Study on TATE and Pembrolizumab for Metastatic Colorectal and Non-Small Cell Lung Cancer

Sponsor: Teclison Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04701476

Provider View

This clinical trial is testing a new treatment combination for patients with metastatic colorectal cancer or non-small cell lung cancer that has spread to the liver. The study involves using a procedure called Trans-arterial Tirapazamine Embolization (TATE) along with the drug Pembrolizumab.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of a new treatment combination for patients with metastatic colorectal cancer (mCRC) and non-small cell lung cancer (NSCLC) that has spread to the liver. The treatment involves a procedure called Trans-arterial Tirapazamine Embolization (TATE) combined with the drug Pembrolizumab. For colorectal cancer patients, the study will compare this new treatment to standard care options to see which is more effective in improving survival. For lung cancer patients, the study will focus on how well the treatment works in shrinking tumors.

Description

This study is open to patients with metastatic colorectal cancer (mCRC) and non-small cell lung cancer (NSCLC) that has spread to the liver. It aims to test a new treatment combination involving Trans-arterial Tirapazamine Embolization (TATE) and Pembrolizumab.

For patients with colorectal cancer, the study will randomly assign participants to receive either the new treatment or standard FDA-approved treatments like TAS-102 or regorafenib. The main goal is to compare the overall survival rates between the two groups.

For patients with lung cancer, all participants will receive the new treatment, and the study will measure how well the tumors respond to the therapy.

The study is designed to find out if this new combination can offer better outcomes for patients whose cancer has not responded to previous treatments.

Eligibility Criteria

Inclusion Criteria

  • Have liver metastases from colorectal cancer (mCRC) or non-small cell lung cancer (NSCLC) without specific genetic mutations (EGFR or AKT).
  • For colorectal cancer: the disease must have progressed after at least two standard chemotherapy treatments.
  • For lung cancer: the disease must have progressed after chemotherapy and an immune checkpoint inhibitor.
  • Have measurable tumors that can be tracked.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have completed any previous chemotherapy at least four weeks ago and have recovered from any side effects.
  • Have adequate organ function as determined by specific medical tests.

Exclusion Criteria

  • Have had an organ transplant.
  • Have more than 50% of the liver affected by cancer.
  • Have low oxygen levels in the blood (less than 92% on room air).
  • Have a history of autoimmune disorders.
  • Have cancer that has spread to the central nervous system (CNS).
  • Have had major gastrointestinal bleeding in the past two months.

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