Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Patients who have been histopathologically diagnosed with colorectal adenocarcinoma
Patients who have undergone radical curative resection of the primary and metastatic tumors
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
Patients who tested positive for ctDNA using SignateraTM by an analysis of the latest blood samples collected within 3 months prior to enrollment
Patients with no obvious relapse confirmed by chest, abdominal, and pelvic CT scans, etc.
Patients who are capable of oral ingestion
Patients aged 20 years or older at the time of informed consent
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

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
Patients with no diarrhea or stomatitis of Grade 2 or severer according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Patients who voluntarily gave written consent to participate in the trial after receiving a thorough explanation of the trial before enrolling in the trial

Exclusion Criteria:

Patients with a history of treatment with FTD/TPI
Patients with a history of treatment with 2 or more regimens of postoperative adjuvant chemotherapy (Preoperative chemotherapy will not be counted as a regimen.)
Patients with a past history of a malignant tumor
Patients with a local or systemic active infection requiring intervention
Patients who are positive for HBs antigen or positive for HCV antibody
Patients who are positive for HIV antibody (Patients who have not been tested for HIV antibody may be enrolled.)
Patients with poorly controlled infections or diabetes
Patients with a past history of interstitial lung diseases (such as interstitial pneumonia and pulmonary fibrosis) requiring treatment or extensive findings of these diseases on CT
Patients with a serious complication
Patients who have been receiving systemic administration (oral or intravenous) of steroids (for 2 weeks or more at a dose of the equivalent of ≥ 10 mg/day of prednisolone)
Patients for whom enrollment in the trial is difficult because of clinically problematic psychiatric disorders
Pregnant or lactating women
Patients with reproductive potential who do not wish to use adequate contraceptive measures during the period of participation in the trial and during the contraception period
Patients who are judged by the attending physician to be ineligible for enrollment in the trial for other reasons