Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab.

Official Title

An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung Cancer With a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and Pembrolizumab

Details

This study is an open-label single-arm study to treat patients with refractory metastatic colorectal cancer and non-small cell lung cancer with liver metastasis. Patients' metastatic liver lesions will be treated with Trans-arterial Tirapazamine Embolization (TATE) for maximal tumor debulking along with IV injection of Pembrolizumab every three weeks until disease progression or maximally two years.

Keywords

Colorectal Cancer; Lung Cancer colorectal cancer NSCLC pembrolizumab tirapazamine Lung Neoplasms Colorectal Neoplasms TATE and pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Liver metastatic MSS-mCRC or NSCLC without EGFR or AKT mutations
  • mCRC progressed on at least two lines of standard chemotherapy; or
  • NSCLC progressed on chemotherapy and an immune checkpoint inhibitor
  • Measurable disease
  • ECOG 0-1
  • Adequate organ function

You CAN'T join if...

  • Prior organ transplantation
  • Liver metastasis more than 50%
  • Oxygen saturation less than 92% in room air
  • Prior autoimmune disorder
  • CNS metastasis
  • Major GI bleeding in the last 2 months

Locations

  • UC Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • China Medical University Hsinchu Hospital accepting new patients
    Hsinchu Taiwan
  • Chung Shan Medical University Hospital accepting new patients
    Taichung Taiwan

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Teclison Ltd.
ID
NCT04701476
Phase
Phase 2
Study Type
Interventional
Last Updated