A Phase 2 interventional study of TACE and Arsenic trioxide in Primary Hepatocellular Carcinoma, sponsored by Hunan Provincial People's Hospital. Status unknown at 9 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Hunan Provincial People's Hospital · Phase 2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 190 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Hunan Provincial People's Hospital is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Patients in this group are to receive a single dose of TACE treatment on day 1, followed by arsenic trioxide at 10 mg/day for 14 days (day 8-21). TACE treatment is repeated every 9 weeks while arsenic trioxide every 3 weeks for treatment duration of 27 weeks. At least 3 cycles of arsenic trioxide are administrated.
Drug: TACE · Drug: Arsenic trioxide
Patients in this group are to receive a single dose of TACE treatment on day 1. TACE treatment is repeated every 9 weeks for 27 weeks.
Drug: TACE
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.
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
Quality of life using EuroQol five dimensions five levels questionnaire
Time frame: Baseline and week 6, 12, 18, 24 and 30 using EuroQol five dimensions five levels questionnaire
Plan to share: No
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This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Hunan Provincial People's Hospital