A Prospective Multicenter Randomized Controlled Open-label Trial of Transcatheter Arterial Chemoembolization (TACE) in Combination With Arsenic Trioxide Versus TACE in the Treatment of Middle-advanced Primary Hepatocellular Carcinoma (HCC) Patients
Overview
- Phase
- Phase 2
- Intervention
- TACE
- Conditions
- Primary Hepatocellular Carcinoma
- Sponsor
- Hunan Provincial People's Hospital
- Enrollment
- 190
- Locations
- 9
- Primary Endpoint
- Progression free survival
- Last Updated
- 9 years ago
Overview
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.
Investigators
Xiang Hua
Dr.
Hunan Provincial People's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
TACE plus 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.
Intervention: TACE
TACE plus 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.
Intervention: Arsenic trioxide
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.
Intervention: TACE
Outcomes
Primary Outcomes
Progression free survival
Time Frame: 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 Outcomes
- Incidence of adverse events(Up to 2 years through study completion)
- Overall Survival(2-year)
- Objective response rate(2-year)