NCT04701476

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
17mo left

Started May 2021

Longer than P75 for phase_2

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
May 2021Sep 2027

First Submitted

Initial submission to the registry

January 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

5.9 years

First QC Date

January 6, 2021

Last Update Submit

April 15, 2026

Conditions

Colorectal Cancer; Lung Cancer

Keywords

colorectal cancerNSCLCpembrolizumabtirapazamineLiver metastasis

Outcome Measures

Primary Outcomes (2)

  • Overall Survival for the mCRC cohort

    From the first day of treatment to death

    24 months

  • Overall Response Rate (ORR) for the NSCLC cohort

    Per RECIST 1.1 criteria

    within 24 months

Secondary Outcomes (4)

  • Duration of Response

    24 months

  • Response rate

    24 months

  • PFS

    24 months

  • TTP

    24 months

Study Arms (2)

colorectal cancer

EXPERIMENTAL

metastatic colorectal cancer progressed on at least two lines of chemotherapy

Drug: TATE and pembrolizumabDrug: TAS-102 pillDrug: Regorafenib Pill

NSCLC

EXPERIMENTAL

Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy

Drug: TATE and pembrolizumab

Interventions

Regorafenib PillDRUG

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.

Also known as: STIVARGA
colorectal cancer
TATE and pembrolizumabDRUG

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.

Also known as: TATE: Trans-arterial Tirapazamine Embolization;
NSCLCcolorectal cancer
TAS-102 pillDRUG

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

Also known as: LONSURF
colorectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You 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 may not qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

China Medical University Hsinchu Hospital

Hsinchu, Taiwan

RECRUITING

Chung Shan Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsLung Neoplasms

Interventions

pembrolizumabtrifluridine tipiracil drug combinationregorafenib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ray Lee

    Teclison Limited

    STUDY DIRECTOR

Central Study Contacts

Ray Lee, MD. PhD.

CONTACT

8043341076ray.lee01@teclison.com

Chiwei Lu

CONTACT

chiwei.lu4@teclison.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open-label study in two indications. The mCRC cohort will be a randomized trial for TATE+Pembrolizumab versus standard 3rd line therapy for mCRC. The NSCLC cohort will be single-arm study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 8, 2021

Study Start

May 20, 2021

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

International meeting report or medical Journal publication

Locations

TW(2)US(1)