Combining TATE and Pembrolizumab for advanced colorectal and lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label study aims to treat patients with refractory metastatic colorectal cancer (mCRC) and non-small cell lung cancer (NSCLC) with liver metastasis using Trans-arterial Tirapazamine Embolization (TATE) in combination with Pembrolizumab. Patients with mCRC will be randomized to receive either the combination treatment or standard care options, while all NSCLC patients will receive the combination treatment. The primary endpoints are Overall Survival (OS) for mCRC patients and Overall Response Rate (ORR) for NSCLC patients, allowing for a comparative analysis of treatment efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• University of California, Irvine Medical Center
  Orange, California, United States Recruiting
• China Medical University Hsinchu Hospital
  Hsinchu, Taiwan Recruiting
• Chung Shan Medical University Hospital
  Taichung, Taiwan Recruiting

Study contacts

• Study coordinator: Ray Lee, MD. PhD.
• Email: ray.lee01@teclison.com
• Phone: 8043341076

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.