Colorectal CancerPhase 2NCT05343013
TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
A Phase 2 study testing TAS-102 in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To measure the level of circulating tumor DNA (ctDNA) in the blood of colorectal cancer patients after 6 months of receiving TAS-102 therapy. ctDNA is genetic material from tumor cells that can be found and measured in the blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- TAS-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 15 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has histological confirmation of colorectal cancer
- Received post-R0 resection of stages II, III, or IV colorectal cancer and has completed all planned curative intent therapies that must include ≥ 3 months of oxaliplatin containing chemotherapy
- Has no definitive evidence of radiographic disease per assessment by investigators within 28 days (before or after) a positive ctDNA assay
- Has minimal residual disease as defined by positive ctDNA assay (completed as standard-of-care at MD Anderson). Patients may be identified for enrollment with any Clinical Laboratory Improvement Amendments (CLIA)-certified ctDNA assay for MRD. MRD status will be confirmed with the Signatera assay prior to initiation of therapy (unless the prior testing was also done with Signatera in which case this test would not require confirmation)
- Has adequate organ and marrow function as defined below:
- absolute neutrophil count: ≥1,000/mcL
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- platelets: ≥100,000/mcL
- total bilirubin: ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT): ≤3 × institutional ULN
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥60 mL/min. Creatinine clearance (Clcr) can either be measured in a 24-hour urine collection or estimated by the Cockcroft-Gault equation as follows: Clcr (mL/min) = [(140 - age) x (weight in kg) ÷ [72 x (serum creatinine in mg/dL)] [0.85 if female]
- Has ECOG performance status (PS) of 0 or 1
- Is of age ≥ 18 years. Because no dosing or adverse-event data are currently available on the use of TAS-102 in patients, children <18 years of age are excluded from this study.
- Is able to understand and is willing to sign a written informed consent document.
- 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 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.
Who cannot join
- Has other concomitant active, invasive malignancies that may interfere with ctDNA analysis (known clonal hematopoesis of unknown potential allowed)
- Has serum electrolytes, potassium, calcium, or magnesium levels outside of the normal laboratory reference range which are clinically significant in the investigator's judgment
- Has significant concomitant health conditions including but not limited to severe autoimmune or cardiovascular disorders that may interfere with participation in the study per assessment by investigators
- Has a persistent adverse event, except alopecia and neuropathy, greater than or equal to grade 2 of the Common Toxicity Criteria for Adverse Events (CTCAE) v. 5.0
- Has another disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect may (a) prohibit use of the investigational product, (b) affect interpretation of study results, or (c) put the patient at undue risk of harm
- 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 judgement
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- Is pregnant or lactating
- Is unable to take medication orally or has any other condition that investigators believe may affect absorption of the investigational product
- Is receiving any other investigational agent.
Trial locations and contacts
1 site in 1 country.
About this study
To measure the level of circulating tumor DNA (ctDNA) in the blood of colorectal cancer patients after 6 months of receiving TAS-102 therapy. ctDNA is genetic material from tumor cells that can be found and measured in the blood.
Read the detailed description
Primary Objectives:
The primary objective is to determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.
Secondary Objectives:
- To determine the 3-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease.
- To determine the disease free survival (DFS) amongst colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.
- To determine the overall survival (OS) amongst colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.
- To determine the safety and tolerability of TAS-102 for the treatment of colorectal cancer patients with minimal residual disease.
Exploratory Objectives:
- To determine markers of response and resistance in archival tumor tissue including but not limited to immune profiles of tumor-infiltrating lymphocytes, expression of immune markers in tumor cells and microenvironment, and molecular markers (including but not limited to mutations, deletions, and/or amplifications or cancer molecular subtype)
- To determine changes in profiles of circulating lymphocytes and ctDNA with treatment
- To determine baseline characteristics in archival tumor and/or plasma that may predict clinical benefit
- Conditions
- Colorectal Cancer
- Being tested
- TAS-102
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-102Drug
Also called trifluridine, tipiracil, Lonsurf
GIven by PO
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 | Experimental | TAS-102 should be taken by mouth 2 times a day, within 1 hour after your morning and evening meals (about 12 hours apart). Receives: Drug: TAS-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start6 Jun 2022
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Taiho
- Responsible party
- Sponsor
- Investigators
- Alisha Bent, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343013
- Sponsor's protocol ID
- 2021-0823
- Other IDs
- NCI-2022-03438
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Pellatt AJ, Bent A, Hornstein N, Parseghian C, Huey R, Raghav K, Morris V, Overman M, Morelli P, Willis J, Le P, Shen JP, Kee B, Eluri M, Higbie V, Alfaro-Munoz K, Aziz K, Kell R, Sun R, Kopetz S, Dasari A. Phase II Trial of TAS-102 in Colorectal Cancer Patients With Circulating Tumor DNA-Defined Minimal Residual Disease After Adjuvant Therapy: INTERCEPT-TT. JCO Precis Oncol. 2025 Jul;9:e2500142. doi: 10.1200/PO-25-00142. Epub 2025 Jul 16.
