MedTrace Logo

Randomized Phase II Trial of Chemoembolization and Sorafenib

NCT02908165 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-01-10

No results posted yet for this study

Summary

The study will be a single-center, randomized Phase II study of conventional TACE in combination with sorafenib, given either continuously or sequentially, in patients with unresectable HCC. The primary variables will be tumor response (by MR Imaging) and plasma VEGF levels, prior to and after cTACE.

Conditions

Interventions

DRUG

conventional TACE in combination with sorafenib, administered on a continuous schedule

Patients assigned to Group A will begin sorafenib on a continuous schedule starting at 400mg BID from Cycle 1 Day 1, one week prior to cTACE treatment on Cycle 1 Day 8. After week 6, cTACE will be provided on demand (as needed, up to 4 treatments total in the first 4 cycles) at week 2 in subsequent cycles, and sorafenib will continue to be administered. Patients will be allowed to undergo dose adjustments of sorafenib as long as it remains above the ¼ dose (400mg QOD).

DRUG

conventional TACE in combination with sorafenib, administered on a sequential schedule

Patients assigned to Group B will undergo cTACE up to 4 treatments within the first 4 cycles as needed prior to starting sorafenib. After it is determined that no further TACE treatment is necessary (via imaging and clinical assessment on follow-up), administration of sorafenib will begin on Day 1 of the following cycle. Dosing will begin at 400mg BID and maintained continuously provided no unmanageable toxicities develop, with follow-up assessments performed on week 6 of every 1-2 cycles as needed. Patients in Group B will also be allowed to undergo dose adjustments of sorafenib as long as it remains above the ¼ dose (400mg QOD).

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Jeff Geschwind · Professor of Radiology and Biomedical Imaging

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02908165 on ClinicalTrials.gov