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.

Yttrium-90 Carbon Microsphere Radioembolization in Previously Treated Hepatocellular Carcinoma

15 juin 2026 mis à jour par: Second Affiliated Hospital of Guangzhou Medical University

A Prospective, Open-Label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of NRT6003 Injection (Yttrium-90 Carbon Microspheres) Radioembolization in Previously Treated Patients With Hepatocellular Carcinoma

This is a prospective, open-label, single-arm, investigator-initiated study designed to evaluate the safety and efficacy of NRT6003 Injection, a yttrium-90 carbon microsphere product, administered by selective internal radiation therapy in previously treated patients with hepatocellular carcinoma.

Eligible participants will undergo protocol-specified screening assessments, hepatic vascular evaluation, 99mTc-MAA hepatic arterial perfusion imaging, and dosimetry assessment before treatment. Participants who meet the eligibility criteria and are considered suitable for selective internal radiation therapy will receive a single transarterial administration of NRT6003 Injection. Safety follow-up will be conducted for 12 months after treatment, and tumor response will be assessed using mRECIST and RECIST v1.1.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

20

Phase

  • Phase 2

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.

Coordonnées de l'étude

  • Nom: Jingjun Huang, MD
  • Numéro de téléphone: +86-20-34156205
  • E-mail: junooi@foxmail.com

Lieux d'étude

  • Chine
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510260
        • The Second Affiliated Hospital, Guangzhou Medical University
        • Contact:
        • Chercheur principal:
          • Kangshun Zhu, MD
        • Sous-enquêteur:
          • Jingjun Huang, MD

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

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

1. Age 18 years or older, male or female, with body weight greater than 30 kg. 2. Clinically, radiologically, and/or pathologically diagnosed hepatocellular carcinoma. 3. Previously treated with TACE, and/or HAIC, and considered by the investigator to be able to tolerate yttrium-90 carbon microsphere radioembolization. 4. Child-Pugh score ≤7, ECOG performance status <2, and life expectancy >3 months. 5. Disease confined to the liver after systemic assessment. 6. At least one measurable lesion according to mRECIST and RECIST v1.1. 7. Adequate residual normal liver volume and adequate bone marrow, hepatic, renal, and coagulation function. 8. For participants with portal vein tumor thrombus, eligibility must be confirmed by the investigator based on hepatic angiography and 99mTc-MAA hepatic arterial perfusion imaging. 9. Suitable for SIRT based on hepatic vascular evaluation and 99mTc-MAA assessment. 10. Willing to use effective contraception as required by the protocol. 11. Able to understand and comply with the study requirements and willing to provide written informed consent.

Exclusion Criteria:

1. Extrahepatic metastasis, including regional lymph node metastasis. 2. Uncontrolled biliary obstruction or recent biliary infection within 6 months before informed consent. 3. Prior internal or external radiotherapy to the liver or upper abdomen. 4. Anticancer therapy within 30 days before NRT6003 treatment, or small-molecule targeted therapy within 14 days before treatment. 5. Known allergy, intolerance, or contraindication to any study-related drug, contrast agent, anesthetic agent, or excipient. 6. Severe pulmonary dysfunction. 7. Untreated or inadequately treated esophageal or gastric varices considered by the investigator to have a high bleeding risk. 8. Uncontrolled disease or infection that may affect study safety or efficacy, as judged by the investigator. 9. Positive HIV antibody test. 10. 99mTc-MAA imaging or hepatic angiography showing inadequate coverage of target intrahepatic lesions, uncorrectable gastrointestinal shunting, or estimated single-session lung absorbed dose >30 Gy. 11. Pregnant or breastfeeding women. 12. Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.

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: NRT6003 Injection Radioembolization
Participants will receive one session of transarterial selective internal radiation therapy with NRT6003 Injection, a yttrium-90 carbon microsphere product, after hepatic vascular evaluation, 99mTc-MAA simulation, and individualized dosimetry assessment.
Médicament: NRT6003 Injection
NRT6003 Injection contains yttrium-90 carbon microspheres and is administered by transarterial infusion for selective internal radiation therapy. Participants will receive one treatment session only. The administered activity will be determined based on hepatic vascular assessment, 99mTc-MAA simulation, lung shunting assessment, and individualized dosimetry.
Autres noms:
  • TARE
  • SIRT
  • Radiothérapie interne sélective
  • Radioembolisation transartérielle
  • Yttrium-90 Carbon Microspheres
  • Y-90 Carbon Microspheres

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Objective Response Rate (ORR) as Assessed by mRECIST
Délai: Up to 12 months after NRT6003 administration
Objective response rate is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) after treatment with NRT6003 Injection. Tumor response will be assessed according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) at protocol-defined imaging assessment time points.
Up to 12 months after NRT6003 administration
Incidence, Type, and Severity of Adverse Events and Serious Adverse Events
Délai: From hepatic vascular evaluation through 12 months after NRT6003 administration
Safety will be assessed by the incidence, type, severity, seriousness, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs). Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).
From hepatic vascular evaluation through 12 months after NRT6003 administration

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Objective Response Rate (ORR) as Assessed by RECIST v1.1
Délai: Up to 12 months after NRT6003 administration
Objective response rate is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) after treatment with NRT6003 Injection. Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) at protocol-defined imaging assessment time points.
Up to 12 months after NRT6003 administration
Disease Control Rate (DCR) as Assessed by mRECIST and RECIST v1.1
Délai: Up to 12 months after NRT6003 administration
Disease control rate is defined as the proportion of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) after treatment with NRT6003 Injection. DCR will be assessed and summarized separately according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) at protocol-defined imaging assessment time points.
Up to 12 months after NRT6003 administration
Duration of Response (DoR) as Assessed by mRECIST and RECIST v1.1
Délai: From first documented response up to 12 months after NRT6003 administration
Duration of response is defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression or death from any cause, whichever occurs first. DoR will be assessed and summarized separately according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
From first documented response up to 12 months after NRT6003 administration
Progression-Free Survival (PFS) as Assessed by mRECIST and RECIST v1.1
Délai: Up to 12 months after NRT6003 administration
Progression-free survival is defined as the time from NRT6003 administration to the first documented disease progression or death from any cause, whichever occurs first. Disease progression will be assessed and summarized separately according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Up to 12 months after NRT6003 administration
Progression-Free Survival in the Treated Area as Assessed by mRECIST and RECIST v1.1
Délai: Up to 12 months after NRT6003 administration
Progression-free survival in the treated area is defined as the time from NRT6003 administration to the first documented disease progression within the treated area or death from any cause, whichever occurs first. Progression in the treated area will be assessed and summarized separately according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Up to 12 months after NRT6003 administration
Surgical Resection Rate After SIRT
Délai: Up to 12 months after NRT6003 administration
Surgical resection rate is defined as the proportion of participants who undergo surgical resection during the follow-up period after NRT6003 Injection radioembolization. R0/R1 resection status and pathological findings may be summarized when surgical specimens are available.
Up to 12 months after NRT6003 administration

Collaborateurs et enquêteurs

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

Parrainer

Second Affiliated Hospital of Guangzhou Medical University

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 (Estimé)

22 juin 2026

Achèvement primaire (Estimé)

21 décembre 2027

Achèvement de l'étude (Estimé)

21 décembre 2027

Dates d'inscription aux études

Première soumission

15 juin 2026

Première soumission répondant aux critères de contrôle qualité

15 juin 2026

Première publication (Réel)

18 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NRT6003-HCC-IIT

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 .

S'abonner