PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC (Pearl)
14. september 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
40
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: PO-Ting-Lin
- Telefonnummer: 886975362702
- E-post: linpoting0101@gmail.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
1-year progression-free survival (PFS) by mRECIST
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
1-year overall survival (OS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Depth of response (maximum percentage reduction from baseline in the sum of viable target lesion diameters)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. september 2026
Primær fullføring (Antatt)
31. mai 2029
Studiet fullført (Antatt)
31. mai 2029
Datoer for studieregistrering
Først innsendt
25. juli 2026
Først innsendt som oppfylte QC-kriteriene
14. september 2026
Først lagt ut (Faktiske)
18. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 202600872A3
- LHYY001 (Annet stipend/finansieringsnummer: Lin Huang Yueh-Ying Medical Foundation)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
produkt produsert i og eksportert fra USA
Nei
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