Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
All liver metastatic lesions will be treated with TATE for maximally debulking. Pembrolizumab IV infusion per standard schedule every 3 or 6 weeks until progression or maximally 2 years.
The comparator of the mCRC arm is TAS-102 at 60 mg BID 5 days per week for 2 weeks then 2 weeks off.
As an alternative to TAS-102 per treating physician's discretion. If selected, Regorafenib 160 mg oral daily for 3 weeks on and one week off, every 4 weeks per cycle. Do not take Regoarefnib if taking TAS-102.
University of California, Irvine Medical Center
Orange, California, United States
RECRUITINGChina Medical University Hsinchu Hospital
Hsinchu, Taiwan
RECRUITINGChung Shan Medical University Hospital
Taichung, Taiwan
RECRUITINGOverall Survival for the mCRC cohort
From the first day of treatment to death
Time frame: 24 months
Overall Response Rate (ORR) for the NSCLC cohort
Per RECIST 1.1 criteria
Time frame: within 24 months
Duration of Response
per RECIST 1.1
Time frame: 24 months
Response rate
in TATE treated or TATE-untreated lesions by RECIST and mRECIST
Time frame: 24 months
PFS
Progression Free Survival
Time frame: 24 months
TTP
Time to Progression
Time frame: 24 months
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