Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

29. November 2021 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Tatsächlich)

109

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: single -arm
A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Gerät: 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)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Varian Medical Systems

Ermittler

  • Studienleiter: Cathy Peng, BSC China

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. Oktober 2017

Primärer Abschluss (Tatsächlich)

28. Juni 2019

Studienabschluss (Tatsächlich)

28. Februar 2020

Studienanmeldedaten

Zuerst eingereicht

6. März 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. April 2017

Zuerst gepostet (Tatsächlich)

14. April 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Dezember 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. November 2021

Zuletzt verifiziert

1. November 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • S2382

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Localized Hepatocellular Carcinoma

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in United Kingdom

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren