Combination of TATE and PD-1 Inhibitor in Liver Cancer
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.
Conditions:
🦠 Hepatocellular Carcinoma 🦠 Gastric Cancer
🗓️ Study Start (Actual) 1 July 2017
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 54
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Orange, California, United States
📍 Oklahoma City, Oklahoma, United States
📍 Milwaukee, Wisconsin, United States

📋 Eligibility Criteria

Description

  • 1. Patients with a confirmed diagnosis of (1) advanced HCC or (2) metastatic gastric cancer.
  • 2. Patients between ages 18 and 80
  • 3. If HCC patients, they should have progressive disease (PD) on an immune therapy for advanced HCC. For patients with metastatic gastric cancer, they should have failed at least one line of systemic chemotherapy and an immune checkpoint inhibitor.
  • 4. Patients with liver tumor lesions with at least one with a diameter of 2 cm or bigger, which is amendable for (super-)selective TATE as the target lesion.
  • 5. ECOG score 2 or less
  • 6. Child-Pugh scores 5-7 for HCC patients
  • 7. All prior chemotherapy at least 4 weeks prior to study treatment. Immunotherapy not subject to this limitation.
  • 8. No major GI bleeding in the prior 2 months.
  • 8. Hgb\>=8, platelet \>= 50,000, Cr =\< 2, AST and ALT \< 10 X ULN, t-Bilirubin \< 3, 9. Patients with a history of major autoimmune disorders excluded.
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 16 August 2017
  • First Submitted that Met QC Criteria 22 August 2017
  • First Posted 24 August 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 September 2023
  • Last Update Posted 21 September 2023
  • Last Verified September 2023