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

NCT03895359 | Recruiting Phase 3

• 1 other identifier: TACE
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Overall Survival-number of patients alive censored for deaths by any cause

  At 2 years from start of treatment

• Time to Intrahepatic Progression

  This will be measured using the modified RECIST (Response evaluation criteria in solid tumors) criteria

  Pre-treatment, at 1 month and 3 month follow-up, and at follow-up every 3 months up to 2 years

Secondary Outcomes (12)

• Measurement of Response Rate

  The sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor.

• Local Failure

  5 years

• Extrahepatic failure

  Pre-treatment, at 1 month and 3 month follow-up, and at follow-up every 3 months up to 2 years

• Time to intrahepatic progression

  Pre-treatment, at 1 month and 3 month follow-up, and at follow-up every 3 months up to 2 years

• Radiation Therapy Overall Toxicity Assessment

  Weekly during treatment, 1 and 3 month follow-up, and every 3 months thereafter up to 2 years

Study Arms (2)

Transarterial Chemoembolization (TACE)

ACTIVE COMPARATOR

Transarterial Chemoembolization (TACE)

Drug: Transarterial Chemoembolization

TACE Plus Stereotactic Body Radiation Therapy (SBRT)

ACTIVE COMPARATOR

Stereotactic Body Radiation Therapy (SBRT)

Radiation: Stereotactic Body Radiation

Interventions

Stereotactic Body Radiation RADIATION

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

TACE Plus Stereotactic Body Radiation Therapy (SBRT)

Transarterial Chemoembolization DRUG

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.

Also known as: TACE

Transarterial Chemoembolization (TACE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• CancerCare Manitoba: collaborator

Study Sites (1)

London Health Sciences Centre, London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Michael Lock, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Lock, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 29, 2019
• Study Start: May 27, 2019
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)