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Yttrium-90 Carbon Microsphere Radioembolization in Previously Treated Hepatocellular Carcinoma

2026年6月15日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

20

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Jingjun Huang, MD
  • 電話番号：+86-20-34156205
  • メール：junooi@foxmail.com

研究場所

  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国、510260
        • The Second Affiliated Hospital, Guangzhou Medical University
        • コンタクト：
        • 主任研究者：
          • Kangshun Zhu, MD
        • 副調査官：
          • Jingjun Huang, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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.
他の名前：
  • タレ
  • SIRT
  • 選択的内部放射線療法
  • 経動脈的放射線塞栓術
  • Yttrium-90 Carbon Microspheres
  • Y-90 Carbon Microspheres

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR) as Assessed by mRECIST
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR) as Assessed by RECIST v1.1
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Second Affiliated Hospital of Guangzhou Medical University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月22日

一次修了 (推定)

2027年12月21日

研究の完了 (推定)

2027年12月21日

試験登録日

最初に提出

2026年6月15日

QC基準を満たした最初の提出物

2026年6月15日

最初の投稿 (実際)

2026年6月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月18日

QC基準を満たした最後の更新が送信されました

2026年6月15日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • NRT6003-HCC-IIT

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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