Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT03895359

Transarterial Chemoembolization (TACE) Versus TACE Plus Stereotactic Body Radiation Therapy (SBRT) in Liver Carcinoma

Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-03-11

128

Participants Needed

1

Research Sites

418 weeks

Total Duration

On this page

Sponsors

L

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

C

CancerCare Manitoba

Collaborating Sponsor

AI-Summary

What this Trial Is About

Trans-arterial chemoembolization (TACE) is a standard treatment for patients with hepatocellular carcinoma (also called liver cancer). This is where chemotherapy is injected into the arteries of the liver and liver cancer. Unfortunately, the tumour grows after TACE in many patients. A new treatment using a specialized radiation procedure called Stereotactic ablative body radiotherapy (SBRT) may increase the chance to control liver cancer. SBRT allows radiation treatments to be focused more precisely, and be delivered more accurately than with older treatments. The purpose of this study is to find out if TACE alone versus TACE plus SBRT is better for you and your liver cancer.

CONDITIONS

Official Title

Transarterial Chemoembolization (TACE) Versus TACE Plus Stereotactic Body Radiation Therapy (SBRT) in Liver Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary hepatobiliary cancer confirmed by pathology
  • Non-lymphoma liver metastases confirmed by pathology
  • Liver lesions consistent with metastases on imaging, in a patient with known non-lymphoma cancer
  • Hepatocellular carcinoma diagnosed by imaging and elevated AFP in cirrhosis or chronic hepatitis
  • Up to 5 measurable liver lesions on contrast-enhanced CT or MRI within 90 days before study entry
  • Liver lesion or metastases measuring 25 cm or less
  • Extrahepatic cancer allowed if liver disease is life-limiting
  • All liver tumors must be included in radiation fields as per protocol
  • Medically or surgically unresectable
  • Zubrod Performance Scale 0 to 3
  • Age over 18
  • All intrahepatic disease must be suitable for TACE
  • Previous liver surgery or ablative therapy allowed
  • Chemotherapy completed at least 2 weeks before radiation or TACE and not planned for at least 1 week after treatment
  • Life expectancy greater than 6 months
  • Women of childbearing potential and men must use effective contraception
  • Signed informed consent prior to entry
  • Required pretreatment evaluations including physical exam and lab tests meeting specific blood count and liver function levels
Not Eligible

You will not qualify if you...

  • Severe cirrhosis or liver failure defined as Child Pugh greater than B7
  • Liver tumor or metastasis larger than 25 cm
  • Prior radiotherapy overlapping study cancer region
  • Severe, active illness limiting life expectancy to less than 6 months
  • Active hepatitis or significant liver failure
  • Pregnancy, nursing, or unwillingness/inability to use contraception if applicable

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

London Health Sciences Centre, London Regional Cancer Program

London, Ontario, Canada, N6A 5W9

Actively Recruiting

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Research Team

M

Michael Lock, M.D.

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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