PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC (Pearl)
2026년 9월 14일 업데이트: 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.
연구 개요
상세 설명
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)
연구 유형
중재적
등록 (추정된)
40
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: PO-Ting-Lin
- 전화번호: 886975362702
- 이메일: linpoting0101@gmail.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
1-year progression-free survival (PFS) by mRECIST
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
1-year overall survival (OS)
기간: 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.
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1 year after start of study treatment
|
|
Objective response rate (ORR) by mRECIST
기간: 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.
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Up to 12 months after start of study treatment
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Objective response rate (ORR) by RECIST v1.1
기간: 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
기간: 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
기간: 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
기간: 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.
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Up to 12 months after start of study treatment
|
|
Incidence of hepatic decompensation
기간: 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.
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Within 30 days after treatment
|
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Incidence of treatment-emergent adverse events
기간: From first dose of study treatment up to 30 days after the last dose
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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
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depth of response (maximum percentage reduction from baseline in the sum of viable target lesion diameters)
기간: 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
|
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Change from baseline in immune cell subset frequencies assessed by multiparametric flow cytometry
기간: 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.
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Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24
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Change from baseline in immune cell composition assessed by single-cell RNA sequencing
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 30일
기본 완료 (추정된)
2029년 5월 31일
연구 완료 (추정된)
2029년 5월 31일
연구 등록 날짜
최초 제출
2026년 7월 25일
QC 기준을 충족하는 최초 제출
2026년 9월 14일
처음 게시됨 (실제)
2026년 9월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 14일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 202600872A3
- LHYY001 (기타 보조금/기금 번호: Lin Huang Yueh-Ying Medical Foundation)
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아니
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