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Anti-tumor antibiotic

TACE + SBRT for Liver Cancer (TACE Trial)

Phase 3
Recruiting
Led By Michael Lock, M.D.
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All intrahepatic disease must be amenable to TACE
All intrahepatic disease must be encompassed within the radiation fields according to protocol criteria.
Must not have
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Severe cirrhosis or liver failure defined as Child Pugh > B7
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether adding a specialized radiation treatment to the standard chemotherapy treatment for liver cancer will help control the cancer better.

Who is the study for?
This trial is for adults with liver cancer, having up to 5 liver lesions and no severe cirrhosis or active hepatitis. They must not have had certain treatments recently, be able to use contraception, and have a life expectancy over 6 months. Those with larger tumors or previous radiation in the same area can't join.
What is being tested?
The study compares standard TACE treatment for liver cancer against TACE combined with SBRT, a precise radiation therapy. It aims to see if adding SBRT better controls the growth of liver tumors after TACE.
What are the potential side effects?
TACE can cause abdominal pain, fever, nausea, and liver problems. SBRT might add side effects like fatigue, skin reactions at the treatment site, and potential damage to nearby organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver cancer can be treated with TACE.
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All my liver cancer can be targeted with radiation.
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I finished chemotherapy at least 2 weeks ago and won't start again for at least 1 week after my next treatment.
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I have liver cancer with specific blood test results and liver condition.
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My scans show liver spots, suggesting cancer spread, but my earlier liver scans were clear.
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I can take care of myself, but I cannot do heavy physical work.
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My liver or bile duct cancer is confirmed by lab tests.
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My liver cancer or liver spread is 25 cm or smaller.
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I am older than 18 years.
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My liver cancer is not lymphoma and has been confirmed by a biopsy.
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My condition cannot be treated with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had radiation in the same area where my current cancer is located.
Select...
My liver is not severely damaged (Child Pugh ≤ B7).
Select...
My health issues do not limit my life expectancy to under 6 months.
Select...
I am not pregnant, nursing, or able to become pregnant and will use birth control during the study.
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I do not have active hepatitis or significant liver failure.
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My liver tumor or metastasis is larger than 25 cm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Time to Intrahepatic Progression
Secondary study objectives
Change in Health related Quality of Life (QOL)
Cost-benefit
Extrahepatic failure
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Transarterial Chemoembolization (TACE)Active Control1 Intervention
Transarterial Chemoembolization (TACE)
Group II: TACE Plus Stereotactic Body Radiation Therapy (SBRT)Active Control1 Intervention
Stereotactic Body Radiation Therapy (SBRT)

Find a Location

Who is running the clinical trial?

CancerCare ManitobaOTHER
28 Previous Clinical Trials
5,512 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
680 Previous Clinical Trials
421,805 Total Patients Enrolled
Michael Lock, M.D.Principal InvestigatorLawson Health Research Institute

Media Library

Transarterial Chemoembolization (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03895359 — Phase 3
Liver Cancer Research Study Groups: Transarterial Chemoembolization (TACE), TACE Plus Stereotactic Body Radiation Therapy (SBRT)
Liver Cancer Clinical Trial 2023: Transarterial Chemoembolization Highlights & Side Effects. Trial Name: NCT03895359 — Phase 3
Transarterial Chemoembolization (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03895359 — Phase 3
~40 spots leftby Jun 2027
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