Transcatheter Arterial Chemoembolization (TACE) in Combination With Arsenic Trioxide Versus TACE in the Treatment of Middle-advanced Primary Hepatocellular Carcinoma (HCC) Patients
NCT ID: NCT02956772
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
190 participants
INTERVENTIONAL
2016-11-30
2020-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Arsenic Trioxide Contained in TACE in the Treatment of HCC
NCT02018757
Adjuvant Transcatheter Arterial Chemoembolization Versus Adjuvant Systemic Chemotherapy for Hepatocellular Carcinoma
NCT02584556
Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma
NCT02038296
Postoperative TACE(Transhepatic Arterial Chemotherapy And Embolization) for Patients With Hepatocellular Carcinoma
NCT02109146
Treatment of Intermediate-stage Hepatocellular Carcinoma
NCT03274427
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject has no portal stem vein tumor thrombus.
3. Subject has primary middle-advanced liver cancer of Barcelona Clinic Liver Cancer stages B/C inappropriate for surgical resection or other locoregional therapy and still presents with tumor lesions in the liver.
4. Subject has evaluable tumor lesion(s) (using Magnetic Resonance Imaging /Computed Tomography) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1: single lesion size ≥5cm or at least one lesion of \>3cm in size when 2-3 lesions exist or there are 4 or more lesions.
5. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤1, Fibrosis index based on 4 factors (FIB-4)≤6 and an expected survival time of 12 weeks or more.
6. Haematology: white blood cell count ≥3.0×10\^9/L; hemoglobin≥10 g/dL; blood platelet count≥80×10\^9/L
7. Blood biochemistry: serum albumin ≥2.8 g/dL, total bilirubin ≤2 mg/dL or ≤34.2 umol/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 times of upper limit of normal (ULN); amylase and lipase ≤ 1.5 times of ULN; serum creatinine ≤2.0 mg/dL or \< 1.5 times of ULN; estimated creatinine clearance ≥60 mL/min.
8. International normalized ratio (INR) is ≤ 2.3 or prothrombin time (PT) is ≤3 seconds than upper limit of normal control.
9. Echocardiogram indicated a left ventricular ejection fraction (LVEF) of \>50%.
10. Subject has a liver function Child-Pugh class A or B.
11. Subject is not pregnant or lactating.
12. Female subjects must be infertile or agree to take effective contraceptives; male subjects and their partners of reproductive potential must also agree to use appropriate contraceptives.
13. Subject had no second tumor in the last 5 years, excluding skin basal cell carcinoma or skin squamous carcinoma or any other carcinoma in situ.
14. Subject had no history of systemic chemotherapy.
15. Subject has no any other concomitant anticancer therapies, such as local radiotherapy, systemic chemotherapy and molecular targeted therapy.
16. Subject and (or) guardian is able to understand this study and willing to provide written, informed consent to participate in this clinical study.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hunan Provincial People's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiang Hua
Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hua Xiang, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hunan Provincial People's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Lin Long, Dr.
Role: CONTACT
Hua Xiang, Dr.
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hua Xiang, Dr.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RACE16001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.