What this study is
Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab.
What's being tested
- TATE and pembrolizumab
Intervention · DRUG
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.
- TAS-102 pill
Intervention · DRUG
The comparator of the mCRC arm is TAS-102 at 60 mg BID 5 days per week for 2 weeks then 2 weeks off.
- Regorafenib Pill
Intervention · DRUG
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.
Study details
- 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
- Sponsor
- Teclison Ltd.
- Conditions
- Colorectal Cancer; Lung Cancer
- Enrolling
- 110 people
- Starts
- 2021-05-20
- Est. completion
- 2025-12-31
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openContact for 2 of 3 open sites
- sandy Lai · Contactsandy6618@teclison.com
University of California, Irvine Medical Center
Orange, California, United States
- Miranda Duron · Contactmnduron@hs.uci.edu
Recruiting
2 sites outside the US
China Medical University Hsinchu Hospital
Hsinchu, Taiwan
RecruitingChung Shan Medical University Hospital
Taichung, Taiwan
Recruiting
Study team
Sponsor
Teclison Ltd.
Study ID LT-007
Study director
Ray Lee
Teclison Limited
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.