Transcatheter Arterial Chemoembolization (TACE) in Combination With Arsenic Trioxide Versus TACE in the Treatment of Middle-advanced Primary Hepatocellular Carcinoma (HCC) Patients
- Registration Number
- NCT02956772
- Lead Sponsor
- Hunan Provincial People's Hospital
- Brief Summary
A multicentre, randomized, open-label, parallel-group, active controlled study.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 190
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TACE plus Arsenic Trioxide TACE 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. TACE TACE 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. TACE plus Arsenic Trioxide Arsenic trioxide 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.
- Primary Outcome Measures
Name Time Method Progression free survival 2-year 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.
- Secondary Outcome Measures
Name Time Method Incidence of adverse events Up to 2 years through study completion Toxicities will be evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v 4.0.
Overall Survival 2-year Overall survival will be measured from the date of randomization up to the date of death of any cause
Objective response rate 2-year 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.
Trial Locations
- Locations (9)
The First Affiliated Hospital of University of South China
🇨🇳Hengyang, Hunan, China
Guizhou Cancer Hospital
🇨🇳Guiyang, Guizhou, China
Guizhou Province Tumor Hospital
🇨🇳Guiyang, Guizhou, China
Xinjiang Medical University Cancer Hospital
🇨🇳Urumqi, Xinjiang, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Tumor Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China