TAS-102 + Radiation for Colorectal Cancer

Overseen By Tarin Grillo

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Massachusetts General Hospital

Must not be taking: Investigational agents, Anti-cancer therapy

Disqualifiers: Pregnancy, Ascites, Encephalopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

56 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying a drug in combination with radiation therapy as a possible treatment for hepatic metastases from colorectal cancer. The interventions involved in this study are: * Trifluridine (TAS-102) * Radiation Therapy

Research Team

Theodore S. Hong, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults with colorectal cancer that has spread to the liver (1-4 metastases) and is inoperable due to location, fitness, or additional disease outside the liver. Participants should have stable extrahepatic disease for 3 months, measurable disease by CT scan, no prior liver radiation but may have had other treatments if more than 3 weeks ago. They must be physically able to take oral medication and not pregnant or breastfeeding.

Inclusion Criteria

Liver metastases may be diagnosed by imaging alone, no liver biopsy is required

My cancer outside the liver is stable, and I'm referred for liver-focused radiation.

Expected survival must be greater than three months

Exclusion Criteria

I am not pregnant or breastfeeding.

I have severe abdominal swelling or brain function issues.

I have health issues that could make radiation treatment harder for me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Trifluridine (TAS-102) in combination with radiation therapy. TAS-102 dosing occurs on days 1 through 5 and 8 through 12, with radiation therapy administered concurrently.

2 weeks

Daily visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of ctDNA levels and local control.

4 weeks

1 visit (in-person) at 1 month post-treatment

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival, with assessments every 6 months for two years or until death.

2 years

Treatment Details

Interventions

• Photon SBRT
• TAS-102

Trial Overview The trial is testing a combination of TAS-102 (Trifluridine), an oral chemotherapy drug, with Photon SBRT (a type of precise radiation therapy). The goal is to assess how well this combo works for treating liver metastases from colorectal cancer compared to current standard treatments.

Participant Groups

Group I: TAS-102 Experimental Treatment 2 Interventions

* Photon treatments will be performed on a linear accelerator * Photon SBRT will be given during TAS-102 dosing * TAS-102 dosing occurs on days 1 through 5 and 8 through 12 * TAS-102 tablets should be taken twice a day orally

TAS-102 is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Lonsurf for:

• Metastatic colorectal cancer

Approved in European Union as Lonsurf for:

• Metastatic colorectal cancer

Approved in Japan as Lonsurf for:

• Metastatic colorectal cancer

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Taiho Oncology, Inc.

Industry Sponsor

Trials

79

Recruited

12,700+

Tim Whitten

Taiho Oncology, Inc.

Chief Executive Officer since 2018

MBA and Pharmacy degree

Harold Keer

Taiho Oncology, Inc.

Chief Medical Officer

MD, PhD