Efficacy and Safety of Hetrombopag in Preventing Chemotherapy-induced Thrombocytopenia in Gastrointestinal Tumors

Inclusion criteria

• age ≥18 years;
• pathologically confirmed gastrointestinal tumors (including esophageal cancer, gastric cancer, colorectal cancer, etc.);
• 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);
• during the current chemotherapy cycle (N cycle), patients have a platelet count of ≥100±25×10⁹/L;
• undergoing treatment cycles of 14 or 21 days and requiring at least one more cycle of therapy.
• ECOG score: 0-2 points;
• 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
• Signed informed consent form.

Exclusion criteria

• Previous use of TPO-RA drugs;
• Pre-treatment conditions that cause thrombocytopenia, such as hypersplenism or immune thrombocytopenia;
• History of thrombosis;
• Hematologic diseases (anemia, leukemia, autoimmune hemolytic diseases, etc.);
• Major cardiovascular diseases (acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, etc.);
• Pregnant or breastfeeding women;
• Participation in other drug clinical trials within 4 weeks;
• Poor compliance, unable to cooperate or report treatment responses;
• Need for other antiplatelet or platelet-enhancing drugs, including traditional Chinese medicine and herbal preparations;
• Use of prior platelet-stimulating drugs within 5 half-lives before first dose;
• Platelet transfusion within 3 days before first dose.