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 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT07286032
Eligibility Criteria:
Inclusion Criteria:
1. Male or female gender, age ≥18 years at screening.
2. Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma \[NSCLC\], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
3. Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
5. Life expectancy ≥6 months.
6. Signed ICF for voluntary participation in the study and good compliance.
Exclusion Criteria:
1. Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
2. Hematologic malignancies.
3. Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day 1.
4. Untreated brain metastases; or with leptomeningeal metastasis.
5. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
6. Severe cardiovascular disorders or interventions within 6 months
7. Have arterial/venous thrombosis within 6 months
8. Known bleeding disorders, platelet dysfunction
9. Severe haemorrhage during screening
10. Acute or uncontrolled hepatitis B\&C infection
11. Human immunodeficiency virus (HIV) infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07286032
Study Brief:
Protocol Section:
NCT07286032