Know Cancer

or
forgot password

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)
Both
Carcinoma, Hepatocellular

Thank you

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
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;

Type of Study:

Interventional

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:

No

Principal Investigator

Ligong Lu, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangdong General Hospital

Authority:

China: Ethics Committee

Study ID:

GDREC2013109H(R1)

NCT ID:

NCT01861912

Start Date:

June 2013

Completion Date:

December 2016

Related Keywords:

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

Name

Location