Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT05608213

Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2022-11-08

187

Participants Needed

1

Research Sites

212 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • HCC confirmed by histopathology, cytology, or clinical diagnosis
  • Diagnosis of TACE-refractory HCC by Japan Society of Hepatology (2021) criteria
  • Tumor recurrence after surgery or ablation allowed
  • At least one measurable intrahepatic tumor lesion
  • Child-Pugh liver function class A or B
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 3 months
Not Eligible

You will not qualify if you...

  • Presence of cancer spread outside the liver (extrahepatic metastasis)
  • Tumor thrombus in main portal vein or both first left and right portal vein branches
  • Invasion of the vena cava
  • Prior treatment with systemic therapy, immunotherapy, hepatic arterial infusion chemotherapy, or radiotherapy for HCC
  • History of organ or cell transplantation
  • History of bleeding from esophagogastric varices
  • History of hepatic encephalopathy
  • Platelet count below 50 x 10^9/L
  • Prolonged prothrombin time of 4 seconds or more
  • Severe heart, lung, or kidney dysfunction
  • History of other cancers besides HCC

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510260

Actively Recruiting

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Research Team

M

Mingyue Cai, MD

CONTACT

K

Kangshun Zhu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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