TS-PERIO-02 - ACTIVE, NOT RECRUITING

Study Name
TSPERIO02
ClinicalTrials.gov Identifier (if applicable)
NCT05220722
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Immunotherapy
  • Other Novel Therapy
Study Center
Institution Name
MD Anderson Cancer Center
City
Houston
State
Texas
Country
United States
List additional Institutions (include address, phone number, and website)
Rhode Island Hosptial at Brown
University of Colorado
Columbia University
Study Contacts
Principal Investigator
Dr. Milind Javle
P.I. Phone
(713) 792-2828
P.I. Email
mjavle@mdanderson.org
List additional Principal Investigators (include phone number and email)
Dr. Khaldoun Almhanna, 401-606-4694, Kalmhanna@Lifespan.org
Dr. Karie Runcie, kr2836@cumc.columbia.edu
Dr. Sarah Davis, SARAH.DAVIS@CUANSCHUTZ.EDU
Coordinator Email
GIClinicalTrials@mdanderson.org
List additional Study Coordinators (include phone number and email)
RIH: Shoira Saliev Ahunbaev, 401-444-4189, 336121@lifespan.org
Colorado: McKenna Russen, (720) 848-8785, MCKENNA.RUSSEN@CUANSCHUTZ.EDU
Columbia: Nadine Kuriakose, 212-304-5530, nk2947@cumc.columbia.edu
OVERVIEW – in layman’s terms (150 words max)
In this study, a new delivery approach is being tested for patients with HCC and ICC. These tumors are often located in different parts of the liver. To get the drug to all tumors within your liver, this study is testing the delivery of an investigational drug called SD-101 with a TriNav device. SD-101 may stimulate the immune system.
Enrollment
15-90 patients
Study Start Date
05/03/2022
Estimated Completion Date
01/01/2025
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • Immune cells may help to kill tumor cells. SD-101 will be given alone and in combination with checkpoint inhibitors. The TriNav device involves routine techniques by interventional radiologists.