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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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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)

研究类型

介入性

注册 (估计的)

40

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：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.
程序：Partial transarterial chemoembolization (TACE)
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.
其他名称：
  • Partial TACE

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
1-year progression-free survival (PFS) by mRECIST
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
1-year overall survival (OS)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Depth of response (maximum percentage reduction from baseline in the sum of viable target lesion diameters)
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chang Gung Memorial Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月30日

初级完成 (估计的)

2029年5月31日

研究完成 (估计的)

2029年5月31日

研究注册日期

首次提交

2026年7月25日

首先提交符合 QC 标准的

2026年9月14日

首次发布 (实际的)

2026年9月18日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 202600872A3
  • LHYY001 (其他赠款/资助编号：Lin Huang Yueh-Ying Medical Foundation)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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