Sequential Hetrombopag and Recombinant Human Thrombopoietin for Cancer Therapy-Induced Thrombocytopenia

Inclusion Criteria:

• Age 18-75 years (inclusive), male or female;
• Patients with histologically or cytologically confirmed malignant tumors, including but not limited to lung cancer, breast cancer, colorectal cancer, gastric cancer, etc.;
• Currently receiving anticancer therapy in 21-day cycles, with grade 3 or higher thrombocytopenia during treatment, and expected to be able to receive the current anticancer regimen for ≥ 1 more cycle;
• ECOG PS score 0-2;
• With permitted use of red blood cells, erythropoietin, and recombinant human granulocyte colony-stimulating factor consistent with routine clinical practice: absolute neutrophil count (ANC) ≥ 1.0×10^9/L and hemoglobin (Hb) ≥ 80 g/L;
• No significant hepatic impairment;
• No significant renal impairment;
• Expected survival ≥ 12 weeks;
• Female participants of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose, must not be lactating, and must agree to use effective contraception during the study and for 7 days after the last dose of study drug; male participants whose partners are women of childbearing potential must be surgically sterilized or must agree to use reliable contraception from the signing of the informed consent form until 7 days after the last dose of study drug;
• Voluntary participation in this study with signed informed consent and good compliance.

Exclusion Criteria:

• Concomitant hematopoietic system diseases, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative neoplasms, multiple myeloma, and myelodysplastic syndromes;
• Other diseases causing thrombocytopenia other than cancer therapy-induced thrombocytopenia (CTIT) within 6 months before randomization, including but not limited to chronic liver disease and hypersplenism;
• Uncontrolled active infection;
• Tumor bone marrow invasion or bone marrow metastasis;
• Severe cardiac clinical symptoms or diseases within 6 months before randomization;
• Arterial or venous thrombotic events (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism) within 3 months before randomization, or clinical symptoms and history suggestive of thrombophilia;
• Concomitant severe bleeding symptoms or clear clinical manifestations of bleeding tendency, such as gastrointestinal or cerebral hemorrhage;
• Conditions affecting drug absorption (e.g., dysphagia, history of total gastrectomy);
• Receipt of whole-pelvis, whole-spine, or extensive sternal radiotherapy in the previous cycle or expected during the current cycle;
• Treatment with rhIL-11, rhTPO and/or TPO-RA drugs within 7 days before randomization;
• Treatment with romiplostim or romiplostim N01 within 1 month before randomization;
• Platelet transfusion within 3 days before randomization;
• Known or expected allergy or intolerance to the active ingredients or excipients of the study drug;
• Known history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS);
• Known active viral hepatitis;
• Any other condition that, in the investigator's opinion, poses a significant risk to the subject's health or safety or may affect the efficacy evaluation.