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Chemotherapy

TACE + SBRT for Liver Cancer

N/A
Waitlist Available
Led By Edgar Ben-Josef, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years old
Meets clinical criteria for eligibility for TACE to the target lesion per Interventional Radiology
Must not have
Contraindication to both contrast enhanced MRI and contrast enhanced CT (i.e. unable to undergo follow-up imaging or SBRT treatment planning)
Complete obstruction of portal venous flow to the segment of liver that includes the target lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether combining two cancer treatments, SBRT and TACE, is effective for patients with HCC awaiting liver transplantation.

Who is the study for?
This trial is for adults over 18 with hepatocellular carcinoma who are on or recommended for a liver transplant list. They should be able to undergo TACE, have Childs' Class A or B7 liver function, and an ECOG performance status of 0 or 1. Pregnant women, those in other treatment studies, with certain medical conditions like active GI ulcers or bleeds, prior upper abdomen radiotherapy or liver treatments are excluded.
What is being tested?
The study is testing if combining two treatments—TACE and SBRT—is effective as a temporary solution (bridging therapy) for patients with liver cancer waiting for a transplant. It's the first study of its kind and aims to enroll 40 patients into each treatment group.
What are the potential side effects?
Possible side effects from TACE may include abdominal pain, fever, nausea; while SBRT could cause fatigue, skin reactions at the treatment site, and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I am eligible for a specific liver cancer treatment as per my radiologist.
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I have liver cancer and am on or recommended for the liver transplant list.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have MRI or CT scans with contrast due to health reasons.
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Blood flow in the vein to part of my liver with the cancer is completely blocked.
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My ascites hasn't improved with medication.
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I have had TACE, RFA, or a liver transplant for my liver lesion.
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I cannot undergo radiotherapy or TACE due to health reasons.
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I am currently pregnant.
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I have had radiation therapy to my upper abdomen or liver.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: B - Tace combined with SBRTExperimental Treatment2 Interventions
B- TACE combined with SBRT (experimental group).
Group II: A -Tace aloneExperimental Treatment1 Intervention
A - TACE alone (control group, current practice and treatment)

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,473 Total Patients Enrolled
1 Trials studying Liver Cancer
18 Patients Enrolled for Liver Cancer
Abramson Cancer Center at Penn MedicineLead Sponsor
413 Previous Clinical Trials
165,174 Total Patients Enrolled
1 Trials studying Liver Cancer
18 Patients Enrolled for Liver Cancer
Loyola UniversityOTHER
160 Previous Clinical Trials
31,379 Total Patients Enrolled

Media Library

Transarterial Chemoembolization (TACE) (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01918683 — N/A
Liver Cancer Research Study Groups: A -Tace alone, B - Tace combined with SBRT
Liver Cancer Clinical Trial 2023: Transarterial Chemoembolization (TACE) Highlights & Side Effects. Trial Name: NCT01918683 — N/A
Transarterial Chemoembolization (TACE) (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01918683 — N/A
~6 spots leftby Dec 2026
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