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PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC (Pearl)

14 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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)

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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.
Procedure: 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.
Andere namen:
  • Partial TACE

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
1-year progression-free survival (PFS) by mRECIST
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
1-year overall survival (OS)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Depth of response (maximum percentage reduction from baseline in the sum of viable target lesion diameters)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chang Gung Memorial Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 september 2026

Primaire voltooiing (Geschat)

31 mei 2029

Studie voltooiing (Geschat)

31 mei 2029

Studieregistratiedata

Eerst ingediend

25 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 september 2026

Eerst geplaatst (Werkelijk)

18 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 september 2026

Laatste update ingediend die voldeed aan QC-criteria

14 september 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 202600872A3
  • LHYY001 (Ander subsidie-/financieringsnummer: Lin Huang Yueh-Ying Medical Foundation)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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