Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection

Inclusion Criteria

• •1. Patients who have been histopathologically diagnosed with colorectal adenocarcinoma
• •2. Patients who have undergone radical curative resection of the primary and metastatic tumors
• •3. Patients with colon or rectal cancer of Stage III based on final findings (T any N1/2 M0) (UICC TNM Classification, 8th Edition) who have a past history of standard postoperative chemotherapy
• •4. Patients who tested positive for ctDNA using SignateraTM by an analysis of the latest blood samples collected within 3 months prior to enrollment
• •5. Patients with no obvious relapse confirmed by chest, abdominal, and pelvic CT scans, etc.
• •6. Patients who are capable of oral ingestion
• •7. Patients aged 20 years or older at the time of informed consent
• •8. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• •9. Patients who have no severe disorder in major organs (such as the bone marrow, heart, lungs, liver, and kidneys) and meet the following criteria (Data obtained most recently and within 14 days of the date of enrollment will be used for enrollment. Data obtained 2 weeks before the date of enrollment, on the same day of the week as the enrollment date, may be used for enrollment.)
• •* Neutrophil count ≥ 1,500/mm3
• •* Platelet count ≥ 100,000/mm3
• •* Hemoglobin ≥ 8.0 g/dL
• •* Serum creatinine ≤ 1.5 mg/dL
• •* Total bilirubin ≤ 1.5 mg/dL
• •* ALT and AST ≤ 100 U/L
• •10. Patients with no diarrhea or stomatitis of Grade 2 or severer according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
• •11. Patients who voluntarily gave written consent to participate in the trial after receiving a thorough explanation of the trial before enrolling in the trial