Recruiting
Phase 3

TACE vs. SBRT

Sponsor:

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

Code:

NCT03895359

Conditions

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Body Radiation

Transarterial Chemoembolization

Study Details

Brief summary:

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

Hepatocellular Carcinoma

Study ID

NCT03895359

Start date

May 27, 2019

Status verified date

Mar, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Primary hepatobiliary cancer confirmed pathologically
  • Non - lymphoma liver metastases confirmed pathologically
  • Radiographic liver lesions most consistent with metastases, in a patient with known pathologically proven non - lymphoma cancer and a previously negative CT or MRI of the liver
  • Hepatocellular carcinoma diagnosed with vascular enhancement of the lesion consistent with hepatocellular carcinoma, and with an elevated AFP, in the setting of cirrhosis or chronic hepatitis.
  • ≤ 5 liver lesions measurable on a contrast - enhanced liver CT or MRI performed within 90 days prior to study entry.
  • Primary liver lesion or liver metastases measuring ≤ 25 cm.
  • Extrahepatic cancer is permitted if liver involvement is judged to be life - limiting.
  • All intrahepatic disease must be encompassed within the radiation fields according to protocol criteria.
  • Patient must be judged medically or surgically unresectable
  • Zubrod Performance Scale = 0 - 3
  • Age > 18
  • All intrahepatic disease must be amenable to TACE
  • Previous liver resection or ablative therapy is permitted.
  • Chemotherapy must be completed at least 2 weeks prior to radiation therapy or TACE, and not planned to be administered for at least 1 week (for anthracyclines at least 4 weeks) after completion of treatment.
  • Life expectancy > 6 months.
  • Women of childbearing potential and male participants must practice adequate contraception.
  • Patient must sign study specific informed consent prior to study entry.

Pretreatment Evaluations Required for Eligibility:

  • A complete history and general physical examination.
  • CBC, INR, Total bilirubin, albumin, alkaline phosphatase, ALT, AST within 4 weeks prior to study entry. Appropriate levels are as follows:
  • Absolute neutrophil count (ANC) ≥ 1,500 cells / mm3
  • Platelets ≥ 70,000 cells / mm3
  • Hemoglobin ≥ 8.0 g / dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g / dl is acceptable.)
  • Total bilirubin < 3 mg / dL
  • Prothrombin time / INR < 2 (if not on anticoagulants)
  • Albumin ≥ 28 g / L
  • AST and ALT < 10 times ULN

Exclusion Criteria:

  • Severe cirrhosis or liver failure defined as Child Pugh > B7
  • Primary liver tumor or liver metastasis > 25 cm in maximal dimension.
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity, defined as limiting the patients life to less than 6 months
  • Active hepatitis or clinically significant liver failure.
  • Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be teratogenic.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Transarterial Chemoembolization (TACE)

Transarterial Chemoembolization (TACE)

active comparator: TACE Plus Stereotactic Body Radiation Therapy (SBRT)

Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation

For patients randomized to the SMRT arm, SBRT is to be delivered over 5 fractions delivered over 5 to 15 days.

Transarterial Chemoembolization

Transarterial chemoembolization is a standard treatment for patients with hepatocellular carcinoma (liver cancer). Chemotherapy is injected into the arteries of the liver and liver cancer.

Primary outcome measure

  • Overall Survival [ Time Frame: At 2 years from start of treatment ]
  • Time to Intrahepatic Progression [ Time Frame: Pre-treatment, at 1 month and 3 month follow-up, and at follow-up every 3 months up to 2 years ]

Central Contacts and Locations

Central contacts

Michael Lock, M.D.

519-685-8650michael.lock@lhsc.on.ca

Locations

London Health Sciences Centre, London Regional Cancer Program

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Michael Lock, M.D.

519-685-8650michael.lock@lhsc.on.ca

More Information

Sponsor

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

Last update posted

Mar 11, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-03-11.