Arsenic Trioxide TACE and Intravenous Administration in Unresectable Hepatocellular Carcinoma
ACTION
1 other identifier
interventional
258
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2013
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2013
CompletedFirst Posted
Study publicly available on registry
May 24, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 5, 2013
June 1, 2013
3 years
May 16, 2013
June 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Progression
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).
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.
Secondary Outcomes (3)
Overall Survival
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.
Quality of Life
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
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.
Other Outcomes (2)
Extrahepatic Metastasis Rate
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.
Recurrence Rate
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.
Study Arms (2)
Arsenic trioxide TACE
ACTIVE COMPARATORArsenic trioxide TACE: arsenic trioxide powder 20mg dissolved in lipiodol(the dosage of lipiodol is decided according to the volume of the target lesion)is used for transcatheter arterial chemoembolization(TACE). TACE will be repeated after 4\~6 weeks if it is necessary according to the assessment from imaging modalities.
Arsenic trioxide TACE+IV
EXPERIMENTAL1. Arsenic trioxide TACE: arsenic trioxide powder 20mg dissolved in lipiodol(the dosage of lipiodol is decided according to the volume of the target lesion)is used for transcatheter arterial chemoembolization(TACE). TACE will be repeated after 4\~6 weeks if it is necessary according to the assessment from imaging modalities. 2. Arsenic trioxide intravenous infusion: arsenic trioxide powder 0.15mg/Kg/d(maxim 10mg/d) dissolved in 250ml 0.9% sodium chloride solution is used for intravenous infusion.Every course will last for 3 weeks and the next course will be continued after 1 week suspension.Intravenous infusion will be suspended 3 days before and 7\~14 days after TACE.
Interventions
Arsenic trioxide powder 20mg dissolved in lipiodol(the dosage of lipiodol is decided according to the volume of the target lesion)is used for transcatheter arterial chemoembolization(TACE). TACE will be repeated after 4\~6 weeks if it is necessary according to the assessment from imaging modalities
Arsenic trioxide intravenous infusion: arsenic trioxide powder 0.15mg/Kg/d(maxim 10mg/d) dissolved in 250ml 0.9%NaCl solution is used for intravenous infusion.Every course will last for 3 weeks and the next course will be continued after 1 week suspension.Intravenous infusion will be suspended 3 days before and 7\~14 days after TACE.
Lipiodol is used to dissolve arsenic trioxide for TACE,with the dosage decided according to the volume of the target lesion.
250ml NaCl solution is used to dissolve the arsenic trioxide for intravenous infusion.
Eligibility Criteria
You may qualify if:
- 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:
- Neutrophil count≥1.5×109/L, platelet count≥60×109 /L; hemoglobin≥85g/L;
- 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;
- Amylase and lipase≤1.5 times the upper limit of the normal range
- Serum creatinine≤20 g/L
- Prothrombin time international normalized ratio ≤1.7; or prothrombin time≤4seconds above control;
- +2 more criteria
You may not qualify if:
- Disease should be excluded:
- CT / MRI showed diffuse lesions;
- Extrahepatic metastasis (metastasis in lungs not included);
- Invasion in the main portal vein / vena cava or other major vascular;
- Previous shunt surgery;
- PreviousTACE or transarterial embolization for HCC, unless there is a untreated lesion;
- Hepatic encephalopathy in the past or present;
- Current ascites requiring treatment;
- Medical history and concomitant diseases:
- 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;
- 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：
- Hyponatremia, serum sodium \<130 mmol / L；
- Hypokalemia, serum potassium \<3.5 mmol / L；
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ligong Lu, Doctor
Guangdong Provincial People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 16, 2013
First Posted
May 24, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
June 5, 2013
Record last verified: 2013-06