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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

21 februari 2017 bijgewerkt door: Xiang Hua, Hunan Provincial People's Hospital

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

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

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

190

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • China
    • Guizhou
      • Guiyang, Guizhou, China
        • Guizhou Cancer Hospital
      • Guiyang, Guizhou, China
        • Guizhou Province Tumor Hospital
    • Hunan
      • Changsha, Hunan, China
        • Hunan Cancer Hospital
      • Changsha, Hunan, China
        • Xiangya Hospital Central South University
      • Changsha, Hunan, China, 410001
        • Hunan Provincial People's Hospital
      • Hengyang, Hunan, China
        • The First Affiliated Hospital of University of South China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China
        • Xinjiang Medical University Cancer Hospital
    • Yunnan
      • Kunming, Yunnan, China
        • The Tumor Hospital of Yunnan Province

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

  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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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.
Geneesmiddel: 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.
Actieve vergelijker: 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.
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression free survival
Tijdsspanne: 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.
2-year

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective response rate
Tijdsspanne: 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-year
Overall Survival
Tijdsspanne: 2-year
Overall survival will be measured from the date of randomization up to the date of death of any cause
2-year
Incidence of adverse events
Tijdsspanne: 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.
Up to 2 years through study completion

Andere uitkomstmaten

Uitkomstmaat
Tijdsspanne
Quality of life using EuroQol five dimensions five levels questionnaire
Tijdsspanne: Baseline and week 6, 12, 18, 24 and 30 using EuroQol five dimensions five levels questionnaire
Baseline and week 6, 12, 18, 24 and 30 using EuroQol five dimensions five levels questionnaire

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hunan Provincial People's Hospital

Onderzoekers

  • Hoofdonderzoeker: Hua Xiang, Dr., Hunan Provincial People's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2016

Primaire voltooiing (Verwacht)

1 november 2019

Studie voltooiing (Verwacht)

1 november 2020

Studieregistratiedata

Eerst ingediend

2 november 2016

Eerst ingediend dat voldeed aan de QC-criteria

4 november 2016

Eerst geplaatst (Schatting)

6 november 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 februari 2017

Laatste update ingediend die voldeed aan QC-criteria

21 februari 2017

Laatst geverifieerd

1 februari 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RACE16001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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