PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC (Pearl)
14 września 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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)
Typ studiów
Interwencyjne
Zapisy (Szacowany)
40
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: PO-Ting-Lin
- Numer telefonu: 886975362702
- E-mail: linpoting0101@gmail.com
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
1-year progression-free survival (PFS) by mRECIST
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
1-year overall survival (OS)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Depth of response (maximum percentage reduction from baseline in the sum of viable target lesion diameters)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
30 września 2026
Zakończenie podstawowe (Szacowany)
31 maja 2029
Ukończenie studiów (Szacowany)
31 maja 2029
Daty rejestracji na studia
Pierwszy przesłany
25 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
14 września 2026
Pierwszy wysłany (Rzeczywisty)
18 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
18 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
14 września 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 202600872A3
- LHYY001 (Inny numer grantu/finansowania: Lin Huang Yueh-Ying Medical Foundation)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
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