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:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT07085169
Eligibility Criteria:
Inclusion Criteria:
1. age over 60 years old, male and female
2. histologically confirmed adenocarcinoma of the colon or rectum
3. patients with metastatic or advanced unresectable diseases who had received two or more previous chemotherapy regimens or intolerance to last regimen
4. with or without measurable lesions
5. ECOG 0 to 2, expected survival time over 3 months
6. Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
7. Signed informed consent and willing to follow the study protocol
Exclusion Criteria:
1. symptomatic metastases of central nervous system
2. other primary malignancies
3. uncontrollable comorbidities, such as hypertension, thrombotic diseases, chronic kidney disease
4. organ functions that cannot tolerate study treatment
5. bowel obstruction or other conditions affecting oral administration
6. allergic to study medication
7. other conditions that patients are unsuitable for this study assessed by the investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT07085169
Study Brief:
Protocol Section:
NCT07085169