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Yttrium-90 Carbon Microsphere Radioembolization in Previously Treated Hepatocellular Carcinoma

15. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510260
        • The Second Affiliated Hospital, Guangzhou Medical University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kangshun Zhu, MD
        • Underetterforsker:
          • Jingjun Huang, MD

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Andre navn:
  • TARE
  • SIRT
  • Selektiv intern strålebehandling
  • Transarteriell radioembolisering
  • Yttrium-90 Carbon Microspheres
  • Y-90 Carbon Microspheres

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective Response Rate (ORR) as Assessed by mRECIST
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective Response Rate (ORR) as Assessed by RECIST v1.1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

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 (Antatt)

22. juni 2026

Primær fullføring (Antatt)

21. desember 2027

Studiet fullført (Antatt)

21. desember 2027

Datoer for studieregistrering

Først innsendt

15. juni 2026

Først innsendt som oppfylte QC-kriteriene

15. juni 2026

Først lagt ut (Faktiske)

18. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NRT6003-HCC-IIT

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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