A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia (ExCIT)

Inclusion Criteria

• Male or female, age ≥ 18 years at screening.
• Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
• Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 14- or 21-day treatment cycles.
• Platelet count < 85 x 109/L at enrollment.
• For Part B, experiencing a chemotherapy delay of ≥ 7 days due to CIT.
• At least 2 scheduled chemotherapy cycles of the same treatment regimen as was used prior to enrollment.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
• Life expectancy ≥6 months.
• Signed ICF for voluntary participation in the study and good compliance.

Exclusion Criteria

• WHO Grade ≥ 2 bleeding within 14 days prior to screening.
• Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
• Hematologic malignancies.
• 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.
• Untreated brain metastases; or with leptomeningeal metastasis.
• Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
• Severe cardiovascular disorders or interventions within 6 months.
• Have arterial/venous thrombosis with anticoagulation not tolerated for at least 6 weeks.
• Known bleeding disorders, platelet dysfunction.
• Severe haemorrhage during screening (e.g., gastrointestinal or intracranial hemorrhage) within 28 days prior to enrolment.
• Previous treatment with thrombopoietin receptor agonists (TPO-RAs) within 14 days prior to enrolment.
• Platelet transfusion within 72 hours prior to enrollment.
• Acute or uncontrolled hepatitis B&C infection.
• Human immunodeficiency virus (HIV) infection.