A Phase 2/3 interventional study of Arsenic trioxide TACE and Arsenic trioxide intravenous infusion in Carcinoma, Hepatocellular, sponsored by Guangdong Provincial People's Hospital. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-06-05.
Sponsored by Guangdong Provincial People's Hospital · Phase 2/3, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 258 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Guangdong Provincial People's Hospital is the lead sponsor of 231 studies on the registry; 101 are open to participants now.
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Adequate results for laboratory tests, including:
Exclusion Criteria:
Disease should be excluded:
Medical history and concomitant diseases:
(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：
Forbidden therapies and/or drugs:
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.
Device: Arsenic trioxide TACE · Drug: lipiodol
1. 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.
Device: Arsenic trioxide TACE · Drug: Arsenic trioxide intravenous infusion · Drug: lipiodol · Drug: NaCl solution
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.
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).
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.
Overall Survival
Overall survival in our study is defined as the time from a patient's enrollment to the time for death.
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.
Quality of Life
Quality of life is assessed according to the FACT-Hep questionnaire.
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
Safety of our treatment plan will be assessed according to the Common Terminology Criteria for Adverse Events（CTCAE） 3.0
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.
Extrahepatic Metastasis Rate
Extrahepatic metastasis rate is defined as the proportion of the extrahepatic metastasis for patients who were absent of extrahepatic metastasis at enrollment.
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.
Recurrence Rate
Recurrence rate is defined as the proportion of the recurrence in the patients.
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.
No study locations are listed for this record.
This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Guangdong Provincial People's Hospital