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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07492693
Eligibility Criteria:
Inclusion Criteria:
1. age ≥18 years;
2. pathologically confirmed gastrointestinal tumors (including esophageal cancer, gastric cancer, colorectal cancer, etc.);
3. during the previous chemotherapy cycle (N-1 cycle), patients had a minimum platelet count of ≥75×10⁹/L and at least one high-risk bleeding factor (① history of bleeding; ② previous treatment with platinum agents, gemcitabine, cytarabine, anthracyclines, etc.; ③ tumor cell bone marrow infiltration; ④ previous or ongoing radiotherapy, especially to long bones or flat bones such as the pelvis or sternum);
4. during the current chemotherapy cycle (N cycle), patients have a platelet count of ≥100±25×10⁹/L;
5. undergoing treatment cycles of 14 or 21 days and requiring at least one more cycle of therapy.
6. ECOG score: 0-2 points;
7. Adequate hematopoietic, liver, and kidney function:
* Neutrophil count ≥ 1.5 x 10⁹/L
* Hemoglobin ≥ 9.0 g/dL
* Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
* For patients without liver metastasis, AST and ALT ≤ 2.5 times the upper limit of normal;
* Bilirubin ≤ 2 times the upper limit of normal;
* APTT and PT ≤ 1.5 times the upper limit of normal
8. Signed informed consent form.
Exclusion Criteria
1. Previous use of TPO-RA drugs;
2. Pre-treatment conditions that cause thrombocytopenia, such as hypersplenism or immune thrombocytopenia;
3. History of thrombosis;
4. Hematologic diseases (anemia, leukemia, autoimmune hemolytic diseases, etc.);
5. Major cardiovascular diseases (acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, etc.);
6. Pregnant or breastfeeding women;
7. Participation in other drug clinical trials within 4 weeks;
8. Poor compliance, unable to cooperate or report treatment responses;
9. Need for other antiplatelet or platelet-enhancing drugs, including traditional Chinese medicine and herbal preparations;
10. Use of prior platelet-stimulating drugs within 5 half-lives before first dose;
11. Platelet transfusion within 3 days before first dose.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07492693
Study Brief:
Protocol Section:
NCT07492693