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

NCT07827807 | Not Yet Recruiting Phase 2

• 2 other identifiers: 202600872A3LHYY001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Hepatocellular Carcinoma

Keywords

HCC; Liver tumor; TACE; lenvatinib

Outcome Measures

Primary Outcomes (1)

• 1-year progression-free survival (PFS) by mRECIST

  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

Secondary Outcomes (8)

• 1-year overall survival (OS)

  1 year after start of study treatment

• Objective response rate (ORR) by mRECIST

  Up to 12 months after start of study treatment

• Objective response rate (ORR) by RECIST v1.1

  Up to 12 months after start of study treatment

• Disease control rate (DCR) by mRECIST

  Up to 12 months after start of study treatment

• Disease control rate (DCR) by RECIST v1.1

  Up to 12 months after start of study treatment

Other Outcomes (3)

• Depth of response (maximum percentage reduction from baseline in the sum of viable target lesion diameters)

  Up to 12 months after start of study treatment

• Change from baseline in immune cell subset frequencies assessed by multiparametric flow cytometry

  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

  Baseline, within 24 hours before TACE, within 48 hours after TACE, Week 12, and Week 24

Study Arms (1)

Partial TACE Enhancing Anti-tumor Response with Lenvatinib in unresectable HCC

EXPERIMENTAL

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.

Drug: Lenvatinib; Procedure: Partial transarterial chemoembolization (TACE)

Interventions

Lenvatinib DRUG

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.

Partial TACE Enhancing Anti-tumor Response with Lenvatinib in unresectable HCC

Partial transarterial chemoembolization (TACE) PROCEDURE

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.

Also known as: Partial TACE

Partial TACE Enhancing Anti-tumor Response with Lenvatinib in unresectable HCC

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

PO-Ting-Lin

CONTACT

886975362702; linpoting0101@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: September 18, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: September 18, 2026

Record last verified: 2026-07