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:
NCT07334093
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75 years (inclusive), both sexes eligible.
2. Histologically or cytologically confirmed malignant solid tumor (e.g., lung, breast, gastric, colorectal, genitourinary cancers, etc.).
3. Currently receiving anti-cancer therapy: chemotherapy, radiotherapy, immuno-chemotherapy, targeted therapy, or combinations.
4. Grade ≥3 cancer-therapy-induced thrombocytopenia (PLT \<50×10⁹/L).
5. ECOG performance status 0-1.
6. Estimated life expectancy ≥12 weeks.
7. Women of child-bearing potential must have a negative serum pregnancy test within 7 days before first dose and not be breastfeeding; they must agree to use effective contraception from enrollment through 7 days after the last study drug. Men with partners of child-bearing potential must be surgically sterilized or agree to use effective contraception during the same period and must not donate sperm.
8. Willing to participate, able to provide written informed consent, and expected to comply with the study protocol.
Exclusion Criteria:
1. Pregnant or breastfeeding women.
2. Individuals unable to understand the nature of the study or who have not given informed consent.
3. History of any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep-vein thrombosis, pulmonary embolism) or clinical/laboratory evidence of a hypercoagulable disorder.
4. Cardiac disease within 3 months before screening: grade 3/4 congestive heart failure, arrhythmia requiring medication, myocardial infarction, conditions predisposing to thrombo-embolism (e.g., atrial fibrillation), or QTc prolongation.
5. Thrombocytopenia attributed to: concurrent chemoradiotherapy, non-anti-cancer therapy, oxaliplatin-induced sinusoidal injury, definite immune-mediated thrombocytopenia, severe bleeding symptoms, refractory persistent thrombocytopenia, or bone-marrow involvement proven by biopsy in patients with bone metastases.
6. Significant hepatic impairment:
* No liver metastases: ALT/AST \> 3 × ULN or TBL \> 3 × ULN.
* Liver metastases present: ALT/AST ≥ 5 × ULN or TBL ≥ 5 × ULN.
7. Known or anticipated hypersensitivity/intolerance to TPO-receptor agonists or any ingredient of hetrombopag ethanolamine tablets.
8. Concomitant use of other agents that may affect platelet count (e.g., traditional Chinese medicines, other thrombopoietic agents, antiplatelet drugs).
9. Receipt of any TPO-receptor agonist (eltrombopag, romiplostim, etc.), recombinant human TPO, or recombinant IL-11 within 1 month before screening.
10. Platelet transfusion within 3 days before randomization/first dose.
11. Any condition that, in the investigator's opinion, renders the patient unsuitable for enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07334093
Study Brief:
Protocol Section:
NCT07334093