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Arsenic Trioxide TACE and Intravenous Administration Compared With Arsenic Trioxide TACE Alone in Unresectable Hepatocellular Carcinoma: a Randomized, Parallel, Controlled, Multi-center Clinical Study

Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling by invite only)
Carcinoma, Hepatocellular

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Trial Information

Arsenic Trioxide TACE and Intravenous Administration Compared With Arsenic Trioxide TACE Alone in Unresectable Hepatocellular Carcinoma: a Randomized, Parallel, Controlled, Multi-center Clinical Study

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

- 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

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 /

3. Radiotherapy within 4 weeks;

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression

Outcome Description:

Time to progression in our study is defined as the time from a patient's enrollment to the time for disease progression (according to Recist1.1).

Outcome Time Frame:

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.

Safety Issue:


Principal Investigator

Ligong Lu, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangdong General Hospital


China: Ethics Committee

Study ID:




Start Date:

June 2013

Completion Date:

December 2016

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma, Hepatocellular
  • Arsenic trioxide
  • Carcinoma
  • Carcinoma, Hepatocellular