Radiomics Subtyping to Guide Surgery vs. Maintenance Therapy After HCC Downstaging
A Retrospective Radiomics-Based Subtyping Study to Guide Post-Downstaging Treatment Selection in Patients With Unresectable Hepatocellular Carcinoma Following TACE Plus Lenvatinib and Anti PD-1
The goal of this observational study is to learn about the long-term treatment outcomes for patients with initially unresectable hepatocellular carcinoma (HCC) who achieve successful downstaging with the combination therapy of TACE, lenvatinib, and a PD-1 inhibitor. The main questions it aims to answer are:
Can distinct disease subtypes be identified in successfully downstaged patients using radiomics and clinical data?
Do these different subtypes show significant differences in long-term outcomes, such as recurrence-free survival and overall survival, after undergoing either curative-intent surgical resection or continuing maintenance therapy?
Based on the identified subtypes, can the investigators objectively determine which patients are more suitable for surgical resection and which patients may benefit more from continued maintenance therapy after successful downstaging?
The study will include patients who have already undergone the combination therapy as part of their regular medical care, successfully achieved tumor downstaging (making the tumor technically resectable), and subsequently received either surgical resection or continued maintenance treatment. Researchers will retrospectively analyze their existing clinical and imaging data to compare long-term outcomes between these two treatment paths based on their identified disease subtype.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510280
- ZhuJiang Hospital of Southern Medical University
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Guangzhou、Guangdong、中国、510080
- The First Affiiated Hospital of Sun Yat-sen University
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参加基準
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients diagnosed with hepatocellular carcinoma (HCC) based on clinical or pathological criteria;
- Barcelona Clinic Liver Cancer (BCLC) stage B or C, assessed as unresectable by surgical evaluation; Underwent treatment with TACE combined with lenvatinib and a PD-1 inhibitor, after which the tumor was re-evaluated and deemed resectable by surgical assessment;
- Following the achievement of surgical resectability criteria, patients subsequently underwent either R0 surgical resection or continued treatment with TACE combined with lenvatinib and a PD-1 inhibitor;
- Liver function classified as Child-Pugh Class A or B, or achieved this standard after medical treatment;
- Performance status (PS) score of 0 or 1.
Exclusion Criteria:
- Patients with unclear diagnoses or those with concurrent other malignancies.
- For patients in the downstaging surgery group: Those who underwent non-R0 resection or received additional anti-tumor therapies postoperatively.
- For patients in the maintenance treatment group: Those who received anti-tumor therapies other than TACE/lenvatinib/PD-1 inhibitors.
- Liver function classified as Child-Pugh Class C or above, unresponsive to hepatoprotective therapy.
- Patients with severe infections, such as respiratory, biliary tract, or abdominal infections.
- Patients with severe underlying diseases, particularly immune-related disorders.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Maintenance group
This group consists of patients with initially unresectable hepatocellular carcinoma (HCC) who, after successful downstaging achieved through the combination therapy of Transarterial Chemoembolization (TACE), lenvatinib, and a PD-1 inhibitor, continued with the same non-surgical, maintenance treatment regimen instead of undergoing surgical resection.
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This intervention describes the non-surgical maintenance therapy for patients in the Maintenance Group after successful downstaging.
It consists of continuing the same doses of lenvatinib and PD-1 inhibitor that were administered during the downstaging phase, combined with on-demand TACE performed only upon imaging or biomarker evidence of intrahepatic progression.
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Liver Resection group
This group consists of patients with initially unresectable hepatocellular carcinoma (HCC) who, after achieving successful downstaging through the combination therapy of Transarterial Chemoembolization (TACE), lenvatinib, and a PD-1 inhibitor, underwent curative-intent surgical resection (R0 resection) as their subsequent treatment.
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This intervention consists of curative-intent surgical resection of hepatocellular carcinoma (HCC) performed after successful downstaging achieved through prior TACE combined with lenvatinib and PD-1 inhibitor therapy.
The procedure aims to remove all visible and radiologically responsive tumor tissue to achieve a pathologically confirmed R0 resection margin.
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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 |
|---|---|---|
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Recurrence free survival
時間枠：From date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months
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Time interval from date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months
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From date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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全生存期間
時間枠：初期治療開始日からいずれかの原因による死亡日までの期間を、最初に発生した方で評価し、最大24ヶ月まで評価
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最初の治療開始日から、いずれか早い方のあらゆる原因による死亡日までの時間間隔を、最長24か月間評価
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初期治療開始日からいずれかの原因による死亡日までの期間を、最初に発生した方で評価し、最大24ヶ月まで評価
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協力者と研究者
捜査官
- 主任研究者：Wenzhe Fan, Dr.、First Affiliated Hospital, Sun Yat-Sen University
- 主任研究者：Shunjun Fu, Dr.、Southern Medical University, China
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- 2026-KY-180-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
米国FDA規制機器製品の研究
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