Oxaliplatin-containing chemotherapy–induced thrombocytopenia
Conditions
Interventions
Sponsors
Zhongshan Hospital Affiliated to Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >=18 years at the time of signing the informed consent form, with no restriction on sex. 2.Histologically or cytologically confirmed malignant solid tumor, regardless of tumor stage. 3.Currently receiving or scheduled to receive one of the following oxaliplatin-based chemotherapy regimens for adjuvant treatment or advanced disease: capecitabine or S-1 combined with oxaliplatin (CAPOX/XELOX or SOX), administered once every 3 weeks. Concomitant use of antiangiogenic agents, such as bevacizumab, or targeted agents, such as epidermal growth factor receptor–targeted therapies, is permitted. 4.Classified as being at high risk of chemotherapy-induced thrombocytopenia (CIT) according to the risk assessment model. The probability of CIT will be calculated using the XL-CTIT-PP logistic regression model previously developed by our research team. The model includes six independent risk factors: primary tumor site, chemotherapy regimen, concomitant targeted therapy, prechemotherapy platelet count, aspartate aminotransferase level, and albumin level. Patients with a predicted probability of CIT >40% will be classified as high risk. 5.Expected to receive at least four additional cycles of chemotherapy after enrollment. 6.Eastern Cooperative Oncology Group performance status (ECOG PS) score <=2. 7.Able to fully understand the study, willing to participate voluntarily, and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.The patient had experienced thrombocytopenia during any chemotherapy cycle before the first administration of romiplostim N01, defined as a platelet count (PLT) 300 × 10^9/L before the first administration of the study drug; only patients with PLT <=300 × 10^9/L are eligible. 3.Presence of other hematologic disorders or hematologic malignancies, including leukemia, lymphoma, immune thrombocytopenia, aplastic anemia, or myelodysplastic syndrome. 4.Bone marrow involvement or bone marrow metastasis of the tumor. 5.Major surgery within 28 days before enrollment or minor surgery within 3 days before enrollment. 6.Any arterial or venous thrombotic event within 3 months before screening. 7.Clinical manifestations of severe bleeding within 2 weeks before screening. 8.Platelet transfusion within 2 days before enrollment. 9.Severe cardiovascular disease within 6 months before screening. 10.Active chronic hepatitis B or hepatitis C infection, or a positive human immunodeficiency virus antibody test. 11.Use of antithrombotic medications, including heparin, warfarin, or aspirin, within 7 days before the first administration of the study drug. 12.Female participants who are pregnant or breastfeeding. 13.Known hypersensitivity to romiplostim, romiplostim N01, or any of their excipients. 14.Any other condition that, in the investigator’s judgment, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of any-grade CIT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of grade 3–4 CIT;Incidence of grade >=2 CIT; | — |
Countries
China
Contacts
Public ContactLi Xiao
Zhongshan Hospital Affiliated to Xiamen University
Outcome results
None listed