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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT03474861
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent form must be obtained prior to any research procedures;
2. Age: 18 Years to 70 Years;
3. The patient's biological parent or child whose age ≥18 years voluntarily donates peripheral blood (200 ml) for the treatment, and who signs the informed consent form independently;
4. Histologically confirmed diagnosis of gastrointestinal cancer;
5. Patients who have received at least one standard treatment (surgery, chemotherapy, radiotherapy, or targeted therapy) or refuse to receive standard treatments;
6. Karnofsky Performance Status (KPS) score ≥ 70
7. Expected survival ≥ 3 months
8. Adequate organ function defined as: ANC≥3.5×10\^9/L, PLT≥50×10\^9/L, ALB≥25g/L, AST≤2.5×ULN, ALT≤2.5×ULN, TBIL≤1.5×ULN
9. If a subject is a female of childbearing potential, she must have a negative urine pregnancy test result.
Exclusion Criteria:
1. Patients who received chemotherapy, large-field radiotherapy or participated in other studies of anti-tumor therapy within 2 weeks before enrollment;
2. Patients who have not recovered from adverse reactions related to above-mentioned procedures;
3. Patients with two types of primary solid tumors;
4. Patients with brain metastases or bone metastases;
5. Patients with poorly controlled hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 90 mmHg), or cardiovascular and cerebrovascular diseases with clinical significance, such as cerebrovascular accident (within 6 months before signing informed consent), myocardial infarction (within 6 months before signing informed consent), unstable angina, congestive heart failure (New York Heart Association Class II or above), or severe arrhythmia which can't be controlled with drugs or have potential impact on treatment;
6. Patients with other serious organic diseases or mental disorders;
7. Patients with systemic or active infection;
8. Patients with positive HIV test result;
9. Patients who have received an organ transplant;
10. Patients who are breastfeeding or pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03474861
Study Brief:
Protocol Section:
NCT03474861