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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT06009835
Eligibility Criteria:
Inclusion Criteria:
1. The subjects must be able to understand the procedures and methods of this study, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign a written informed consent form;
2. Patients aged ≥ 18 years old;
3. Solid tumor patients who are depleted of standard treatment or unable to tolerate standard treatment regimens;
4. According to the RECIST solid tumor efficacy evaluation criteria, there should be at least one measurable lesion;
5. ECOG PS score 0-4 (3-4 score only for patients caused by tumor);
6. The expected survival period is not less than 12 weeks;
7. Women of childbearing age must have a Pregnancy test (serum) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the test period and within 8 weeks after the last administration of the test drug;
8. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up;
9. If the main organs function normally, they meet the following standards:
The blood routine examination standard must comply with (no blood transfusion or blood products within 14 days, no correction using G-CSF or other hematopoietic stimulating factors): Hb ≥ 90g/L; ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L;Biochemical examination must meet the following standards: TBIL ≤ 1 × ULN; ALT, AST ≤ 1.5 × ULN; ALP ≤ 2.5 × ULN; BUN and Cr ≤ 1.5 × ULN; Color Doppler echocardiography: left ventricular Ejection fraction (LVEF) ≥ 50%.
Exclusion Criteria:
1. Severe heart disease or discomfort that cannot be treated;
2. Those who suffer from mental illness or abuse of psychotropic substances and are unable to cooperate;
3. Pregnant or lactating female patients;
4. Participating in other clinical trials at the same time;
5. Researchers believe that individuals are not suitable for enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06009835
Study Brief:
Protocol Section:
NCT06009835