CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
TACE +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02513199
NCT02513199Phase 2Completed

Assessment of Response of Unresectable Hepatocellular Carcinoma to Combination Chemoembolization and Stereotactic Body Radiation Therapy

Icahn School of Medicine at Mount Sinai·interventional·Posted Jul 31, 2015·Updated Jun 18, 2023

In Brief

A Phase 2 clinical trial evaluating SBRT and TACE for Hepatocellular Carcinoma. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The purpose of this study is to develop better ways to treat liver cancer, known as hepatocellular carcinoma or HCC, while it is still in the liver. Many treatments exist to treat tumors in the liver when they are small but after they grow past a certain size, local therapies such as surgery, Trans-Arterial Chemo Embolization (TACE), or Radiofrequency Ablation (RFA) are not effective. The purpose of this study to test the combination of two known treatments - TACE and Stereotactic Body Radiation Therapy (SBRT) - to be used together to treat larger or difficult to access liver tumors. Each treatment has been shown to work well but has limitations. The study will combine the treatments in an organized sequence and monitor closely how effective this combination controls tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 31, 2015
Enrollment StartNov 1, 2014
Primary CompletionJan 1, 2022
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 10.9 years ago

Interventions

SBRTradiation

Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days.

TACEdrug

two sessions of standard TACE with ethiodol separated by a 4-week interval.