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 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 12:30 AM
NCT ID:
NCT06104267
Eligibility Criteria:
Inclusion Criteria:
1. Histological or cytological documentation of adenocarcinoma of the colon or rectum.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
3. Life expectancy of at least 6 months.
4. Adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol（ALT/AST≤2.5×UNL or ≤5×UNL with liver metastasis,TBIL≤2.5×UNL,Cr≤1.5×UNL,WBC≥3×109/L,NE≥1.5×109/L，PLT≥80×109/L，Hb≥90g/L,PT-INR/APTT \<1.5UNL; LVEF≥ 50%）.
5. Subjects must complete the treatment and follow-up on schedule according to the research plan.
Exclusion Criteria:
1. Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\].
2. Any serious or unstable medical condition、mental illness or known active alcohol or drug abuse or dependence.
3. Unhealed surgical wounds and intolerance
4. Extreme fatigue, anemia (\<80 g/L) or dystaxia
5. toxicity grade ≥III in chemoradiotherapy or targeted therapy (NCI-CTCAE 5.0), or severe intolerance
6. exercise contraindications for patients with cardiovascular diseases or pulmonary diseases (referring to the Chinese Guideline for Cardiac Rehabilitation and Secondary Prevention \[edition 2018\] and Evidence-based Practice Guidelines for Clinical Rehabilitation of Chronic obstructive Pulmonary Disease \[edition 2021\]); uncontrolled unstable angina, diastolic dysfunction grade IV, uncontrolled severe arrhythmia, uncontrolled hypertension;
7. high fever, serious infection, dyscrasia, multiple organ failure, or incapability to cooperate
8. thrombosis in the active phase
9. For female subjects: they should be surgical sterilized, postmenopausal patients, or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period; The serum or urine pregnancy test must be negative within 7 days before enrollment and must be non lactating. Male subjects: patients who agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period.
10. other conditions confirmed by the multidisciplinary cancer rehabilitation team.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06104267
Study Brief:
Protocol Section:
NCT06104267