Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

29 novembre 2021 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Réel)

109

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: single -arm
A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Dispositif: 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)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Varian Medical Systems

Les enquêteurs

  • Directeur d'études: Cathy Peng, BSC China

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

24 octobre 2017

Achèvement primaire (Réel)

28 juin 2019

Achèvement de l'étude (Réel)

28 février 2020

Dates d'inscription aux études

Première soumission

6 mars 2017

Première soumission répondant aux critères de contrôle qualité

13 avril 2017

Première publication (Réel)

14 avril 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 décembre 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 novembre 2021

Dernière vérification

1 novembre 2021

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • S2382

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Localized Hepatocellular Carcinoma

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Uganda

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

S'abonner