NCT05608213

Brief Summary

This study is conducted to evaluate the efficacy and safety of lenvatinib plus iodine-125 seed brachytherapy (Len-I) 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
187

participants targeted

Target at P25-P50 for phase_3

Timeline
4mo left

Started Nov 2022

Typical duration for phase_3

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 Progress92%
Nov 2022Dec 2026

First Submitted

Initial submission to the registry

November 2, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

4 years

First QC Date

November 2, 2022

Last Update Submit

November 2, 2022

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

Hepatocellular CarcinomaLenvatinibiodion-125 seed

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    The time from date of randomization to death due to any cause.

    4 years

Secondary Outcomes (5)

  • Progression free survival (PFS)

    4 years

  • Time to Progression (TTP)

    4 years

  • Objective response rate (ORR)

    4 years

  • Disease control rate (DCR)

    4 years

  • Adverse Events (AEs)

    4 years

Study Arms (2)

Len-I

EXPERIMENTAL
Procedure: Lenvatinib Plus I-125 Seed Brachytherapy

Len

ACTIVE COMPARATOR
Drug: Lenvatinib

Interventions

Lenvatinib Plus I-125 Seed BrachytherapyPROCEDURE

Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be administered to the patients. Iodion-125 seeds will be implanted into the the target lesions (viable intrahepatic tumor and/or vascular tumor thrombus) under CT guidance according to the pre-operative planning within 7 days after lenvatinib administration. Iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

Len-I
LenvatinibDRUG

Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be administered to the patients.

Len

Eligibility Criteria

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

You may qualify if:

  • HCC confirmed by histopathology and/or cytology, or diagnosed clinically
  • 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
  • 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 branch of portal vein
  • Vena cava invasion
  • Patients who received prior systemic therapy, immunotherapy, hepatic arterial infusion chemotherapy (HAIC) or radiotherapy for HCC
  • History of organ and cell transplantation
  • History of bleeding from esophagogastric varices
  • History of hepatic encephalopathy
  • Hematologic examination: platelets \<50×10\^9/L
  • Prothrombin time prolongation ≥ 4s
  • Severe organ (heart, lung, kidney) dysfunction
  • History of malignancy other than HCC

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

lenvatinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mingyue Cai, MD

CONTACT

+86-20-34156205cai020@yeah.net

Kangshun Zhu, MD

CONTACT

+86-20-34156205zhksh010@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 8, 2022

Study Start

November 2, 2022

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 8, 2022

Record last verified: 2022-11

Locations

CN(1)