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Transcatheter Arterial Chemoembolization (TACE) in Combination With Arsenic Trioxide Versus TACE in the Treatment of Middle-advanced Primary Hepatocellular Carcinoma (HCC) Patients

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ClinicalTrials.gov Identifier: NCT02956772
Recruitment Status : Not yet recruiting
First Posted : November 7, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Xiang Hua, Hunan Provincial People's Hospital

Brief Summary:
A multicentre, randomized, open-label, parallel-group, active controlled study.

Condition or disease Intervention/treatment Phase
Primary Hepatocellular Carcinoma Drug: TACE Drug: Arsenic trioxide Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arsenic

Arm Intervention/treatment
Experimental: 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.
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.

Drug: 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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Objective response rate [ Time Frame: 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.

  2. Overall Survival [ Time Frame: 2-year ]
    Overall survival will be measured from the date of randomization up to the date of death of any cause

  3. Incidence of adverse events [ Time Frame: 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.


Other Outcome Measures:
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Subject is 18-80 years old.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956772


Contacts
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Contact: Lin Long, Dr. 86-13507476175
Contact: Hua Xiang, Dr. 85-13667367061

Locations
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China, Guizhou
Guizhou Cancer Hospital Not yet recruiting
Guiyang, Guizhou, China
Contact: Shi Zhou, Dr.       258600801@qq.com   
Guizhou Province Tumor Hospital Not yet recruiting
Guiyang, Guizhou, China
Contact: Junxiang Li, Dr.       258600801@qq.com   
China, Hunan
Hunan Provincial People's Hospital Not yet recruiting
Changsha, Hunan, China, 410001
Contact: Hua Xiang, Dr.    +86-13667367061      
Contact: Lin Long, Dr.    +86-13507476175    doclongll@163.com   
Hunan Cancer Hospital Not yet recruiting
Changsha, Hunan, China
Contact: Guowen LI, Dr.       liguowen@hnszlyy.com   
Xiangya Hospital Central South University Not yet recruiting
Changsha, Hunan, China
Contact: Chunhui Zhou, Dr.       zhouchunhui2016@163.com   
The First Affiliated Hospital of University of South China Not yet recruiting
Hengyang, Hunan, China
Contact: Youhua Wu, Dr.       330270372@qq.com   
China, Jiangsu
Jiangsu Province Hospital Not yet recruiting
Nanjing, Jiangsu, China
Contact: Zhen-Qiang Yang, Dr.       ntdoctoryang@hotmail.com   
China, Xinjiang
Xinjiang Medical University Cancer Hospital Not yet recruiting
Urumqi, Xinjiang, China
Contact: Shufa Yang, Dr.       yangshufa2013@sina.com   
China, Yunnan
The Tumor Hospital of Yunnan Province Not yet recruiting
Kunming, Yunnan, China
Contact: Ming Huang, Dr.       huangming4328@sina.com   
Sponsors and Collaborators
Hunan Provincial People's Hospital
Investigators
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Principal Investigator: Hua Xiang, Dr. Hunan Provincial People's Hospital

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Responsible Party: Xiang Hua, Dr., Hunan Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT02956772     History of Changes
Other Study ID Numbers: RACE16001
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Arsenic Trioxide
Antineoplastic Agents