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STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma

29 listopada 2021 zaktualizowane przez: Varian Medical Systems

A Single-arm Trial of Transcatheter Arterial Chemoembolization With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma

A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

It is a prospective, single-arm, multicenter study. The primary effectiveness endpoint for this clinical trial is 6-month overall objective tumor response (ORR).

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

109

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Chiny
    • Beijing
      • Beijing, Beijing, Chiny
        • Beijing Cancer Hospital
      • Beijing, Beijing, Chiny
        • Cancer Hospital Chinese Academy of Medical Sciences
    • Guangdong
      • Guangzhou, Guangdong, Chiny
        • Guangdong Nanfang Hospital
    • Henan
      • Zhengzhou, Henan, Chiny
        • Henan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, Chiny
        • Zhongda Hospital Affiliated Southeast University
    • Liaoning
      • Shenyang, Liaoning, Chiny
        • Shengjing Hospital Affiliated China Medical University
    • Shanghai
      • Shanghai, Shanghai, Chiny
        • Shanghai Zhongshan Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Chiny
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, Chiny
        • The First Affiliated Hospital, Zhejiang University
      • Hangzhou, Zhejiang, Chiny
        • Second Aff. Hosp. of Zhejiang University College of Medicine

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  1. Subject is able to provide informed consent and must sign the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form.
  2. Male or female of age ≥18 and ≤75 years.
  3. Confirmed diagnosis of HCC according to the diagnostic criteria included in the management guideline issued by China's Ministry of Health in 2017.
  4. HCC is diagnosed for the first time or recurrence of tumor after surgical or ablation treatment.
  5. Single tumor less than 7cm in diameter or multiple tumors with maximum 3 lesions with >1cm in diameter, individual diameter <7cm and less than 10cm in total diameter.
  6. no previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) for HCC
  7. Preserved liver function (Child-Pugh A or B7).
  8. ECOG Performance Status 0 or 1.

Exclusion Criteria:

  1. Presence of vascular invasion or extra-hepatic spread of disease, or diffuse HCC, defined as >50% liver involvement , or arteriovenuous fistula
  2. Macrovascular invasion of main or primary branches of portal vein at entry into the study
  3. Any contraindication for TACE treatment
  4. Any contraindication for Epirubicin administration
  5. Advanced liver disease (bilirubin levels >2 mg/dl, AST or ALT >5 times upper limit of normal)
  6. Renal failure or insufficient renal function (Creatinine levels >2 mg/dl)
  7. Subject unable to receive MRI examination
  8. Pregnant or breast feeding woman, or plan to become pregnant during treatment or within 12 months of treatment
  9. couldn't commit reliable birth control measures during treatment or within 12 months of treatment
  10. Subject is participating other investigational drug or device clinical trial within 30 days of signing the informed consent
  11. Subject is not suitable to participate in the study as judged by investigator

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: single -arm
A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Urządzenie: Tandem Microsphere loaded with Epirubicin
The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
Ramy czasowe: At 6 months

The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR.

  1. Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
  2. Per Response Evaluation Criteria In Solid Tumors Criteria (EASL) for target lesions: Complete Response (CR), Disappearance of all known disease and no new lesions determined by two observations not less than 4 weeks apart; Partial Response (PR), At least 50% reduction in total tumor load of all measurable lesions determined by two observations not less than 4 weeks apart.
At 6 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months
Ramy czasowe: At 12 months

Kaplan-Meier analyses the percent of participants for TTP which is defined as the length of time from the treatment initiation to either the date of the first disease progression occurred, as assessed by the investigators, or the date of the subject died due to any cause, whichever comes earlier. EASL and mRECIST response assessment of target lesion for HCC. TTP (also referred as "time to treatment failure") will be measured by a few data items list below:

  • The date of the disease progression in the Overall Response form

  • The date of lost-to-follow due to:

    • Adverse events
    • Progressive disease/insufficient therapeutic response
    • Death
    • Failure to return
    • Refusing treatment/being unwilling to cooperate/withdrawing consent
  • The very last date by scanning all available dates in the database
  • The desired cut-off days
At 12 months
Number of Participants With Objective Tumor Response at 30-day
Ramy czasowe: At 1month

The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR.

  1. Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
  2. Per Response Evaluation Criteria In Solid Tumors Criteria (EASL) for target lesions: Complete Response (CR), Disappearance of all known disease and no new lesions determined by two observations not less than 4 weeks apart; Partial Response (PR), At least 50% reduction in total tumor load of all measurable lesions determined by two observations not less than 4 weeks apart.
At 1month
Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months
Ramy czasowe: from first TACE to 12 months

Kaplan-Meier analyses the percent of participants for PPF which is defined as the length of time from the treatment initiation, that treated subjects are still progression-free. EASL and mRECIST response assessment of target lesion for HCC.

The data items to be captured will include:

  • The date of the disease progression in the Overall Response form
  • The very last date by scanning all available dates in the database
  • The desired cut-off days The proportion of any time point will be determined by the Kaplan-Meier estimates.
from first TACE to 12 months
Kaplan-Meier Analyses the Percent of Participants for Overall Survival
Ramy czasowe: from first TACE to 12 months

Kaplan-Meier analyses the percent of participants for Overall survival which is defined as the length of time from the treatment initiation, that treated subjects are still alive. The Kaplan-Meier analysis is aimed to capture the all-cause death for each subject. Subjects who are lost-to-follow will be considered being censored.

There are three critical data items to be captured:

  • Death date
  • The very last date in the database (e.g. follow-up visit date and/or site reported AE date)
  • The desired cut-off days (e.g. 6-month OS at 182 days, 12-month OS at 365 days) In addition to the Kaplan-Meier survival curve, the median survival time (mOS) will also be used to represent the study cohort.
from first TACE to 12 months
Number of Adverse Events Relate to Study Device in 12 Months Post Procedure
Ramy czasowe: in 12 months
Number and documents of adverse events relate to study device in 12 months post procedure
in 12 months
Number of Participants With Objective Tumor Response at 3 Months
Ramy czasowe: At 3 months

The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR.

  1. Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
  2. Per Response Evaluation Criteria In Solid Tumors Criteria (EASL) for target lesions: Complete Response (CR), Disappearance of all known disease and no new lesions determined by two observations not less than 4 weeks apart; Partial Response (PR), At least 50% reduction in total tumor load of all measurable lesions determined by two observations not less than 4 weeks apart.
At 3 months
Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic Spread
Ramy czasowe: At 12 month

Kaplan-Meier analyses the percent of participants for Time to Extrahepatic Spread which the length of time from the treatment initiation to the development of extrahepatic spread of the disease via imaging assessment.

The data items to be considered will include:

  • The date of the extrahepatic spread in the Overall Response form
  • The very last date by scanning all available dates in the database
  • The desired cut-off days
At 12 month

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Varian Medical Systems

Śledczy

  • Dyrektor Studium: Cathy Peng, BSC China

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

24 października 2017

Zakończenie podstawowe (Rzeczywisty)

28 czerwca 2019

Ukończenie studiów (Rzeczywisty)

28 lutego 2020

Daty rejestracji na studia

Pierwszy przesłany

6 marca 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 kwietnia 2017

Pierwszy wysłany (Rzeczywisty)

14 kwietnia 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 grudnia 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 listopada 2021

Ostatnia weryfikacja

1 listopada 2021

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • S2382

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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