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

14. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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)

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: 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.
Verfahren: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
1-year progression-free survival (PFS) by mRECIST
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
1-year overall survival (OS)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Depth of response (maximum percentage reduction from baseline in the sum of viable target lesion diameters)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Chang Gung Memorial Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. September 2026

Primärer Abschluss (Geschätzt)

31. Mai 2029

Studienabschluss (Geschätzt)

31. Mai 2029

Studienanmeldedaten

Zuerst eingereicht

25. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. September 2026

Zuerst gepostet (Tatsächlich)

18. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. September 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 202600872A3
  • LHYY001 (Andere Zuschuss-/Finanzierungsnummer: Lin Huang Yueh-Ying Medical Foundation)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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