A multicentre, randomized, open-label, parallel-group, active controlled study.
Primary hepatocellular carcinoma (HCC) is one of the most common types of cancer and accounts for significant morbidity and mortality worldwide. Notably, more than half of the new HCC cases and deaths develop in China. Transarterial chemoembolization (TACE) has been proposed as the first-line therapeutic strategy for the treatment of patients with unresectable HCC. However, TACE has several limitations itself which might be potentially associated with tumor metastasis and relapse. Recent studies have demonstrated that arsenic trioxide (As2O3) can act as the first-line therapeutic option in the treatment of acute promyelocytic leukemia. Thereafter, several small studies in China showed promising clinical benefits when As2O3 is administrated among the HCC patients. With these preliminary results, the investigators are planning to carry out a multicenter randomized controlled trial through which to explore the potential efficacy and safety of adjuvant As2O3 treatment for HCC patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
After the puncture of femoral artery via Seldinger method, a catheter was inserted and digital celiac axis or hepatic arteriography performed. Then a microcatheter was used to infuse chemotherapeutic agent (30 to 60 mg of pirarubicin) mixed with 5 to 20 mL of Lipiodol Ultra-Fluid. Embosphere microspheres (size of 100 to 300 um) were inserted for embolization.
Arsenic trioxide 10 mg is put into 500 ml saline solution and then administrated by continuous intravenous drip for 5 hours during a treatment day.
Guizhou Cancer Hospital
Guiyang, Guizhou, China
Guizhou Province Tumor Hospital
Guiyang, Guizhou, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Progression free survival
Progression free survival (PFS) is defined as the time interval from the day of the random assignment to the first evidence of progression or death.
Time frame: 2-year
Objective response rate
Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to RECIST and will be assessed by the investigators. The tumor objective response rate (ORR) is calculated per treatment arm as the proportion of randomized patients having a confirmed best response of CR or PR.
Time frame: 2-year
Overall Survival
Overall survival will be measured from the date of randomization up to the date of death of any cause
Time frame: 2-year
Incidence of adverse events
Toxicities will be evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v 4.0.
Time frame: Up to 2 years through study completion
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Xiangya Hospital Central South University
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, China
The Tumor Hospital of Yunnan Province
Kunming, Yunnan, China