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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arsenic trioxide TACE | Active Comparator | 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. |
|
| Arsenic trioxide TACE+IV | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arsenic trioxide TACE | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival in our study is defined as the time from a patient's enrollment to the time for death. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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:
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:
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:
Allergic reactions to arsenic trioxide and any other drugs used in this trail;
Forbidden therapies and/or drugs:
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| Name | Affiliation | Role |
|---|---|---|
| Ligong Lu, Doctor | Guangdong Provincial People's Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D004998 | Ethiodized Oil |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 |
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| Arsenic trioxide intravenous infusion | Drug | 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 | Drug | Lipiodol is used to dissolve arsenic trioxide for TACE,with the dosage decided according to the volume of the target lesion. |
|
| NaCl solution | Drug | 250ml NaCl solution is used to dissolve the arsenic trioxide for intravenous infusion. |
|
Quality of life is assessed according to the FACT-Hep questionnaire. |
| 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 | 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. |
| 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. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |