RecruitingPhase 2NCT06904196

Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC

Lenvatinib Combined With Yttrium-90 Selective Internal Radiation Therapy (SIRT) Versus Lenvatinib Alone in TACE-Refractory Hepatocellular Carcinoma: A Prospective Non-Randomized Controlled Study


Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

78 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments in people with liver cancer (HCC) that has stopped responding to a common procedure called TACE (a procedure that delivers chemotherapy directly into the tumor's blood supply): one group gets lenvatinib (a targeted drug) plus radiation delivered through tiny beads injected into the liver (SIRT), while the other gets lenvatinib alone. **You may be eligible if...** - You have been diagnosed with liver cancer (HCC) - Your cancer has stopped responding to TACE treatment - You have at least one measurable tumor in the liver - Your liver function is preserved (Child-Pugh A or B) - Your general health is good (ECOG 0–1) - Your tumor takes up less than 70% of the liver - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread outside the liver - You have serious liver dysfunction - You have had prior treatment with lenvatinib or similar targeted drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTLenvatinib plus SIRT

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

DRUGLenvatinib

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


Locations(1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT06904196


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