NCT06904196

Brief Summary

This study is conducted to evaluate the efficacy and safety of lenvatinib plus SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
36mo left

Started Apr 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Apr 2025Mar 2029

First Submitted

Initial submission to the registry

March 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

April 29, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

March 25, 2025

Last Update Submit

April 28, 2025

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

hepatocellular carcinomaLenvatinibYttrium-90

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST

    3 years

Secondary Outcomes (6)

  • Disease control rate (DCR)

    3 years

  • Progression free survival (PFS)

    3 years

  • Time to response (TTR)

    3 years

  • Duration of response (DOR)

    3 years.

  • Overall survival (OS)

    4 years.

  • +1 more secondary outcomes

Study Arms (2)

Len+SIRT

EXPERIMENTAL

Lenvatinib plus SIRT

Combination Product: Lenvatinib plus SIRT

LEN

ACTIVE COMPARATOR

Lenvatinib alone

Drug: Lenvatinib

Interventions

Lenvatinib plus SIRTCOMBINATION_PRODUCT

Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD will be started at 3-7 days after the first SIRT.

Len+SIRT
LenvatinibDRUG

Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD.

LEN

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed or clinically diagnosed HCC
  • Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)
  • Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
  • At least one measurable intrahepatic target lesion
  • Child-Pugh class A/B
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Tumor extent \<70% liver occupation
  • Candidates for SIRT must be confirmed suitable for SIRT after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
  • Adequate organ and hematologic function with platelet count ≥50×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, albumin ≥28 g/L, total bilirubin ≤3× ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
  • Life expectancy of at least 3 months

You may not qualify if:

  • Extrahepatic metastasis
  • Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
  • Vena cava invasion
  • Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC
  • History of organ and cell transplantation
  • History of esophageal or gastric variceal bleeding
  • History of hepatic encephalopathy
  • History of other malignancies
  • Human immunodeficiency virus infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinibSirtuins

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Group III Histone DeacetylasesHistone DeacetylasesAmidohydrolasesHydrolasesEnzymesEnzymes and CoenzymesADP Ribose TransferasesPentosyltransferasesGlycosyltransferasesTransferasesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Mingyue Cai, Dr.

    Second Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR

Central Study Contacts

Mingyue Cai, Dr.

CONTACT

+86-20-34156205cai020@yeah.net

Mingyue Cai, Dr.

CONTACT

+86-20-34156205zhksh010@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 1, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2029

Last Updated

April 29, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)