TAS-102 for Colorectal Cancer

Overseen By Arvind Dasari, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Other malignancies, Electrolyte imbalance, Severe disorders, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called TAS-102 (also known as Trifluridine/tipiracil hydrochloride mixture or Lonsurf) for individuals with colorectal cancer. The researchers aim to assess how this treatment affects circulating tumor DNA levels (genetic material from cancer cells in the blood) after six months. Participants should have undergone colorectal cancer surgery and completed chemotherapy but still have a specific type of residual disease detected in their blood. This trial may suit those who have finished their main cancer treatments, show no clear signs of cancer on scans, but have a positive tumor DNA test. As a Phase 2 trial, it focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial investigators to get a clear answer.

Is there any evidence suggesting that TAS-102 is likely to be safe for humans?

Research has shown that TAS-102 is generally well-tolerated by patients with colorectal cancer. A combined safety review found that this treatment maintains a consistent safety record. In studies involving patients with various cancer types, including colorectal cancer, TAS-102 demonstrated manageable side effects.

Some patients experienced side effects, mostly mild to moderate. Common side effects included low blood cell counts, tiredness, and nausea. While not everyone will encounter these side effects, they remain possible.

Additionally, the FDA has approved TAS-102 for treating colorectal cancer, confirming its prior safety testing in humans. This approval indicates a certain level of confidence in its safety, although individual experiences can vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

TAS-102 is unique because it combines trifluridine and tipiracil, which work together to interfere with cancer cell growth. Unlike other treatments for colorectal cancer that mainly target specific pathways or proteins, TAS-102 introduces a new mechanism by incorporating trifluridine, which gets directly into the DNA of cancer cells to disrupt their function. Researchers are excited about this treatment because it offers a fresh approach, potentially providing benefits for patients whose cancer has become resistant to standard therapies like chemotherapy.

What evidence suggests that TAS-102 might be an effective treatment for colorectal cancer?

Research has shown that TAS-102, which participants in this trial will receive, effectively treats advanced colorectal cancer. Studies indicate that it helps patients live longer and slows cancer progression compared to those not taking it. One analysis found that TAS-102 improved both overall survival (how long patients live) and progression-free survival (how long the cancer does not worsen). Furthermore, when combined with another drug called bevacizumab, TAS-102 led to even longer survival times than when used alone. Real-world evidence supports these findings, confirming its benefits for patients with advanced colorectal cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Alisha Bent, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults over 18 with colorectal cancer who've had surgery and finished adjuvant therapy can join. They must have no visible cancer but a positive ctDNA test for minimal residual disease, good organ function, and an ECOG performance status of 0 or 1. Pregnant women, those with severe health issues, allergies to trial drugs, or conditions affecting drug absorption cannot participate.

Inclusion Criteria

Is willing to utilize contraception. Female subjects agree to use highly effective contraception combined with an additional barrier method (eg, diaphragm, with a spermicide) while on study and for 7 months after the last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for 7 months after the last treatment

Is able to understand and is willing to sign a written informed consent document

I had surgery to remove colorectal cancer and finished all follow-up treatments.

Exclusion Criteria

Has known hypersensitivity to the trial drugs or their excipients or is at risk of allergic of anaphylactic reaction to drug product according to the Investigator's judgment

I have a lasting side effect from treatment that is moderate or worse, except for hair loss or nerve issues.

Is receiving any other investigational agent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TAS-102 therapy for 6 months

6 months

Follow-up

Participants are monitored for ctDNA clearance and survival outcomes after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• TAS-102

Trial Overview The trial is testing TAS-102's effectiveness in patients with colorectal cancer who show no signs of the disease after treatment but have a positive ctDNA test indicating minimal residual disease. The study monitors ctDNA levels after six months on TAS-102.

How Is the Trial Designed?

Group I: TAS-102 Experimental Treatment 1 Intervention

TAS-102 should be taken by mouth 2 times a day, within 1 hour after your morning and evening meals (about 12 hours apart).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Taiho

Collaborator

Trials

1

Recruited

30+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37414979/

Efficacy and safety of trifluridine/tipiracil (TAS-102) in ... In this meta-analysis, TAS-102 treatment resulted in longer OS, PFS, TTF, and higher DCR in patients with mCRC versus placebo and/or BSC. TAS- ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3580

Real-world treatment patterns and outcomes with ... Real-world effectiveness and safety of trifluridine/tipiracil plus bevacizumab in metastatic colorectal cancer: A retrospective observational ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2214963

Trifluridine–Tipiracil and Bevacizumab in Refractory ... Among patients with refractory metastatic colorectal cancer, treatment with FTD–TPI plus bevacizumab resulted in longer overall survival than FTD–TPI alone.

4. taihooncology.com taihooncology.com/us/news/taiho-oncology-presents-real-world-findings-for-lonsurf-at-the-asco-gastrointestinal-cancers-symposium/

Taiho Oncology Presents Real-World Findings for ... Real-world studies confirm that pairing LONSURF with bevacizumab increases efficacy in patients with metastatic colorectal cancer ...

5. foxchase.org foxchase.org/news/fox-chase-cancer-center-researcher-shows-biweekly-dose-tas-102-reduces-toxicity-and-remains

Fox Chase Cancer Center Researcher Shows Biweekly ... Fox Chase Cancer Center Researcher Shows Biweekly Dose of TAS-102 Reduces Toxicity and Remains Effective for Treatment of Colorectal Cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11067808/

Efficacy and Safety of Trifluridine/Tipiracil-Containing ... A systematic review of observational studies of trifluridine/tipiracil (TAS-102) for metastatic colorectal cancer. Acta Oncol. 2019;58(8): ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e15583

Real-world data on efficacy and safety of trifluridine-tipiracil ... The combination of trifluridine/tipiracil with bevacizumab (TAS-Bev) is presented as a promising alternative, showing efficacy data in its phase 3 SUNLIGHT ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2059702922002678

Pooled safety analysis from phase III studies of trifluridine ... These results support FTD/TPI as a well-tolerated treatment in patients with mGC/GEJC or mCRC, with a consistent safety profile.

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2015/207981Orig1s000MedR.pdf

207981Orig1s000 | FDA 761 CRC patients receiving this dosage of TAS-102 (called “Safety Data Group 1”) confirmed the safety profile observed for Safety Data Group 2.