Actively Recruiting
TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
Led by M.D. Anderson Cancer Center · Updated on 2026-03-06
25
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
T
Taiho
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological confirmation of colorectal cancer
- Completed post-R0 resection of stages II, III, or IV colorectal cancer and all planned curative therapies including at least 3 months of oxaliplatin chemotherapy
- No definitive radiographic evidence of disease within 28 days before or after a positive ctDNA assay
- Positive ctDNA assay indicating minimal residual disease confirmed by Signatera assay or equivalent
- Adequate organ and marrow function: neutrophils 1,000/mcL, platelets 100,000/mcL, total bilirubin institutional upper limit of normal, AST/ALT 3 times institutional upper limit of normal, creatinine 1.5 times ULN or creatinine clearance 60 mL/min
- ECOG performance status 0 or 1
- Age 18 years or older
- Ability to understand and willingness to sign informed consent
- Willingness to use effective contraception during study and for 7 months after last dose
You will not qualify if you...
- Presence of other active invasive malignancies that could interfere with ctDNA analysis (except known clonal hematopoiesis)
- Clinically significant abnormal serum electrolytes (potassium, calcium, magnesium) per investigator judgment
- Severe autoimmune or cardiovascular disorders interfering with study participation
- Persistent adverse events grade 2 or higher except alopecia and neuropathy
- Any condition that may prohibit investigational treatment use, affect study results, or cause undue risk
- Known hypersensitivity or risk of allergic/anaphylactic reactions to trial drugs
- Pregnancy or breastfeeding
- Inability to take oral medication or conditions affecting drug absorption
- Receiving other investigational agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Alisha Bent, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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