PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC (Pearl)
2026年9月14日 更新者：Chang Gung Memorial Hospital
This is a single-arm, open-label, phase II clinical trial.
Patients with unresectable hepatocellular carcinoma (HCC) who are eligible for lenvatinib treatment will receive partial transarterial chemoembolization (TACE) targeting up to two liver segments containing the largest tumor volume or lesions at risk of rupture, in combination with standard lenvatinib therapy.
The partial TACE approach is designed as a liver-function-sparing technique that limits ischemic territory while preserving hepatic reserve.
調査の概要
詳細な説明
Primary objective:
-1-year progression-free survival (PFS) by mRECIST
Secondary objectives:
- 1-year overall survival (OS)
- Objective response rate (ORR) and disease control rate (DCR) per RECIST v1.1 and mRECIST
- Incidence of hepatic decompensation within 30 days after treatment (defined as: bilirubin > 3 mg/dL, new or worsened ascites, or hepatic encephalopathy)
- Duration of response (DOR)
Exploratory Endpoints:
- Depth of response (DpR)
- Immune profile changes from baseline (assessed by multiparametric flow cytometry and single-cell RNA sequencing)
研究の種類
介入
入学 (推定)
40
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：PO-Ting-Lin
- 電話番号：886975362702
- メール：linpoting0101@gmail.com
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:
Diagnosis of HCC confirmed by histology/cytology or typical imaging features, unsuitable for surgical resection or liver transplantation
- Age ≥ 20 years at the time of signing informed consent
- ECOG performance status 0-1
- BCLC stage B or C (without main portal vein thrombosis)
- Child-Pugh score 5-7 (Class A or B7) within 28 days of registration
- Adequate bone marrow, liver, and renal function
- Blood pressure adequately controlled
- Ability to understand and sign written informed consent
Exclusion Criteria:
Prior systemic therapy for HCC
- Main portal vein thrombosis
- Prior locoregional therapy within 4 weeks
- Uncontrolled hypertension
- Clinically significant cardiovascular disease within 6 months
- Pregnancy or breastfeeding
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：Partial TACE Enhancing Anti-tumor Response with Lenvatinib in unresectable HCC
Lenvatinib: Oral administration at 12 mg once daily (body weight ≥ 60 kg) or 8 mg once daily (body weight < 60 kg). Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal. Partial TACE: Performed within 4 weeks after starting lenvatinib. |
Oral lenvatinib 12 mg once daily for body weight 60 kg or greater, or 8 mg once daily for body weight less than 60 kg.
Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.
Transarterial chemoembolization targeting up to two liver segments containing the largest tumor volume or lesions at risk of rupture, performed within 4 weeks after starting lenvatinib.
This liver-function-sparing approach limits the ischemic territory in order to preserve hepatic reserve.
他の名前：
|
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 |
|---|---|---|
|
1-year progression-free survival (PFS) by mRECIST
時間枠：1 year after start of study treatment
|
Percentage of participants alive and free of disease progression at 1 year.
Progression-free survival is measured from the start date of study treatment to the date of first documented disease progression according to modified RECIST (mRECIST) or death from any cause, whichever occurs first.
|
1 year after start of study treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
1-year overall survival (OS)
時間枠：1 year after start of study treatment
|
Percentage of participants alive at 1 year.
Overall survival is measured from the start date of study treatment to the date of death from any cause.
|
1 year after start of study treatment
|
|
Objective response rate (ORR) by mRECIST
時間枠：Up to 12 months after start of study treatment
|
Percentage of participants with a best overall response of confirmed complete response or partial response, as assessed by modified RECIST (mRECIST).
Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment; a first objective response is confirmed by a second imaging assessment 4 weeks later.
|
Up to 12 months after start of study treatment
|
|
Objective response rate (ORR) by RECIST v1.1
時間枠：Up to 12 months after start of study treatment
|
Percentage of participants with a best overall response of confirmed complete response or partial response, as assessed by RECIST version 1.1.
Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment; a first objective response is confirmed by a second imaging assessment 4 weeks later.
|
Up to 12 months after start of study treatment
|
|
Disease control rate (DCR) by mRECIST
時間枠：Up to 12 months after start of study treatment
|
Percentage of participants with a best overall response of confirmed complete response, partial response, or stable disease, as assessed by modified RECIST (mRECIST).
Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment.
|
Up to 12 months after start of study treatment
|
|
Disease control rate (DCR) by RECIST v1.1
時間枠：Up to 12 months after start of study treatment
|
Percentage of participants with a best overall response of confirmed complete response, partial response, or stable disease, as assessed by RECIST version 1.1.
Tumor response is assessed by CT or MRI every 12 weeks from the start of study treatment.
|
Up to 12 months after start of study treatment
|
|
Duration of response (DOR) by mRECIST
時間枠：Up to 12 months after start of study treatment
|
Time from the date of first documented objective response (complete or partial response) to the date of first documented disease progression, as assessed by modified RECIST (mRECIST).
Reported in months.
|
Up to 12 months after start of study treatment
|
|
Incidence of hepatic decompensation
時間枠：Within 30 days after treatment
|
Percentage of participants with hepatic decompensation within 30 days after treatment.
Hepatic decompensation is defined as any of the following: total bilirubin greater than 3 mg/dL, new or worsened ascites, or hepatic encephalopathy.
|
Within 30 days after treatment
|
|
Incidence of treatment-emergent adverse events
時間枠：From first dose of study treatment up to 30 days after the last dose
|
Number of participants with treatment-emergent adverse events and serious adverse events, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
From first dose of study treatment up to 30 days after the last dose
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Depth of response (maximum percentage reduction from baseline in the sum of viable target lesion diameters)
時間枠：Up to 12 months after start of study treatment
|
Maximum percentage reduction from baseline in the sum of viable target lesion diameters, as assessed by modified RECIST (mRECIST).
Reported as percentage change from baseline.
|
Up to 12 months after start of study treatment
|
|
Change from baseline in immune cell subset frequencies assessed by multiparametric flow cytometry
時間枠：Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24
|
Change from baseline in the frequencies of peripheral blood immune cell subsets measured by multiparametric flow cytometry, including CD4+ and CD8+ T cells, regulatory T cells, natural killer cells, mucosal-associated invariant T cells, and myeloid populations, together with the activation and exhaustion markers PD-1, TIM-3, HLA-DR, and CD38.
Reported as percentage of live cells.
|
Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24
|
|
Change from baseline in immune cell composition assessed by single-cell RNA sequencing
時間枠：Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24
|
Change from baseline in immune cell composition measured by single-cell RNA sequencing of peripheral blood mononuclear cells and tissue samples, reported as percentage of sequenced cells assigned to each annotated immune cell cluster.
|
Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24
|
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。
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9月30日
一次修了 (推定)
2029年5月31日
研究の完了 (推定)
2029年5月31日
試験登録日
最初に提出
2026年7月25日
QC基準を満たした最初の提出物
2026年9月14日
最初の投稿 (実際)
2026年9月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年9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9月14日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。