PubMed 40669021
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT05343013
- Acronym / sponsor ID
- 2021-0823
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Taiho
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To measure the level of circulating tumor DNA (ctDNA) in the blood of colorectal cancer patients after 6 months of receiving TAS-102 therapy. ctDNA is genetic material from tumor cells that can be found and measured in the blood.
Detailed description
Primary Objectives:
The primary objective is to determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.
Secondary Objectives:
- To determine the 3-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease.
- To determine the disease free survival (DFS) amongst colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.
- To determine the overall survival (OS) amongst colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.
- To determine the safety and tolerability of TAS-102 for the treatment of colorectal cancer patients with minimal residual disease.
Exploratory Objectives:
- To determine markers of response and resistance in archival tumor tissue including but not limited to immune profiles of tumor-infiltrating lymphocytes, expression of immune markers in tumor cells and microenvironment, and molecular markers (including but not limited to mutations, deletions, and/or amplifications or cancer molecular subtype)
- To determine changes in profiles of circulating lymphocytes and ctDNA with treatment
- To determine baseline characteristics in archival tumor and/or plasma that may predict clinical benefit
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS-102 | Experimental | Drug: TAS-102TAS-102 should be taken by mouth 2 times a day, within 1 hour after your morning and evening meals (about 12 hours apart). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Has histological confirmation of colorectal cancer
- Received post-R0 resection of stages II, III, or IV colorectal cancer and has completed all planned curative intent therapies that must include ≥ 3 months of oxaliplatin containing chemotherapy
- Has no definitive evidence of radiographic disease per assessment by investigators within 28 days (before or after) a positive ctDNA assay
- Has minimal residual disease as defined by positive ctDNA assay (completed as standard-of-care at MD Anderson). Patients may be identified for enrollment with any Clinical Laboratory Improvement Amendments (CLIA)-certified ctDNA assay for MRD. MRD status will be confirmed with the Signatera assay prior to initiation of therapy (unless the prior testing was also done with Signatera in which case this test would not require confirmation)
- Has adequate organ and marrow function as defined below:
Key exclusion criteria (9 listed)
- Has other concomitant active, invasive malignancies that may interfere with ctDNA analysis (known clonal hematopoesis of unknown potential allowed)
- Has serum electrolytes, potassium, calcium, or magnesium levels outside of the normal laboratory reference range which are clinically significant in the investigator's judgment
- Has significant concomitant health conditions including but not limited to severe autoimmune or cardiovascular disorders that may interfere with participation in the study per assessment by investigators
- Has a persistent adverse event, except alopecia and neuropathy, greater than or equal to grade 2 of the Common Toxicity Criteria for Adverse Events (CTCAE) v. 5.0
- Has another disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect may (a) prohibit use of the investigational product, (b) affect interpretation of study results, or (c) put the patient at undue risk of harm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS-102Also: trifluridine, tipiracil, LonsurfGIven by PO | Drug | TAS-102 |
Primary outcome
To determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Derived from this study: PubMed 40669021Pellatt AJ, Bent A, Hornstein N, Parseghian C, Huey R, Raghav K, Morris V, Overman M, Morelli P, Willis J, Le P, Shen JP, Kee B, Eluri M, Higbie V, Alfaro-Munoz K, Aziz K, Kell R, Sun R, Kopetz S, Dasari A. Phase II Trial of TAS-102 in Colorectal Cancer Patients With Circulating Tumor DNA-Defined Minimal Residual Disease After Adjuvant Therapy: INTERCEPT-TT. JCO Precis Oncol. 2025 Jul;9:e2500142. doi: 10.1200/PO-25-00142. Epub 2025 Jul 16.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alisha Bent, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAS-102 in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy. (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05343013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.