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 study to treat patients with refractory metastatic colorectal cancer and non-small cell lung cancer with liver metastasis. Patients enrolled in the mCRC cohort will be randomized to receive study treatment Trans-arterial Tirapazamine Embolization (TATE)+Pembrolizumab or FDA-approved standard of care, such as TAS-102 or regorafenib, and their Overall Survival (OS) will be compared in the two cohorts as the primary endpoint. Patients enrolled in the NSCLC cohort will all receive study treatment TATE+Pembrolizaumb and Overall Response Rate (ORR) will be the primary endpoint.

Keywords

Colorectal Cancer; Lung Cancer colorectal cancer NSCLC pembrolizumab tirapazamine Liver metastasis Lung Neoplasms Colorectal Neoplasms TATE and pembrolizumab TAS-102 pill Regorafenib Pill

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
  • At least 4 weeks from prior chemotherapy and free from chemo-related toxicity
  • 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 research study
Study Type
Interventional
Participants
Expecting 110 study participants
Last Updated