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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

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

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC (NCT04701476) is a Phase 2 interventional studying Colorectal Cancer; Lung Cancer, sponsored by Teclison Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Colorectal Cancer; Lung Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 110 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Colorectal Cancer; Lung Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - your organs (liver, kidneys, etc.) are working well enough based on blood tests Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

TATE and pembrolizumab

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.

DRUG

TAS-102 pill

The comparator of the mCRC arm is TAS-102 at 60 mg BID 5 days per week for 2 weeks then 2 weeks off.

DRUG

Regorafenib Pill

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.

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04701476), the sponsor (Teclison Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04701476 clinical trial studying?

Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04701476?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04701476?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04701476. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04701476. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.