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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. februar 2017 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Forventet)

190

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Lin Long, Dr.
  • Telefonnummer: 86-13507476175

Studer Kontakt Backup

  • Navn: Hua Xiang, Dr.
  • Telefonnummer: 85-13667367061

Studiesteder

  • Kina
    • Guizhou
      • Guiyang, Guizhou, Kina
        • Guizhou Cancer Hospital
        • Ta kontakt med:
      • Guiyang, Guizhou, Kina
        • Guizhou Province Tumor Hospital
        • Ta kontakt med:
    • Hunan
      • Changsha, Hunan, Kina
      • Changsha, Hunan, Kina
      • Changsha, Hunan, Kina, 410001
        • Hunan Provincial People's Hospital
        • Ta kontakt med:
          • Hua Xiang, Dr.
          • Telefonnummer: +86-13667367061
        • Ta kontakt med:
      • Hengyang, Hunan, Kina
        • The First Affiliated Hospital of University of South China
        • Ta kontakt med:
    • Jiangsu
      • Nanjing, Jiangsu, Kina
    • Xinjiang
      • Urumqi, Xinjiang, Kina
    • Yunnan
      • Kunming, Yunnan, Kina

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

  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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Legemiddel: 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.
Aktiv komparator: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression free survival
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective response rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tidsramme
Quality of life using EuroQol five dimensions five levels questionnaire
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hunan Provincial People's Hospital

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2016

Primær fullføring (Forventet)

1. november 2019

Studiet fullført (Forventet)

1. november 2020

Datoer for studieregistrering

Først innsendt

2. november 2016

Først innsendt som oppfylte QC-kriteriene

4. november 2016

Først lagt ut (Anslag)

6. november 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. februar 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RACE16001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Medisinsk tilstand

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Forhold

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