs used in this trail;

• Forbidden therapies and/or drugs:

1. Condensation treatment (e.g., warfarin or heparin);

2. Chronic antiplatelet therapy (Aspirin ≥ 300 mg / day; clopidogrel ≥ 75 mg / day);

3. Radiotherapy within 4 weeks;