RECRUITING

Combination of TATE and PD-1 Inhibitor in Liver Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-center, open-label phase IIA study that investigates the preliminary efficacy of Trans-arterial Tirapazamine Embolization (TATE) treatment of liver cancer followed by a PD-1 checkpoint inhibitor (nivolumab). Patients with two types of cancers will be enrolled, advanced hepatocellular carcinoma (HCC),and metastatic gastric cancer. All enrolled patients need to have liver lesions and have progressed on a prior immune checkpoint inhibitor.

Official Title

Phase IIA Single-Arm Study of Treatment of Patients With Advanced Liver Cancer With a Combination of TATE (Transarterial Tirapazamine Embolization) Followed by an Anti-PD-1 Monoclonal Antibody

Quick Facts

Study Start:2017-07-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03259867

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Ray Lee, MD. PhD
CONTACT
8043341076
ray.lee01@teclison.com
Chiwei Lu, PhD.
CONTACT
chiwei.lu4@teclison.com

Principal Investigator

Nadine Abi-Jaoudeh, MD
PRINCIPAL_INVESTIGATOR
UC Irvine Medical Center

Study Locations (Sites)

University of California, Irvine
Orange, California, 92868
United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Teclison Ltd.

  • Nadine Abi-Jaoudeh, MD, PRINCIPAL_INVESTIGATOR, UC Irvine Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-07-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2017-07-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Hepatocellular carcinoma
  • Immune checkpoint inhibitor
  • Gastric cancer
  • Progression

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma
  • Gastric Cancer