Recruiting
Phase 2

TATE & Pembrolizumab

Sponsor:

Teclison Ltd.

Code:

NCT04701476

Conditions

Colorectal Cancer; Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TATE and pembrolizumab

TAS-102 pill

Regorafenib Pill

Study Details

Brief summary:

Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab.

Conditions

Colorectal Cancer; Lung Cancer

Study ID

NCT04701476

Start date

May 20, 2021

Status verified date

Apr, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: colorectal cancer

metastatic colorectal cancer progressed on at least two lines of chemotherapy

experimental: NSCLC

Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy

Interventions

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.

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.

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.

Primary outcome measure

  • Overall Survival for the mCRC cohort [ Time Frame: 24 months ]
  • Overall Response Rate (ORR) for the NSCLC cohort [ Time Frame: within 24 months ]

Central Contacts and Locations

Central contacts

Ray Lee, MD. PhD.

8043341076ray.lee01@teclison.com

Chiwei Lu

chiwei.lu4@teclison.com

Locations

University of California, Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Contacts

Miranda Duron

mnduron@hs.uci.edu

More Information

Sponsor

Teclison Ltd.

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • colorectal cancer
  • NSCLC
  • pembrolizumab
  • tirapazamine
  • Liver metastasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Teclison Ltd. on 2026-04-16.