Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT05266820
Eligibility Criteria:
1. Have histological or cytological documentation of adenocarcinoma of the colon or rectum (mCRC).
2. For patients with disease progression after conventional treatment, TAS-102 is determined as the third-line therapy or beyond according to the routine treatment practice of the researcher.
3. Aged no less than 20 years.
5.Have a measurable disease, according to RECIST version 1.1 6.Eastern Cooperative Oncology Group performance status 0-2. 7.Life expectancy of at least 12 weeks. 8.For women with reproductive potential, serum tests were performed within 7 days before the start of study treatment β- Human chorionic gonadotropin (β- HCG) pregnancy test, the result is negative. Women with reproductive potential must agree to take appropriate contraceptive measures with informed consent until at least 6 months after the last use of the study drug.
9.Sufficient bone marrow, liver and kidney functions and meet the following laboratory requirements:
1. Platelet count ≥75 × 109 /L
2. Hemoglobin level ≥90 g/L
3. Absolute neutrophil count ≥1.5× 109 /L
a) Total bilirubin ≤1.5 × upper limit of normal (ULN) b) Alanine aminotransferase and aspartate aminotransferase ≤2.5 × ULN (≤5 × ULN for patients with liver metastases) d) Serum creatinine ≤1.5 × ULN e) Glomerular filtration rate ≥30 ml/min/1.73 m2, according to the modified diet in renal disease abbreviated formula 10.Able to take oral drugs. 11.Have signed written informed consent.
Exclusion criteria
1. With arterial or venous thrombosis or embolic events such as myocardial infarction, cerebral thrombosis, intracerebral hemorrhage, deep venous thrombosis or pulmonary embolism within 6 months before the start of the study.
2. Evidence or history of any bleeding diathesis, irrespective of severity. Any hemorrhage or bleeding event ≥ grade 3 (adverse events per CTCAE v5.0) within 4 weeks prior to the start of treatment.
3. Peripheral neuropathy \> grade 1 (adverse events per CTCAE v5.0).
4. History of uncontrolled or medicated heart disease.
5. Seizure disorder requiring medication.
6. Known history of human immunodeficiency virus (HIV) infection.
7. Patients with an active infection.
8. Other uncontrolled concurrent diseases determined by the researchers as not meeting the study conditions.
9. Patients with ascites and pleural effusion with clinical symptoms requiring treatment.
10. Known allergy to any of the study drug ingredients.
11. Unable to swallow oral medication.
12. Prior exposure to TAS-102 or thalidomide.
13. Patients who have brain metastases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05266820
Study Brief:
Protocol Section:
NCT05266820