Clinical trial · Interventional
PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Partial transarterial chemoembolization (TACE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Partial TACE Enhancing Anti-tumor Response with Lenvatinib in unresectable HCC
- description
- 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.
- interventionNames
- Drug: Lenvatinib
- Procedure: Partial transarterial chemoembolization (TACE)
Primary outcomes (1)
- measure
- 1-year progression-free survival (PFS) by mRECIST
- timeFrame
- 1 year after start of study treatment
- description
- 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.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available