RecruitingPhase 2NCT04988945

TACE and SBRT Followed by Double Immunotherapy for Downstaging Hepatocellular Carcinoma

Sequential TransArterial Chemoembolization and Stereotactic RadioTherapy Followed by Durvalumab (MEDI4736) and Tremelimumab for Downstaging Hepatocellular Carcinoma for Hepatectomy


Sponsor

The University of Hong Kong

Enrollment

33 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective phase II, single arm mono-institutional study conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of the sequential administration of trans-arterial chemo-embolization (TACE) and stereotactic body radiotherapy (SBRT) with immune checkpoint inhibitors in unresectable hepatocellular carcinoma (HCC) patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combined treatment approach for people with inoperable liver cancer (hepatocellular carcinoma, or HCC) that needs to be "downstaged" — meaning shrunk enough to qualify for a liver transplant. The approach uses arterial chemotherapy (TACE), focused radiation (SBRT), and two immunotherapy drugs to try to shrink the tumor. **You may be eligible if...** - You are 18 or older with confirmed HCC that cannot be surgically removed - Your liver cancer has been diagnosed using standard imaging criteria - You are in good overall health (ECOG 0–1) and weigh over 30 kg - You are being considered for liver transplant downstaging **You may NOT be eligible if...** - Your cancer has spread outside the liver (except in specific, limited circumstances) - Your liver function is too poor to tolerate the treatment - You have active autoimmune disease or are on immune-suppressing medications - You are pregnant or breastfeeding 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

PROCEDURETACE

Procedure of TACE will be standardized.

RADIATIONSBRT

SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists.

DRUGDurvalumab

1500mg Durvalumab administered IV over 60 minutes on Day 1 of each immunotherapy treatment every 4 weeks until disease progression (PD)

DRUGTremelimumab

300mg Tremelimumab administered over 60 minutes on Day 1 of cycle 1.


Locations(2)

Department of Surgery, The University of Hong Kong

Hong Kong, Hong Kong

The University of Hong Kong

Hong Kong, Hong Kong

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NCT04988945


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